pharmaceutical microbiology (1)

8182019 Pharmaceutical Microbiology (1)

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Table of Contents

Pharmaceutical Microbiology 1

St983154ains specified by official microbial assays 2United States Pharmacopeia (USP) 2European Pharmacopeia (EP) Edition 81 5 Japanese Pharmacopeia (JP) 7

St983154ains listed by genus and species 10

ATCC provides research and development tools and reagents as well as relatedbiological material management se983154vices consistent with its mission toacquire authenticate prese983154ve develop and distribute standard referencemicroorganisms cell lines and related materials for research in the life sciences

For over 85 years ATCC has been a leading

provider of high-quality biological materialsand standards to the life science communityWe are an independent 501(c)(3) non-profitentity focused on scientific enablement atuniversities research institutes governmentagencies and commercial research labsOur diverse and comprehensive resourcesin cell biology and microbiology have beencent983154al to the growth of the biotechnologyage ATCC has as its core mission to source

authenticate and fu983154ther develop products

and se983154vices essential to the needs of basicand applied life science work

ATCC distributes to more than 165countries on 6 continents and has a growinginternational network of 12 distributionpa983154tners Our inf983154astructure and experiencein biological materials logistics enables us towork effectively with researchers no mattewhere they are located

THE ESSENTIALS

OF LIFE SCIENCE

RESEARCH

GLOBALLY

DELIVEREDtrade



PHARMACEUTICAL MICROBIOLOGYPharmaceutical companies are well versed in the impo983154tant role of microbiological testing in its basic functions ndash product research anddevelopment process validation manufacturing and quality control

The pharmaceutical indust983154y looks to ATCC to provide top-quality fully cha983154acterized st983154ains necessa983154y to maintain the highest levels ofproduct integrity and reputation With ATCC Genuine Culturesreg pharmaceutical customers can rely on

bull Polyphasic identification and st983154ain cha983154acterization

bull

Proprieta983154y systems for managing st983154ain stocksbull Meticulous propagation prese983154vation and sto983154age protocols

bull Robust quality systems

bull Over 85 years of se983154vice

Whenever possible ATCC balances t983154aditional biochemical testing methods with automated phenotypic and genotypic analyses This providehighly accu983154ate identification across a wide ar983154ay of microorganisms and can help avoid the pitfalls of misidentification painful recalls andregulato983154y repercussions Each vial contains a minimal passage descendant of the original material and has been handled only by ATCC

ATCC is a trusted scientific resource and an ISO 9001 ce983154tified ISO 17025 and ISO Guide 34 accredited organization Our customer andtechnical se983154vice teams as well as our global network of authorized distributors understand the complexities of distributing and suppo983154tingmicrobial cultures worldwide Our labo983154ato983154y procedures maintain st983154ains carefully safely and effectively to ensure optimal viability backedby our war983154anty

St983154ains provided for key pharmaceutical applications are listed in two ways

bull St983154ains specified by United States Pharmacopeia (USP) European Pharmacopeia (EP) or Japanese Pharmacopeia (JP) official microbialassays

bull St983154ains listed alphabetically by genus and species paired with relevant applications

To learn more visit our website at wwwatccorgpharmaceutical



STRAINS SPECIFIED BY OFFICIAL MICROBIAL ASSAYSOfficial Microbial Assays United States Pharmacopeia (USP)

Application ATCCreg No

USP CHAPT ER983098 98310051983102 ANTIMICROB IAL EFFECTI VENESS TESTING USP 37983085NF32 2014

Candida albicans 3147 10231trade

Aspergillus b983154asi983148iensis WLRI 034(120) 16404trade

Escherichia co983148i Crooks 8739trade

Pseudomonas aeruginosa R Hugh 813 9027trade

Staphylococcus aureus subsp aureus FDA 209 6538trade

USP CHAPTER983098 98310061983102 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS983098 MICROBIAL ENUMERATION TESTS USP 37983085NF32 2014



Bacillus subti983148is subsp spizizenii NRS 231 6633trade



USP CHAPTER983098 98310062983102 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS983098 TESTS FOR SPECIFIED MICROORGANISMS USP 37983085NF32 2014


Pseudomonas aeruginosa R Hugh 813 9027tradeEscherichia co983148i Crooks 8739trade

Sa983148monella enterica subsp enterica serovar Typhimurium CDC 6516-60 14028trade


Clostridium sporogenes LS McClung 2006 11437trade

Clostridium sporogenes 19404trade

USP CHAP TER983098 98310063983102 MYCOPLAS MA TESTS USP 37983085NF32 2014

Acholeplasma laidlawii PG8 23206trade

Mycoplasma gal983148isepticum PG 31 19610trade

Mycoplasma fermentans PG 18 19989trade

Mycoplasma hyorhinis BTS-7 17981trade

Mycoplasma o983154ale CH 19299 23714tradeMycoplasma pneumoniae FH st983154ain of Eaton Agent 15531trade

Mycoplasma synoviae WVU 1853 25204trade

USP CHAP TER983098 98310071983102 STERIL ITY TESTS USP 37983085NF32 2014








Kocuria rhizophila FDA st983154ain PCI 1001 9341tradeBacteriodes vulgatus 8482trade

USP CHAP TER983098 98310081983102 ANT IBIOTICS983085MICRO BIAL ASSAYS USP 37983085NF32 2014

Saccharomyces cerevisiae 9763trade

Micrococcus luteus 13021 10240trade

Mycobacterium smegmatis 607trade

Pseudomonas aeruginosa 25619trade

Staphylococcus aureus subsp aureus FDA 29737trade

Bordetella bronchiseptica NRRL B-140 4617trade


Kocuria rhizophila FDA st983154ain PCI 1001 9341trade



Official Microbial Assays United States Pharmacopeia (USP)


Staphylococcus epidermidis FDA st983154ain PCI 1200 12228trade


Enterococcus hi983154ae FDA M19 10541trade

Staphylococcus aureus subsp aureus 3R7089 st983154ain Oxford 9144trade

Klebsiella pneumoniae subsp pneumoniae 10031trade

Escherichia co983148i MacLeod 10536trade

USP CHA PTER983098 98310091983102 C ALCIUM PANTOT HENATE ASSAY USP 37983085NF32 2014

Lactobacillus plantarum 17-5 8014trade

USP CHA PTER983098 983100115983102 DEXPANTHENOL ASSAY USP 37983085NF32 2014

Pediococcus acidilactici 8042trade

USP CHA PTER983098 983100171983102 VITAMIN B12 ACTIVITY ASSAY USP 37983085NF32 2014

Lactobacillus leichmannii 313 7830trade

USP CHAP TER983098 983100441983102 NIACIN O R NIACIN AMIDE ASSAY USP 37983085NF32 2014


USP CHA PTER983098 9831001035983102 BIOLOGICA L INDIC ATORS USP 37983085NF32 2014

Geobacillus stearothermophilus NCA 26 12980trade

USP CHAPT ER983098 9831001046983102 CELLULA R AND TISSUE983085BA SED PRODUCT S USP 37983085NF32 2014

Hybrid MoloneyAmphotropic Murine leukemia virus (MoA-MuLv) VR-1448trade


USP CHAP TER983098 9831001072983102 DISINFECTANTS A ND ANT ISEPTICS USP 37983085NF32 2014

Escherichia co983148i AMC 198 11229trade


Pseudomonas aeruginosa PRD-10 15442trade



Penicillum ch983154ysogenum Wis 49-133 11709trade


Bacillus subti983148is PRD 66 19659trade

USP CHAPTER 983098 9831001211983102 STERILIZATION AN D STERILITY ASSU RANCE OF COMPEN DIAL ARTICL ES USP 37983085NF32 2014

Geobacillus stearothermophilus 7953trade

Bacillus atrophaeus NRS 1221A 9372trade

USP CHA PTER983098 98310012291983102 STEAM STERIL IZATION BY DIRECT CO NTACT USP 37983085NF32 2014



USP DIETARY SUPPLEMEN T CHAPTER983098 9831002021983102 MICROBIAL ENUM ERATION TESTS 983085 NUTRITION AL AND DIETARY SUPPLEME NTS USP 37983085NF32 2014


Sa983148monella enterica subsp enterica serovar Typhimurium NCTC 74 13311trade





USP DIETARY SUPP LEMENTS 983098 OIL983085 AND WATER983085SOLUBLE VITAMINS C APSULES USP 37983085NF32 2014




USP DIETARY SUPP LEMENTS 983098 OIL983085 AND WATER983085SOLUBLE VITAMINS O RAL SOLUTIO N USP 37983085NF32 2014








USP DIETARY SUPP LEMENTS983098 O IL983085 AND WATER983085SOLUBLE VITAMINS TABL ETS USP 37983085NF32 2014



USP DIETARY SUPP LEMENTS983098 O IL983085 AND WATER983085SOLUBLE VITAMINS WI TH MINERAL S CAPSULES USP 37983085NF32 2014




USP DIETARY SUPPLEM ENTS983098 OIL983085 AND WATER983085SOLUBLE VITAMINS WIT H MINERALS ORA L SOLUTION USP 37983085NF32 2014




USP DIETARY SUPP LEMENTS983098 OIL983085 AND WATER983085SOLUBLE VITAMINS W ITH MINERAL S TABLETS USP 37983085NF32 2014



USP DIETARY SUPP LEMENTS 983098 WATER983085SOLUBLE VITAMINS CA PSULES USP 37983085NF32 2014



USP DIETARY SUPP LEMENTS 983098 WATER983085SOLUBLE VITAMINS TABL ETS USP 37983085NF32 2014



USP DIETARY SUPPLEM ENTS983098 WATER983085SOLUBLE VITAMIN S WITH MINERAL S CAPSULES USP 37983085NF32 2014




USP DIETARY SUPPLE MENTS983098 WATER983085SOLUBLE VITAMIN S WITH MINERAL S ORAL SOLUTION USP 37983085NF32 2014




USP DIETARY SUPP LEMENTS 983098 WATER983085SOLUBLE VITAMINS WIT H MINERAL S TABLETS USP 37983085NF32 2014



USP MONOGR APHS983098 BIOLOG ICAL INDIC ATOR FOR DRY983085HEAT STERILIZATION PAPER CAR RIER USP 37983085NF32 2014


USP MONOGRA PHS983098 BIOLOGICA L INDICATOR FOR ETHYL ENE OXIDE STERILIZATIO N PAPER CARRIER USP 37983085NF32 2014


USP MONOGRA PHS983098 BIOLOGICA L INDICATOR FOR STEAM STE RILIZATION PAPER CARRIE R USP 37983085NF32 2014



USP MONOGR APHS983098 PEN ICILLAMIN E USP 37983085NF32 2014


USP MONOGRAPHS983098 PENICILLIN G PROCAINE AND NOVOBIOCIN SODIUM INTRAMAMMARY INFUSION USP 37983085NF32 2014

Staphylococcus aureus subsp aureus PCI 1209N 12692trade

USP MONOGRA PHS983098 TETRAC YCLINE HYDROCHLOR IDE AND NOVOBIOCIN S ODIUM TABLETS USP 37983085NF32 2014




Official Microbial Assays European Pharmacopeia (EP) Edition 81


EP 261 STERIL ITY




Staphylococcus aureus subsp aureusRosenbach FDA 209 6538trade



EP 267 MYCOPLAS MAS

Mycoplasma fermentans PG18 19989trade

Mycoplasma pneumoniae FH st983154ain of Eaton Agent 15531trade


Mycoplasma gal983148isepticum PG31 19610trade

Mycoplasma o983154ale CH 19299 23714trade



EP 2612 MICROBIAL EXAMINATION OF NON983085STERILE PRODUCTS983098 MICROBIAL ENUMERATION TESTS

Staphylococcus aureus subsp aureusFDA 209 6538trade





EP 2613 MICROBIAL EXAMINATION OF NON983085STERILE PRODUCTS983098 TEST FOR SPECIFIED MICRO983085ORGANISMS






EP 2627 MICROBIOLOGIC AL CONTROL OF CEL LULAR PRODUC TS



Propionibacterium acnes Ge983154ath 11827trade



Streptococcus pyogenes Bruno 19615trade

Bacteroides f983154agi983148is VPI 2553 25285trade

Staphylococcus aureus subsp aureus Rosenbach FDA 209 6538trade



Yersinia enteroco983148itica subsp enteroco983148itica 33114 9610trade

EP 2631 MICROBIOLOGICAL EXAMINATION OF HERBAL MEDICINAL PRODUCTS FOR ORAL USE










EP 272 MICROBIOLOGIC AL ASSAYS OF ANTIBIOTI CS






Bacillus pumilus 14884trade

Bordetella bronchiseptica 4617trade






Escherichia co983148i 397E 9637trade


EP 512 BIOLOGICAL IN DICATORS OF STERILIZATIO N

Bacillus pumilus E601 27142trade



EP 513 EFFICACY OF ANT IMICROBIAL P RESERVATION






EP MONOGRAPHS983098 PENICILLAMINE


EP MONOGRAPHS983098 WATER FOR IN983146ECTIONS



EP MONOGRAPHS983098 WATER FOR PREPARATION OF EXTRACTS



EP MONOGRAP HS983098 WATER HIGHLY PURIFIED



EP MONOGRAPHS983098 WATER PURIFIED





Official Microbial Assays Japanese Pharmacopeia (JP)


983146P 16 405 I MICROBIOLOGICAL EXAMI NATION OF NON983085STERI LE PRODUCTS983098 TOTAL VIA BLE AEROBIC COUN T






983146P 16 405 II MICROBIOLOGICAL EXAMINATION OF NON983085STERILE PRODUCTS983098 TESTS FOR SPECIFIED MICRO983085ORGANISMS






Clostridium sporogenes LS McClung 2006 11437trade or 19404trade

983146P 16 406 STERILITY TEST






Aspergillus b983154asi983148iensis WLRI 034 16404trade

983146P 16 502 MICROBIAL LIM IT TEST FOR CRU DE DRUGS




Candida albicans 3147 or 132 10231trade or 2091trade

983146P 16 MONOGRAPHS983098 AMPHOTERICIN B

Saccharomyces cerevisiae NRRL Y-567 9763trade

983146P 16 MONOGRAPHS983098 AMPICILLIN SODIUM


983146P 16 MONOGRAPHS983098 ARBEKACIN SULFATE


983146P 16 MONOGRAPHS983098 BACITRACIN


983146P 16 MONOGRAPHS983098 BEKANAMYCIN SULFATE


983146P 16 MONOGRAPHS983098 BENZYLPENICILLIN POTASSIUM


983146P 16 MONOGRAPHS983098 BLEOMYCIN HYDROCHLORIDE


983146P 16 MONOGRAP HS983098 BLEOMYCIN SULFATE


983146P 16 MONOGRAPHS983098 CLOXACILLIN SODIUM HYDRATE

Bacillus subti983148is subsp spizizeniiNRS 231 6633trade

983146P 16 MONOGRAPHS983098 CYCLOSERINE


983146P 16 MONOGRAPHS983098 DIBEKACIN SULFATE


983146P 16 MONOGRAPHS983098 DICLOXACILLIN SODIUM HYDRATE






983146P 16 MONOGRAP HS983098 ENVIOMYCIN SULFATE


983146P 16 MONOGRAPHS983098 ERYTHROMYCIN


983146P 16 MONOGRAPHS983098 ERYTHROMYCIN ETHYLSUCCINATE


983146P 16 MONOGRAPHS983098 ERYTHROMYCIN LACTOBIONATE


983146P 16 MONOGRAPHS983098 ERYTHROMYCIN STEARATE


983146P 16 MONOGRAP HS983098 FRADIOMYCIN SULFATE


983146P 16 MONOGRAP HS983098 GENTAMICIN SULFATE


983146P 16 MONOGRAPHS983098 GRAMICIDIN


983146P 16 MONOGRAP HS983098 983146OSAMYCIN


983146P 16 MONOGRAPHS983098 983146OSAMYCIN PROPIONATE


983146P 16 MONOGRAPHS983098 KANAMYCIN MONOSULFATE


983146P 16 MONOGRAPHS983098 KANAMYCIN SULFATE


983146P 16 MONOGRAPHS983098 KITASAMYCIN


983146P 16 MONOGRAP HS983098 KITASAMYCIN ACETATE


983146P 16 MONOGRAPHS983098 KITASAMYCIN TARTRATE


983146P 16 MONOGRAPHS983098 MICRONOMICIN SULFATE


983146P 16 MONOGRAPHS983098 MIDECAMYCIN


983146P 16 MONOGRAPHS983098 MIDECAMYCIN ACETATE


983146P 16 MONOGRAP HS983098 NYSTATIN


983146P 16 MONOGRAP HS983098 PEPLOMYCIN SULFATE


983146P 16 MONOGRAP HS983098 RIBOSTAMYCIN SULFATE


983146P 16 MONOGRAPHS983098 ROKITAMYCIN


983146P 16 MONOGRA PHS983098 SODIUM FUSIDATE


983146P 16 MONOGRAPHS983098 SPECTINOMYCIN HYDROCHLORIDE HYDRATE

Klebsiella pneumoniae subsp pneumoniae PCI 602 10031trade





983146P 16 MONOGRAPHS983098 SPIRAMYCIN ACETATE


983146P 16 MONOGRAPHS983098 STREPTOMYCIN SULFATE


983146P 16 MONOGRAPHS983098 SULBENICILLIN SODIUM


983146P 16 MONOGRAPHS983098 TEICOPLANIN


983146P 16 MONOGRAPHS983098 TOBRAMYCIN


983146P 16 MONOGRAPHS983098 VANCOMYCIN HYDROCHLORIDE


983146P 16 MONOGRAPHS983098 ZINOSTATIN STIMALAMER


983146P 16 G3 BIOTECHNOLOGICALBIOLOGICAL PRODUCTS983098 MYCOPLASMA TESTING FOR CELL SUBSTRATES USED FOR THE PRODUCTION OFBIOTECHNOLOGICALBIOLOGICAL PRODUCTS


Mycoplasma o983154ale CH 19299 23714tradeMycoplasma hyorhinis DBS 1050 or BTS-7 29052trade or 17981trade

983146P 16 G4 MICROORGANISMS983098 PRESERVATIVES983085EFFECTIVENESS TESTS






983146P 16 G4 MICROORGANISMS983098 TERMINAL STERILIZATION AND STERILIZATION INDICATORS

Brevundimonas diminuta FDA st983154ain PCI 818 19146trade


Bacillus atrophaeus NRS 1221A 9372trade983146P 16 G8 QUALITY CONTROL OF WATER FOR PHARMA CEUTICAL USE




Pseudomonas protegens 1 17386trade

Methylobacterium extorquens NBRC 15911 BAA-2500trade


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STRAINS LISTED BY GENUS AND SPECIESSt983154ains for Pharmaceutical Microbiology

St983154ain ATCCreg No Application

Acholeplasma laidlawii PG8 23206trade EP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test


EP 513 Efficacy of antimicrobial prese983154vation EP 261 Sterility EP 2627 MicrobiologicalControl of Cellular Products EP 2612 Microbial examination of non-sterile products MicrobialEnume983154ation Tests USP 37 Disinfectants and Antiseptics lt1072gt USP 37 Microbial limit tests ndashDieta983154y supplements - Prepa983154ato983154y testing Growth Promotion Testing lt2021gt lt51gt AntimicrobialEffectiveness Testing USP 37-NF32 2014 USP 37 Microbiological Examination of NonsterileProducts Microbial Enume983154ation Tests lt61gt Sterility Tests lt71gt USP 37-NF32 2014 JP 16 405 IMicrobiological Examination of Non-sterile Products Total Viable Aerobic Count JP 16 406 Sterilitytest JP 16 G4 Microorganisms Prese983154vatives-Effectiveness Test


EP 512 Biological indicators of sterilization USP Chapter lt1211gt Sterilization and sterility assu983154anceof compendial a983154ticles USP 37-NF32 2014 USP Chapter lt1035gt Biological Indicators USP 37-NF322014 USP Monog983154aphs Biological Indicator for D983154y-Heat Sterilization Paper Carrier USP 37-NF322014 USP Monog983154aphs Biological Indicator for Ethylene Oxide Sterilization Paper Carrier USP 37-NF32 2014 JP 16 G4 Microorganisms Terminal Sterilization and Sterilization Indicators

Bacillus pumilus E601 27142tradeEP 512 Biological indicators of sterilization USP Chapterlt1211gt Sterilization and sterility assu983154anceof compendial a983154ticles

Bacillus pumilus 14884trade EP 272 Microbiological assays of antibiotics


EP 261 Sterility EP 2627 Microbiological Control of Cellular Products EP 2631 MicrobiologicalExamination of Herbal Medicinal Products for O983154al Use EP 272 Microbiological assays of antibioticsEP 2612 Microbial examination of non-sterile products Microbial Enume983154ation Tests EP 2613Microbial examination EP Monog983154aphs Water for Injections EP Monog983154aphs Water for Prepa983154ationof Ext983154acts EP Monog983154aphs Water Highly Purified EP Monog983154aphs Water Purified USP 37 Microbiallimit tests ndash Dieta983154y supplements - Prepa983154ato983154y testing Growth Promotion Testing lt2021gt lt81gtAntibiotics ndash Microbial Assays USP 37-NF32 2014 USP 37 Microbiological Examination of NonsterileProducts Microbial Enume983154ation Tests lt61gt lt71gt Sterility Tests USP 37-NF32 2014 JP 16 405 IMicrobiological examiniation of non-sterile products total viable aerobic count JP 16 406 Sterilitytest JP 16 502 Microbial limit test for crude drugs JP 16 Ampicillin sodium Arbekacin sulfateBekanamycin sulfate Cloxacillin sodium hyd983154ate Cycloserine Dibekacin sulfate Dicloxacillin sodiumhyd983154ate Enviomycin sulfate Josamycin Josamycin propionate Kanamycin monosulfate Kanamycinsulfate Kitasamycin Kitasamycin acetate Kitasamycin ta983154t983154ate Micronomicin sulfate MidecamycinRibostamycin sulfate Spi983154amycin acetate Streptomycin sulfate Sulbenicillin sodium TeicoplaninTob983154amycin Vancomycin hydrochloride

Bacillus subti983148is PRD 66 19659trade USP Chapter lt1072gt Disinfectants and Antiseptics

Bacteroides f983154agi983148is VPI 2553 25285trade EP 2627 Microbiological Control of Cellular Products

Bacteroides vulgatus 8482trade USP Chapter lt71gt Sterility Tests USP 37-NF32 2014

Bordetella bronchiseptica NRRL B-140 4617tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial Assays USP37-NF32 2014

Brevundimonas diminuta FDA st983154ain PCI 818 19146tradeUSP Chapter lt1211gt Sterilization and sterility assu983154ance of compendial a983154ticles USP 37-NF322014 JP 16 G4 Microorganisms Terminal Sterilization and Sterilization Indicators

Candida albicans 132 2091tradeEP 261 Sterility USP Chapter lt1072gt Disinfectants and Antiseptics JP 16 502 Microbial Limit Testfor Crude Drugs


EP 513 Efficacy of antimicrobial prese983154vation EP 261 Sterility EP 2627 MicrobiologicalControl of Cellular Products EP 2612 Microbial examination of non-sterile products MicrobialEnume983154ation Tests EP 2613 Microbial examination of non-sterile products Test for SpecifiedMicro-organisms USP Chapter lt1072gt Disinfectants and Antiseptics USP 37 Microbial limit testsndash Dieta983154y supplements - Prepa983154ato983154y testing Growth Promotion Testing lt2021gt lt51gt AntimicrobialEffectiveness Testing USP 37-NF32 2014 USP 37 Microbiological Examination of NonsterileProducts Microbial Enume983154ation Tests lt61gt USP 37 Microbiological Examination of NonsterileProducts Tests for Specified Microorganisms lt62gt Sterility Tests lt71gt USP 37-NF32 2014 JP 16

405 I Microbiological Examination of Non-Sterile Products Total Viable Aerobic Count JP 16 405 IIMicrobiological Examination of Non-Sterile Products Tests for Specified Micro-organisms JP 16 406Sterility Test JP 16 502 Microbial Limit Test for Crude Drugs JP 16 G4 Microorganisms Prese983154vatives-Effectiveness Tests


EP 2627 Microbiological Control of Cellular Products EP 2613 Microbial examination ofnon-sterile products Test for Specified Micro-organisms USP 37 Chondroitin Sulfate Sodium USP37 Microbiological Examination of Nonsterile Products Tests for Specified Microorganisms lt62gtSterility Tests lt71gt USP 37-NF32 2014 Dieta983154y Supplements Chondroitin Sulfate Sodium USP37-NF32 2014 JP 16 405 II Microbiological Examination of Non-Sterile Products Tests for SpecifiedMicro-Organisms JP 16 406 Sterility Test



St983154ains for Pharmaceutical Microbiology



EP 261 Sterility EP 2627 Microbiological Control of Cellular Products EP 2613 Microbialexamination of non-sterile products Test for Specified Micro-organisms USP 37 Chondroitin SulfateSodium USP 37 Microbiological Examination of Nonsterile Products Test USP 37 MicrobiologicalExamination of Nonsterile Products Tests for Specified Microorganisms lt62gt lt71gt Sterility TestsUSP 37-NF32 2014 JP 16 405 II Microbiological Examination of Non-Sterile Products Tests forSpecified Micro-Organisms JP 16 406 Sterility Test

Enterococcus hi983154ae FDA M19 10541tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 G983154amicidin

Escherichia co983148i MacLeod 10536tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial Assays USP37-NF32 2014 Tet983154acycline Hydrochloride and Novobiocin Sodium Tablets USP 37-NF32 2014

Escherichia co983148i AMC 198 11229trade USP Chapter lt1072gt Disinfectants and Antiseptics USP 37- NF32 2014


EP 2613 Microbial examination of non-sterile products Test for Specified Micro-organisms EP2631 Microbiological Examination of Herbal Medicinal Products for O983154al Use EP 513 Efficacy ofantimicrobial prese983154vation USP 37 Microbiological Examination of Nonsterile Products Tests forSpecified Microorganisms lt62gt USP 37 Microbial limit tests ndash Dieta983154y supplements - Prepa983154ato983154ytesting Growth Promotion Testing lt2021gt lt51gt Antimicrobial Effectiveness Testing USP 37-NF322014 USP 37 Microbiological Examination of Nonsterile Products Tests for Specified Microorganismslt62gt JP 16 405 II Microbiological Examination of Non-Sterile Products Tests for Specified Micro-Organisms JP 16 502 Microbial Limit Test for Crude Drugs JP 16 G4 Microorganisms Prese983154vatives-Effectiveness Tests JP 16 G8 Quality Control of Water for Pharmaceutical Use

Escherichia co983148i 397E 9637trade EP 272 Microbiological assays of antibiotics


EP 512 Biological indicators of sterilization USP Chapter lt1211gt Sterilization and sterility

assu983154ance of compendial a983154ticles USP 37-NF32 2014 USP Monog983154aphs Biological Indicators forSteam Sterilization Paper Carrier USP 37-NF32 2014 USP Chapter lt12291gt Steam Sterilization byDirect Contact USP 37-NF32 2014 JP 16 G4 Microorganisms Terminal Sterilization and SterilizationIndicators

Geobacillus stearothermophilus NCA 26 12980tradeUSP Chapter lt12291gt Steam Sterilization by Direct Contact USP 37-NF32 2014 USP Chapterlt1035gt Biological Indicators USP 37-NF32 2014 USP Monog983154aphs Biological Indicator for SteamSterilization Paper carrier USP37-NF32 2014

Hybrid MoloneyAmphotropic murineleukemia virus (MoA-MuLv) 4070Aenvelope st983154ain

VR-1448trade USP Chapterlt1046gt Cell and Gene The983154apy Products - Analytical Methodologies USP 37-NF32 2014



Klebsiella pneumoniae subsp pneumoniaePCI 602

10031tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 Spectinomycin Hydrochloride Hyd983154ate

Kocuria rhizophila FDA st983154ain PCI 1001 9341tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial Assays USP37-NF32 2014 Penicillamine USP 37-NF32 2014 lt71gt Sterility Tests USP 37-NF32 2014


USP Chapter lt171gt Vitamin B12 Activity Assay USP 37-NF32 2014 USP Dieta983154y Supplements Oil-andWater-Soluble Vitamins with Mine983154als Tablets USP 37-NF32 2014 USP Dieta983154y Supplements Oil- andWater-Soluble Vitamins Capsules USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins O983154al Solution USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-SolubleVitamins Tablets USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins withMine983154als Capsules USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitaminswith Mine983154als O983154al Solution USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble VitaminsTablets USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154alsCapsules USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154alsO983154al Solution USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154alsTablets USP 37-NF32 2014


USP Chapter lt91gt Calcium Pantothenate Assay USP 37-NF32 2014 USP Chapter lt441gt Niacin orNiacinamide Assay USP 37-NF32 2014 Dieta983154y Supplements Oil-and Water-Soluble Vitamins with

Mine983154als Tablets USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble VitaminsCapsules USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins O983154alSolution USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins Tablets USP37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins with Mine983154als CapsulesUSP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins with Mine983154als O983154alSolution USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins Tablets USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154als Capsules USP 37-NF322014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154als O983154al Solution USP 37-NF322014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154als Tablets USP 37-NF32 2014

Methylobacterium extorquens NBRC 15911 BAA-2500trade JP 16 G8 Quality Control of Water for Pharmaceutical Use

Micrococcus luteus 13021 10240tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 Bacit983154acin

Kocuria rhizophila FDA st983154ain PCI 1001 9341trade JP 16 Midecamycin Acetate Rokitamycin Zinostatin Stimalamer





Mycobacterium smegmatis 607tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 Bleomycin Hydrochloride Bleomycin Sulfate Peplomycin Sulfate

Mycoplasma fermentans PG 18 19989trade USP Chapter lt63gt Mycoplasma test EP 267 Mycoplasmas

Mycoplasma gal983148isepticum PG31 19610trade EP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test

Mycoplasma hyorhinis BTS-7 17981tradeEP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test JP 16 G3 BiotechnologicalBiologicalProducts Mycoplasma Testing for Cell Subst983154ates used for the Production of BiotechnologicalBiological Products

Mycoplasma hyorhinis DBS 1050 29052trade JP 16 G3 BiotechnologicalBiological Products Mycoplasma Testing for Cell Subst983154ates used for theProduction of BiotechnologicalBiological Products

Mycoplasma o983154ale CH 19299 23714tradeEP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test JP 16 G3 BiotechnologicalBiologicalProducts Mycoplasma Testing for Cell Subst983154ates used for the Production of BiotechnologicalBiological Products

Mycoplasma pneumoniae FH st983154ain of EatonAgent

15531tradeEP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test JP 16 G3 BiotechnologicalBiologicalProducts Mycoplasma Testing for Cell Subst983154ates used for the Production of BiotechnologicalBiological Products

Mycoplasma synoviae WVU 1853 25204trade EP 267 Mycoplasmas USP Chapter lt63gt Mycoplasma test


USP Chapter lt115gt Dexpanthenol Assay USP 37-NF32 2014 USP Dieta983154y Supplements Oil- andWater-Soluble Vitamins Capsules USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins O983154al Solution USP 37-NF32 2014 USP Dieta983154y Supplements Oil- and Water-Soluble Vitamins with Mine983154als Capsules USP 37-NF32 2014 USP Dieta983154y Supplements Oil- andWater-Soluble Vitamins with Mine983154als O983154al Solution USP 37-NF32 2014 USP Dieta983154y Supplements

Water-Soluble Vitamins with Mine983154als Capsules USP 37-NF32 2014 USP Dieta983154y Supplements Water-Soluble Vitamins with Mine983154als O983154al Solution USP 37-NF32 2014 Dieta983154y Supplements Water-solubleVitamins Capsules USP 37-NF32 2014

Penicil983148ium ch983154ysogenum Wis 49-133 11709trade USP Chapter lt1072gt Disinfectants and Antiseptics

Propionibacterium acnes Ge983154ath 11827trade EP 2627 Microbiological Control of Cellular Products

Pseudomonas aeruginosa PRD-10 15442trade USP Chapter lt1072gt Disinfectants and Antiseptics

Pseudomonas aeruginosa 25619trade USP Chapter lt81gt Antibiotics ndash Microbial Assays USP 37-NF32 2014


EP 513 Efficacy of antimicrobial prese983154vation EP 261 Sterility EP 2627 Microbiological Controlof Cellular Products EP 2613 Microbial examination of non-sterile products Test for SpecifiedMicro-organisms EP 2631 Microbiological Examination of Herbal Medicinal Products for O983154alUse EP Monog983154aphs Water for Injections EP Monog983154aphs Water for Prepa983154ation of Ext983154actsEP Monog983154aphs Water Highly Purified EP Monog983154aphs Water Purified USP 37 ChondroitinSulfate Sodium USP Microbiological Examination of Nonsterile Products Test EP 2612 Microbialexamination of non-sterile products Microbial Enume983154ation Tests EP 2613 Microbial examination

of non-sterile products Test for Specified Micro-organisms USP Microbiological Examinationof Nonsterile Products Tests for Specified Microorganisms lt62gt USP 37 Microbial limit tests ndashDieta983154y supplements - Prepa983154ato983154y testing Growth Promotion Testing lt2021gt lt51gt AntimicrobialEffectiveness Testing USP 37-NF32 2014 USP 37 Microbiological Examination of NonsterileProducts Microbial Enume983154ation Tests lt61gt USP 37 Microbiological Examination of NonsterileProducts Tests for Specified Microorganisms lt62gt lt71gt Sterility Tests USP 37-NF32 2014 JP 16405 I Microbiological Examination of Non-Sterile Products Total Viable Aerobic Count JP 16 405 IIMicrobiological Examination of Non-Sterile Products Tests for Specified Micro-Organisms JP 16 406Sterility Test JP 16 G4 Microorganisms Prese983154vatives-Effectiveness Tests JP 16 G8 Quality Control ofWater for Pharmaceutical Use

Pseudomonas protegens 1 17386trade JP 16 G8 Quality Control of Water for Pharmaceutical Use

Saccharomyces cerevisiae 2601trade USP Chapter lt81gt Antibiotics ndash Microbial Assays USP 37-NF32 2014

Saccharomyces cerevisiae NRRL Y-567 9763tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 Amphotericin B Nystatin

Sa983148monella enterica subsp enterica 13311tradeUSP Microbial limit tests ndash Dieta983154y supplements - Prepa983154ato983154y testing Growth Promotion Testing

lt2021gt

Sa983148monella enterica subsp enterica serovarTyphimurium CDC 6516-60

14028tradeEP 2613 Microbial examination of non-sterile products Test for Specified Micro-organisms EP2631 Microbiological Examination of Herbal Medicinal Products USP Chapter lt62gt MicrobiologicalExamination of Nonsterile Products JP16 405 II Microbiological Examination of Nonsterile Products

Sa983148monella enterica subsp enterica serovarAbony

BAA-2162tradeUSP Chapter lt62gt Microbiological examination of non-sterile products tests for specifiedmicroorganisms

Ser983154atia marcescens PCI 1107 14756trade USP Chapter lt1211gt Sterilization and sterility assu983154ance of compendial a983154ticles USP 37-NF32 2014

Staphylococcus aureus subsp aureus PCI1209N

12692trade Penicillin G Procaine and Novobiocin Sodium Int983154amamma983154y Infusion USP 37-NF32 2014

Staphylococcus aureus subsp aureus FDA 29737tradeUSP Chapter lt81gt Antibiotics ndash Microbial Assays USP 37-NF32 2014 USP 37 Tet983154acyclineHydrochloride and Novobiocin Sodium Tablets

Staphylococcus aureus subsp aureus 3R7089st983154ain Oxford

9144tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial Assays USP37-NF32 2014






EP 261 Sterility testing EP 2627 Microbiological Control of Cellular Products EP 272Microbiological assays of antibiotics EP 2612 Microbial examination of non-sterile productsMicrobial Enume983154ation Tests EP 2613 Microbial examination of non-sterile products Test forSpecified Micro-organisms EP 2631 Microbiological Examination of Herbal Medicinal Productsfor O983154al Use USP 37 Disinfectants and Antiseptics lt1072gt USP 37 Microbial limit tests ndash Dieta983154ysupplements - Prepa983154ato983154y testing Growth Promotion Testing lt2021gt lt51gt AntimicrobialEffectiveness Testing USP 37-NF32 2014 USP 37 Microbiological Examination of NonsterileProducts Microbial Enume983154ation Tests lt61gt USP 37 Microbiological Examination of Nonsterile

Products Tests for Specified Microorganisms lt62gt lt71gt Sterility Tests USP 37-NF32 2014 JP 16405 I Microbiological Examination of Non-Sterile Products Total Viable Aerobic Count JP 16 405II Microbiological Examination of Non-Sterile Products Tests for Specified Micro-Organisms JP 16406 Sterility Test JP 16 502 Microbial Limit Test for Crude Drugs JP 16 Benzylpenicillin PotassiumE983154ythromycin E983154ythromycin Ethylsuccinate E983154ythromycin Lactobionate E983154ythromycin Stea983154ateF983154adiomycin Sulfate Sodium fusidate JP 16 G4 Microorganisms Prese983154vatives-Effectiveness Tests JP16 G8 Quality Control of Water for Pharmaceutical Use

Staphylococcus epidermidis FDA st983154ain PCI1200

12228tradeEP 272 Microbiological assays of antibiotics USP Chapter lt81gt Antibiotics ndash Microbial AssaysUSP 37-NF32 2014 JP 16 Gentamycin Sulfate

Streptococcus pyogenes Bruno 19615trade EP 2627 Microbiological Control of Cellular Products

Yersinia enteroco983148itica subsp enteroco983148itica33114

9610trade EP 2627 Microbiological Control of Cellular Products

Please visit our website wwwatccorgpharmaceutical for more resources to help you in your pharmaceutical-related research applications

ATCC QUALITY CONTROL STANDARDSSearch our quality control page at wwwatccorgqc for st983154ains that are organized by procedu983154al standards and commercial identificationsystems

bull Standards from organizations and agencies such as CLSI ASTM International USP USDA FDA AOAC and BSI-Global

bull Commercial identification systems from companies including bioMeacuterieux Biolog Siemens DuPont Nutrition and Health and others

ATCC RELATED PRODUCTS

Value-added microbial reagents such as our microbial freeze media and supplements as well as nucleic acids offer convenience whilesaving time and money

bull Mycoplasma Growth Supplement (ATCCreg No 20-2206 and 20-2207) and TSB with 10 glycerol (ATCCreg No 20-2200)

bull Genomic DNA and RNA from well-cha983154acterized and authenticated microbial st983154ains

Convenient Tools for Quality ControlDeveloped by the leaders in microbial cultivation and prese983154vation ATCCreg Minisprovide a convenient ready-to-use solution for handling quality control st983154ains Eachglass-free tube contains a ready-to-use st983154ain in glycerol stock with a 2D barcode fo

easy t983154acking and peel-off labels for reliable recordkeeping It is easy to ensure thequality of your products with ATCCreg Minis ndash just open plate and go Visit us online atwwwatccorgminis to browse our collection



Find additional resources at wwwatccorgpharmaceutical

BA-0315-06

copy 2015 American Type Culture Collection The ATCC t983154ademark and t983154ade name any and all ATCC catalog numbers and any other t983154ademarks listed in this publication are t983154ademarks

of the American Type Culture Collection unless indicated othe983154wiseThese products are for labo983154ato983154y use only Not for human or diagnostic use ATCC products may not be resold modified for resale used to provide commercial se983154vices or tomanufacture commercial products without prior ATCC written approval

Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg

Or contact your local distributor



Table of Contents

Pharmaceutical Microbiology 1

St983154ains specified by official microbial assays 2United States Pharmacopeia (USP) 2European Pharmacopeia (EP) Edition 81 5 Japanese Pharmacopeia (JP) 7

St983154ains listed by genus and species 10

ATCC provides research and development tools and reagents as well as relatedbiological material management se983154vices consistent with its mission toacquire authenticate prese983154ve develop and distribute standard referencemicroorganisms cell lines and related materials for research in the life sciences

For over 85 years ATCC has been a leading

provider of high-quality biological materialsand standards to the life science communityWe are an independent 501(c)(3) non-profitentity focused on scientific enablement atuniversities research institutes governmentagencies and commercial research labsOur diverse and comprehensive resourcesin cell biology and microbiology have beencent983154al to the growth of the biotechnologyage ATCC has as its core mission to source

authenticate and fu983154ther develop products

and se983154vices essential to the needs of basicand applied life science work

ATCC distributes to more than 165countries on 6 continents and has a growinginternational network of 12 distributionpa983154tners Our inf983154astructure and experiencein biological materials logistics enables us towork effectively with researchers no mattewhere they are located

THE ESSENTIALS

OF LIFE SCIENCE

RESEARCH

GLOBALLY

DELIVEREDtrade






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EP 261 STERIL ITY







EP 267 MYCOPLAS MAS
















































































































































































































































































































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BA-0315-06



Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg







bull



































































































































































EP 261 STERIL ITY







EP 267 MYCOPLAS MAS
















































































































































































































































































































lt2021gt




































BA-0315-06



Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg



























































































































































EP 261 STERIL ITY







EP 267 MYCOPLAS MAS
















































































































































































































































































































lt2021gt




































BA-0315-06



Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg












































































































































































































































































lt2021gt




































BA-0315-06



Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg



























BA-0315-06



Tel 8006386597

7033652700

Fax 7033652750

Email salesatccorg

Web wwwatccorg


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