dietary supplements compendium - usp...let your voice be heard! please join us on may 15 for the...
TRANSCRIPT
New Online Dietary Supplements Compendium Coming SoonDietary Supplements Compendium 2019 Edition
To align with user needs and expectations the Dietary Supplements Compendium (DSC) 2019 Editionwill be an online platform similar to the USPshyNF Online The redesigned intuitive interface will giveusers access to the most comprehensive collection of quality standards for dietary supplementsClick here for more details
The new edition of the DSC will be available summer of 2019 Please check back and sign up for the latestinformation about upcoming enhancements and availability
In addition to selected new and revised monographs and General Chapters from the USPshyNF and Food ChemicalsCodex issued over the last three years the DSC 2019 will feature
72 new monographs24 additional General Chapters59 new updated and supplementary sets of HighshyPerformance ThinshyLayer Chromatographic (HPLC) datafor the botanical monographs in full color and high resolution24 new and 45 revised Admission Evaluations documents21 new and 12 revised sets of data in support of the dietary supplement monographs with dozens of newchromatograms and color photomicrographsA new edition of the USP Dietary Supplements Verification Program (DSVP) manualRevised and updated dietary intake comparison tablesNew and updated guidance documents contributed by dietary supplements industry associationsAn extensive collection of FDA documents relevant to the dietary supplements industry
USP Dietary Supplements Verification Program on ldquoCBS This MorningrdquoOn February 22 2019 USP was highlighted by Dr David Agnus in a segment on CBS This Morning
Dr Agnus discussed supplement regulation and recommended consumers look for the USP Verifiedmark to ensure they are getting a quality supplement View the full segment and learn why the USPVerified Mark is important to health
Americans spent more than $40 billion on supplements last yearand three out of four Americans regularly take a supplement TheFDA plans to strengthen its oversight of the dietary supplementmarket This is an important development and USP is a leadingchange agent to help ensure quality supplements
For more information visit wwwUSPverifiedorg
Upcoming Events and Meetings
Products and Services
New Dietary SupplementsReference Standards
Below is a list of newly releasedreference standards
Herbal Medicines Botanical DietarySupplements
NegundosideVitex negundo Leaf Dry ExtractBaicaleinBaicalein 7shyOshyGlucuronideScutellaria Baicalensis Root DryExtract
NonshyBotanicals
Docosahexaenoic AcidEicosapentaenoic Acid Omegashy3 Free Fatty AcidsLshyalphashyGlycerophosphorylethanolamineLshyalphashyGlycerylphosphorylcholinebetashyGlycerylphosphorylcholine
Monographs
Standards Open for PublicComment until May 31 2019
The standards below werepublished in PF 45(2) for publiccomments on March 1 2019 andwill receive and considerfeedback until May 31 2019 Tocomment please visit USPshyNFPharmacopeial Forum
New MonographsGeneral Chapters
CiticolineOilshy and watershysoluble vitaminswith minerals Chewable Gels
Revised MonographsGeneralChapters
Saw Palmetto CapsulesSaw Palmetto ExtractLactase
Let your voice be heard
Please join us on May 15 for the Dietary Supplements Stakeholder Forum onshysite or online This is a free event andUSP encourages manufacturers organizations service providers and other interested parties who work with dietarysupplements to attend share perspectives and provide direct feedback on priority standards issues Stakeholdertopics submitted so far include hemp pesticide residues food allergens and label content claims Click here to viewagenda and for more details Register Today
Past Events
Botanical NonshyBotanical and Joint Dietary Supplements Expert Committee Annual Meetings March 26shy28 2019 | Rockville MD
The Botanical Dietary Supplements and Herbal Medicines Expert Committee (BDSHM EC) and NonshyBotanicalDietary Supplements Expert Committee (NBDS EC) had their annual joint faceshytoshyface meetings at USPrsquos Rockvillesite this past March In their separate meetings the ECs received updates from their Expert Panels andSubcommittees reviewed upcoming ballot items for USP43shyNF38 and received updates on other ongoing projects
In their joint meeting they received updates from Joint Subcommittees discussed topics of mutual interest andreceived updates from USP staff The Chair and Vice Chair from the Food Ingredients Expert Committee alsoattended and led discussions on ongoing and potential collaborative activities between the Foods and DietarySupplements groups Executive Summaries from these meetings are scheduled to be posted to the ECrsquosrespective work plan pages on USPorg by midshyMay
Expert Committee Work Plan for Botanical Dietary Supplements andExpert Committee Work Plan for NonshyBotanical Dietary Supplements
Natural Products Expo West
March 5 ndash 9 2019 | Anaheim California
About 86000 natural ingredient and product suppliers descended upon the Anaheim Convention Center in March forNatural Products Expo West Products that were of particular interest at the show included HempCBD andprobiotics Discussions about potential changes to DSHEA the regulatorylegal status of CBDshycontaining productsthe definition of nonshyGMO and synthetic biology were held during the scientific sessions USP experts met withattendees and responded to questions about monographs sponsoring monographs dietary ingredient and dietarysupplement verification programs and GMP audits
Be Part of the Standards Development ProcessHelp shape standards specifications and test methods by sponsoring monographs or general chapters and theirsupporting Reference Standards USP doesnrsquot charge fees to develop monographs ndash all you need is a willingness tocollaborate with us to help safeguard the supply chain for supplements and ingredients USP standards for dietaryingredients and dietary supplements are a resource for public specifications and scientifically valid methods that canhelp in GMP compliance and in safeguarding the supply chain for supplements and ingredients USP is seekingdonations for the following monographs
NonshyBotanical Dietary Supplement Ingredients
Undenatured Collagen Type IIGlucoronolactoneGamma amino butyric acid (GABA)KeratinBifidobacterium InfantisLactobacillus plantarum 299vLutein estersLshyOrnithinePantethine
Reference Standards Coming Soon
Botanicals
Bitter Orange FruitFlavonoid Dry ExtractCoptis chinensis RhizomeDry ExtractCoptisine ChlorideEpicatechinGuarana Seed Dry ExtractProcyanidin B2
NonshyBotanicals
Annatto Seed TocotrienolsExtractbetashyGlycerylphosphorylcholineHydroxocobalamin Chloride
Standards Open for PublicComment until September 312019
The standards below will bepublished in PF 45(4) for publiccomment on July 1 2019 and willreceive and consider feedbackuntil September 31 2019 Tocomment please visit USPshyNFPharmacopeial Forum
New MonographsGeneralChapters
Calcium Magnesium CitrateDshychiroshyInositolFish Oil Omegashy3 Acid EthylEsters ConcentratePummelo PeelPummelo Peel PowderPummelo Peel FlavonoidsDry Extract
Revised MonographsGeneralChapters
Asian Ginseng Root andRhizomeAsian Ginseng Root andRhizome PowderAsian Ginseng Root andRhizome Dry ExtractAmerican Ginseng Root andRhizomeAmerican Ginseng Root andRhizome PowderAmerican Ginseng Root andRhizome Dry Extract
_____________________________
New Monographs underDevelopment
Botanicals
Ajowan FruitAjowan Fruit PowderAjowan Fruit Dry ExtractBroccoli Seed Dry ExtractCranberry Fruit Juice DryExtract
Rice protein isolateSalmon OilZeaxanthin preparation
NonshyBotanical Dosage Forms (Finished Dietary Supplements)
Cyanocobalamin capsulesGlucosamine Chondroitin Sulfate Sodium capsulesMagnesium Citrate capsulesMenaquinone 4 tablets or capsulesMethylcobalamin orally disintegrating tabletsOmegashy3shyTriglyceride chewable gels (gummies)Plant Sterol tabletsSshyAdenosylshyLshyMethionine Disulfate Tosylate tablets
For more information on how to donate and a complete list of requested monographs please visit USP Dietary Supplements and Herbal Medicines Standards Development Process or contact
DietarySciStaffUSPorg
USP Admission Evaluations of Articles Prior to Monograph Development
Before a dietary ingredient is considered for the development of quality standards it must undergo aUSP Admission Evaluation performed by the USP Dietary Supplements Admission Evaluations JointStandard Setting Subcommittee (DSAE JS3) The DSAE JS3 reviews information related to theingredientrsquos safety relevance in the market regulatory status and presence in other pharmacopeiasand whether the article poses a serious health risk when used as a dietary supplement
If the article does not pose a serious health risk or poses a minor safety concern that can be mitigatedby a label caution statement in the monograph the article is placed in class A and is admitted formonograph development If the article poses a serious health risk it is placed in class B and is notadmitted for monograph development
The DSAE JS3 met via Webex on Tuesday March 19th 2019 to deliberate on Indian Barberry StemCoptis Species Rhizome and Terminalia chebula fruit Comments on the safety of these ingredients arewelcome
For more information please contact Hellen OketchshyRabah PhD at HAOusporg or Emily MaddenPhD at EmilyMaddenusporg
Nomenclature of Dietary Supplements
Updates from the Dietary Supplements and Herbal Medicines (DSHM) NomenclatureSubcommittee
DSHM Nom JSC met on February 26th 2019 and recommended the following monograph titles forapproval
Magnolia Species BarkMagnolia Species Bark PowderMoringa Leaf Dry Extract
DSHM Nom JSC is revising the Guideline for Assigning Titles to USP Dietary SupplementMonographs To view the Guideline click here Guideline for Assigning Titles to USP DietarySupplement Monographs This process will continue for the next 6 months Any comments on theguideline are welcome For more information on dietary supplements nomenclature please contactHellen OketchshyRabah PhD at HAOusporg
USP Answers Your QuestionsQ How are various Temperature and Storage conditions defined by USP
A Freezer A place in which the temperature is controlled between minus25deg and minus10deg (minus13deg and 14deg F) Itis noted that in some instances articles may have a recommended storage condition below minus20deg (minus4degF) In such cases the temperature of the storage location should be controlled to plusmn10deg
Refrigerator A cold place in which the temperature is controlled between 2deg and 8deg (36deg and 46deg F)
Cold Any temperature not exceeding 8deg (46deg F)
Cool Any temperature between 8deg and 15deg (46deg and 59deg F) [NotemdashAn article for which storage in acool place is directed may alternatively be stored and shipped as refrigerated unless otherwisespecified by the individual monograph]
Room temperature (also referred to as Ambient temperature) The temperature prevailing in a workingenvironment
Controlled room temperature The temperature maintained thermostatically that encompasses theusual and customary working environment of 20degndash25deg (68degndash77deg F) The following conditions also apply
Cranberry Fruit JuiceConcentrateCranberry Fruit Dry JuiceFeverfew leaf extractPomegranate Fruit DryExtractRed Clover TabletsSour Jujube SeedSour Jujube Seed DryExtractSour Jujube Seed PowderWhite Peony RootWhite Peony Root PowderWhite Peony Root DryExtract
NonshyBotanicals
3shyhydroxyshy3shymethylbutyricacid (HMB)Bifidobacterium bifidiuBifidobacterium longumsubsp longumCalcium 3shyhydroxyshy3shymethylbutyrateCholine CitrateHydrolyzed CollagenInositol NiacinateLactobacillus reuteriLactobacillus rhamnosusLutein EstersNative CollagenOilshy and watershysolubleVitamins PremixesOilshysoluble VitaminsPremixesOilshy and watershysolubleVitamins with MineralsChewable GelPhytosterol EstersPlant sterolsSshyAdenosylshyLshyMethionine14shyButanedisulfonateTocotrienolsWater Soluble VitaminsPremixesZeaxanthin Preparation
Reference Standards inDevelopment
Botanicals
Aegle marmelos Fruit DryExtractAngelica sinensis RootPowderBerberis aristata Stem DryExtractBroccoli Seed Dry ExtractChebulagic AcidChrysanthemum indicumFlower Dry ExtractChrysanthemum xmorifolium Flower DryExtractCitrus maxima PeelFlavonoids Dry ExtractCranberry Fruit Juice DryExtractCullen corylifolium Fruit DryExtractGinger Rhizome CarbonDioxide Soft ExtractGinsenoside Rb1GlucoraphaninIsochlorogenic Acid A
Mean kinetic temperature not to exceed 25deg Excursions between 15deg and 30deg (59deg and 86deg F)that are experienced in pharmacies hospitals and warehouses and during shipping are allowedProvided the mean kinetic temperature does not exceed 25deg transient spikes up to 40deg arepermitted if they do not exceed 24 h Spikes above 40deg may be permitted only if the manufacturerso instructsArticles may be labeled for storage at ldquocontrolled room temperaturerdquo or at ldquo20degndash25degrdquo or otherwording based on the same mean kinetic temperature [see also Good Storage and DistributionPractices for Drug Products lang1079rang Quality Management System Environmental ManagementSystem Mean Kinetic Temperature (MKT) Calculation]An article for which storage at Controlled room temperature is directed may alternatively bestored and shipped in a cool place or refrigerated unless otherwise specified in the individualmonograph or on the label
Warm Any temperature between 30deg and 40deg (86deg and 104deg F)
Excessive heat Any temperature above 40deg (104deg F)
Dry place A place that does not exceed 40 average relative humidity at 20deg (68deg F) or the equivalentwater vapor pressure at other temperatures The determination may be made by direct measurementat the place Determination is based on NLT 12 equally spaced measurements that encompass eithera season a year or where recorded data demonstrate the storage period of the article There may bevalues of up to 45 relative humidity provided that the average value does not exceed 40 relativehumidity Storage in a Container validated to protect the article from moisture vapor including storagein bulk is considered a Dry place
Protect from freezing The Container label will bear an appropriate instruction to protect the article fromfreezing in cases where freezing exposes an article to loss of strength or potency or to destructivealteration of its characteristics These risks are present in addition to the risk that the Container maybreak if exposed to freezing temperatures
Protect from light Where light subjects an article to loss of strength or potency or to destructivealteration of its characteristics the Container label bears an appropriate instruction to protect the articlefrom light The article must be packaged in a lightshyresistant Container
Isorhamnetinndash3ndashOndashRutinosideLigusticum chuanxiongRhizome PowderLinarinMaca rootMaca root extractMarmelosinPalmatine ChloridePomegranate Fruit DryExtractProcyanidin A2PunicalaginSenkyunolide ARhoifolinTerminalia chebula Fruit DryExtractZshyLigustilide
NonshyBotanicals
Calcium Magnesium CitrateCholine CitrateConjugated Linoleic AcidsshyshyTriglyceridesDshychiroshyInositolPinitolPyrroloquinoline quinoneLshyOrnithine HydrochlorideSshyAdenosylshyLshyMethionine14shyButanedisulfonate
Click here to Find aReference Standard
To Suggest a ReferenceStandard click here
Copyright copy 2019 All rights reserved
Our mailing address is United States Pharmacopeial
12601 Twinbrook Parkway | Rockville MD 20852-1790 Phone +1-301-881-0666 or 00-800-4875-5555 (select Europe)
USPorg | Contact Us | Privacy Statements
Update Your Subscription Preferences | Unsubscribe from All emails
Let your voice be heard
Please join us on May 15 for the Dietary Supplements Stakeholder Forum onshysite or online This is a free event andUSP encourages manufacturers organizations service providers and other interested parties who work with dietarysupplements to attend share perspectives and provide direct feedback on priority standards issues Stakeholdertopics submitted so far include hemp pesticide residues food allergens and label content claims Click here to viewagenda and for more details Register Today
Past Events
Botanical NonshyBotanical and Joint Dietary Supplements Expert Committee Annual Meetings March 26shy28 2019 | Rockville MD
The Botanical Dietary Supplements and Herbal Medicines Expert Committee (BDSHM EC) and NonshyBotanicalDietary Supplements Expert Committee (NBDS EC) had their annual joint faceshytoshyface meetings at USPrsquos Rockvillesite this past March In their separate meetings the ECs received updates from their Expert Panels andSubcommittees reviewed upcoming ballot items for USP43shyNF38 and received updates on other ongoing projects
In their joint meeting they received updates from Joint Subcommittees discussed topics of mutual interest andreceived updates from USP staff The Chair and Vice Chair from the Food Ingredients Expert Committee alsoattended and led discussions on ongoing and potential collaborative activities between the Foods and DietarySupplements groups Executive Summaries from these meetings are scheduled to be posted to the ECrsquosrespective work plan pages on USPorg by midshyMay
Expert Committee Work Plan for Botanical Dietary Supplements andExpert Committee Work Plan for NonshyBotanical Dietary Supplements
Natural Products Expo West
March 5 ndash 9 2019 | Anaheim California
About 86000 natural ingredient and product suppliers descended upon the Anaheim Convention Center in March forNatural Products Expo West Products that were of particular interest at the show included HempCBD andprobiotics Discussions about potential changes to DSHEA the regulatorylegal status of CBDshycontaining productsthe definition of nonshyGMO and synthetic biology were held during the scientific sessions USP experts met withattendees and responded to questions about monographs sponsoring monographs dietary ingredient and dietarysupplement verification programs and GMP audits
Be Part of the Standards Development ProcessHelp shape standards specifications and test methods by sponsoring monographs or general chapters and theirsupporting Reference Standards USP doesnrsquot charge fees to develop monographs ndash all you need is a willingness tocollaborate with us to help safeguard the supply chain for supplements and ingredients USP standards for dietaryingredients and dietary supplements are a resource for public specifications and scientifically valid methods that canhelp in GMP compliance and in safeguarding the supply chain for supplements and ingredients USP is seekingdonations for the following monographs
NonshyBotanical Dietary Supplement Ingredients
Undenatured Collagen Type IIGlucoronolactoneGamma amino butyric acid (GABA)KeratinBifidobacterium InfantisLactobacillus plantarum 299vLutein estersLshyOrnithinePantethine
Reference Standards Coming Soon
Botanicals
Bitter Orange FruitFlavonoid Dry ExtractCoptis chinensis RhizomeDry ExtractCoptisine ChlorideEpicatechinGuarana Seed Dry ExtractProcyanidin B2
NonshyBotanicals
Annatto Seed TocotrienolsExtractbetashyGlycerylphosphorylcholineHydroxocobalamin Chloride
Standards Open for PublicComment until September 312019
The standards below will bepublished in PF 45(4) for publiccomment on July 1 2019 and willreceive and consider feedbackuntil September 31 2019 Tocomment please visit USPshyNFPharmacopeial Forum
New MonographsGeneralChapters
Calcium Magnesium CitrateDshychiroshyInositolFish Oil Omegashy3 Acid EthylEsters ConcentratePummelo PeelPummelo Peel PowderPummelo Peel FlavonoidsDry Extract
Revised MonographsGeneralChapters
Asian Ginseng Root andRhizomeAsian Ginseng Root andRhizome PowderAsian Ginseng Root andRhizome Dry ExtractAmerican Ginseng Root andRhizomeAmerican Ginseng Root andRhizome PowderAmerican Ginseng Root andRhizome Dry Extract
_____________________________
New Monographs underDevelopment
Botanicals
Ajowan FruitAjowan Fruit PowderAjowan Fruit Dry ExtractBroccoli Seed Dry ExtractCranberry Fruit Juice DryExtract
Rice protein isolateSalmon OilZeaxanthin preparation
NonshyBotanical Dosage Forms (Finished Dietary Supplements)
Cyanocobalamin capsulesGlucosamine Chondroitin Sulfate Sodium capsulesMagnesium Citrate capsulesMenaquinone 4 tablets or capsulesMethylcobalamin orally disintegrating tabletsOmegashy3shyTriglyceride chewable gels (gummies)Plant Sterol tabletsSshyAdenosylshyLshyMethionine Disulfate Tosylate tablets
For more information on how to donate and a complete list of requested monographs please visit USP Dietary Supplements and Herbal Medicines Standards Development Process or contact
DietarySciStaffUSPorg
USP Admission Evaluations of Articles Prior to Monograph Development
Before a dietary ingredient is considered for the development of quality standards it must undergo aUSP Admission Evaluation performed by the USP Dietary Supplements Admission Evaluations JointStandard Setting Subcommittee (DSAE JS3) The DSAE JS3 reviews information related to theingredientrsquos safety relevance in the market regulatory status and presence in other pharmacopeiasand whether the article poses a serious health risk when used as a dietary supplement
If the article does not pose a serious health risk or poses a minor safety concern that can be mitigatedby a label caution statement in the monograph the article is placed in class A and is admitted formonograph development If the article poses a serious health risk it is placed in class B and is notadmitted for monograph development
The DSAE JS3 met via Webex on Tuesday March 19th 2019 to deliberate on Indian Barberry StemCoptis Species Rhizome and Terminalia chebula fruit Comments on the safety of these ingredients arewelcome
For more information please contact Hellen OketchshyRabah PhD at HAOusporg or Emily MaddenPhD at EmilyMaddenusporg
Nomenclature of Dietary Supplements
Updates from the Dietary Supplements and Herbal Medicines (DSHM) NomenclatureSubcommittee
DSHM Nom JSC met on February 26th 2019 and recommended the following monograph titles forapproval
Magnolia Species BarkMagnolia Species Bark PowderMoringa Leaf Dry Extract
DSHM Nom JSC is revising the Guideline for Assigning Titles to USP Dietary SupplementMonographs To view the Guideline click here Guideline for Assigning Titles to USP DietarySupplement Monographs This process will continue for the next 6 months Any comments on theguideline are welcome For more information on dietary supplements nomenclature please contactHellen OketchshyRabah PhD at HAOusporg
USP Answers Your QuestionsQ How are various Temperature and Storage conditions defined by USP
A Freezer A place in which the temperature is controlled between minus25deg and minus10deg (minus13deg and 14deg F) Itis noted that in some instances articles may have a recommended storage condition below minus20deg (minus4degF) In such cases the temperature of the storage location should be controlled to plusmn10deg
Refrigerator A cold place in which the temperature is controlled between 2deg and 8deg (36deg and 46deg F)
Cold Any temperature not exceeding 8deg (46deg F)
Cool Any temperature between 8deg and 15deg (46deg and 59deg F) [NotemdashAn article for which storage in acool place is directed may alternatively be stored and shipped as refrigerated unless otherwisespecified by the individual monograph]
Room temperature (also referred to as Ambient temperature) The temperature prevailing in a workingenvironment
Controlled room temperature The temperature maintained thermostatically that encompasses theusual and customary working environment of 20degndash25deg (68degndash77deg F) The following conditions also apply
Cranberry Fruit JuiceConcentrateCranberry Fruit Dry JuiceFeverfew leaf extractPomegranate Fruit DryExtractRed Clover TabletsSour Jujube SeedSour Jujube Seed DryExtractSour Jujube Seed PowderWhite Peony RootWhite Peony Root PowderWhite Peony Root DryExtract
NonshyBotanicals
3shyhydroxyshy3shymethylbutyricacid (HMB)Bifidobacterium bifidiuBifidobacterium longumsubsp longumCalcium 3shyhydroxyshy3shymethylbutyrateCholine CitrateHydrolyzed CollagenInositol NiacinateLactobacillus reuteriLactobacillus rhamnosusLutein EstersNative CollagenOilshy and watershysolubleVitamins PremixesOilshysoluble VitaminsPremixesOilshy and watershysolubleVitamins with MineralsChewable GelPhytosterol EstersPlant sterolsSshyAdenosylshyLshyMethionine14shyButanedisulfonateTocotrienolsWater Soluble VitaminsPremixesZeaxanthin Preparation
Reference Standards inDevelopment
Botanicals
Aegle marmelos Fruit DryExtractAngelica sinensis RootPowderBerberis aristata Stem DryExtractBroccoli Seed Dry ExtractChebulagic AcidChrysanthemum indicumFlower Dry ExtractChrysanthemum xmorifolium Flower DryExtractCitrus maxima PeelFlavonoids Dry ExtractCranberry Fruit Juice DryExtractCullen corylifolium Fruit DryExtractGinger Rhizome CarbonDioxide Soft ExtractGinsenoside Rb1GlucoraphaninIsochlorogenic Acid A
Mean kinetic temperature not to exceed 25deg Excursions between 15deg and 30deg (59deg and 86deg F)that are experienced in pharmacies hospitals and warehouses and during shipping are allowedProvided the mean kinetic temperature does not exceed 25deg transient spikes up to 40deg arepermitted if they do not exceed 24 h Spikes above 40deg may be permitted only if the manufacturerso instructsArticles may be labeled for storage at ldquocontrolled room temperaturerdquo or at ldquo20degndash25degrdquo or otherwording based on the same mean kinetic temperature [see also Good Storage and DistributionPractices for Drug Products lang1079rang Quality Management System Environmental ManagementSystem Mean Kinetic Temperature (MKT) Calculation]An article for which storage at Controlled room temperature is directed may alternatively bestored and shipped in a cool place or refrigerated unless otherwise specified in the individualmonograph or on the label
Warm Any temperature between 30deg and 40deg (86deg and 104deg F)
Excessive heat Any temperature above 40deg (104deg F)
Dry place A place that does not exceed 40 average relative humidity at 20deg (68deg F) or the equivalentwater vapor pressure at other temperatures The determination may be made by direct measurementat the place Determination is based on NLT 12 equally spaced measurements that encompass eithera season a year or where recorded data demonstrate the storage period of the article There may bevalues of up to 45 relative humidity provided that the average value does not exceed 40 relativehumidity Storage in a Container validated to protect the article from moisture vapor including storagein bulk is considered a Dry place
Protect from freezing The Container label will bear an appropriate instruction to protect the article fromfreezing in cases where freezing exposes an article to loss of strength or potency or to destructivealteration of its characteristics These risks are present in addition to the risk that the Container maybreak if exposed to freezing temperatures
Protect from light Where light subjects an article to loss of strength or potency or to destructivealteration of its characteristics the Container label bears an appropriate instruction to protect the articlefrom light The article must be packaged in a lightshyresistant Container
Isorhamnetinndash3ndashOndashRutinosideLigusticum chuanxiongRhizome PowderLinarinMaca rootMaca root extractMarmelosinPalmatine ChloridePomegranate Fruit DryExtractProcyanidin A2PunicalaginSenkyunolide ARhoifolinTerminalia chebula Fruit DryExtractZshyLigustilide
NonshyBotanicals
Calcium Magnesium CitrateCholine CitrateConjugated Linoleic AcidsshyshyTriglyceridesDshychiroshyInositolPinitolPyrroloquinoline quinoneLshyOrnithine HydrochlorideSshyAdenosylshyLshyMethionine14shyButanedisulfonate
Click here to Find aReference Standard
To Suggest a ReferenceStandard click here
Copyright copy 2019 All rights reserved
Our mailing address is United States Pharmacopeial
12601 Twinbrook Parkway | Rockville MD 20852-1790 Phone +1-301-881-0666 or 00-800-4875-5555 (select Europe)
USPorg | Contact Us | Privacy Statements
Update Your Subscription Preferences | Unsubscribe from All emails
Rice protein isolateSalmon OilZeaxanthin preparation
NonshyBotanical Dosage Forms (Finished Dietary Supplements)
Cyanocobalamin capsulesGlucosamine Chondroitin Sulfate Sodium capsulesMagnesium Citrate capsulesMenaquinone 4 tablets or capsulesMethylcobalamin orally disintegrating tabletsOmegashy3shyTriglyceride chewable gels (gummies)Plant Sterol tabletsSshyAdenosylshyLshyMethionine Disulfate Tosylate tablets
For more information on how to donate and a complete list of requested monographs please visit USP Dietary Supplements and Herbal Medicines Standards Development Process or contact
DietarySciStaffUSPorg
USP Admission Evaluations of Articles Prior to Monograph Development
Before a dietary ingredient is considered for the development of quality standards it must undergo aUSP Admission Evaluation performed by the USP Dietary Supplements Admission Evaluations JointStandard Setting Subcommittee (DSAE JS3) The DSAE JS3 reviews information related to theingredientrsquos safety relevance in the market regulatory status and presence in other pharmacopeiasand whether the article poses a serious health risk when used as a dietary supplement
If the article does not pose a serious health risk or poses a minor safety concern that can be mitigatedby a label caution statement in the monograph the article is placed in class A and is admitted formonograph development If the article poses a serious health risk it is placed in class B and is notadmitted for monograph development
The DSAE JS3 met via Webex on Tuesday March 19th 2019 to deliberate on Indian Barberry StemCoptis Species Rhizome and Terminalia chebula fruit Comments on the safety of these ingredients arewelcome
For more information please contact Hellen OketchshyRabah PhD at HAOusporg or Emily MaddenPhD at EmilyMaddenusporg
Nomenclature of Dietary Supplements
Updates from the Dietary Supplements and Herbal Medicines (DSHM) NomenclatureSubcommittee
DSHM Nom JSC met on February 26th 2019 and recommended the following monograph titles forapproval
Magnolia Species BarkMagnolia Species Bark PowderMoringa Leaf Dry Extract
DSHM Nom JSC is revising the Guideline for Assigning Titles to USP Dietary SupplementMonographs To view the Guideline click here Guideline for Assigning Titles to USP DietarySupplement Monographs This process will continue for the next 6 months Any comments on theguideline are welcome For more information on dietary supplements nomenclature please contactHellen OketchshyRabah PhD at HAOusporg
USP Answers Your QuestionsQ How are various Temperature and Storage conditions defined by USP
A Freezer A place in which the temperature is controlled between minus25deg and minus10deg (minus13deg and 14deg F) Itis noted that in some instances articles may have a recommended storage condition below minus20deg (minus4degF) In such cases the temperature of the storage location should be controlled to plusmn10deg
Refrigerator A cold place in which the temperature is controlled between 2deg and 8deg (36deg and 46deg F)
Cold Any temperature not exceeding 8deg (46deg F)
Cool Any temperature between 8deg and 15deg (46deg and 59deg F) [NotemdashAn article for which storage in acool place is directed may alternatively be stored and shipped as refrigerated unless otherwisespecified by the individual monograph]
Room temperature (also referred to as Ambient temperature) The temperature prevailing in a workingenvironment
Controlled room temperature The temperature maintained thermostatically that encompasses theusual and customary working environment of 20degndash25deg (68degndash77deg F) The following conditions also apply
Cranberry Fruit JuiceConcentrateCranberry Fruit Dry JuiceFeverfew leaf extractPomegranate Fruit DryExtractRed Clover TabletsSour Jujube SeedSour Jujube Seed DryExtractSour Jujube Seed PowderWhite Peony RootWhite Peony Root PowderWhite Peony Root DryExtract
NonshyBotanicals
3shyhydroxyshy3shymethylbutyricacid (HMB)Bifidobacterium bifidiuBifidobacterium longumsubsp longumCalcium 3shyhydroxyshy3shymethylbutyrateCholine CitrateHydrolyzed CollagenInositol NiacinateLactobacillus reuteriLactobacillus rhamnosusLutein EstersNative CollagenOilshy and watershysolubleVitamins PremixesOilshysoluble VitaminsPremixesOilshy and watershysolubleVitamins with MineralsChewable GelPhytosterol EstersPlant sterolsSshyAdenosylshyLshyMethionine14shyButanedisulfonateTocotrienolsWater Soluble VitaminsPremixesZeaxanthin Preparation
Reference Standards inDevelopment
Botanicals
Aegle marmelos Fruit DryExtractAngelica sinensis RootPowderBerberis aristata Stem DryExtractBroccoli Seed Dry ExtractChebulagic AcidChrysanthemum indicumFlower Dry ExtractChrysanthemum xmorifolium Flower DryExtractCitrus maxima PeelFlavonoids Dry ExtractCranberry Fruit Juice DryExtractCullen corylifolium Fruit DryExtractGinger Rhizome CarbonDioxide Soft ExtractGinsenoside Rb1GlucoraphaninIsochlorogenic Acid A
Mean kinetic temperature not to exceed 25deg Excursions between 15deg and 30deg (59deg and 86deg F)that are experienced in pharmacies hospitals and warehouses and during shipping are allowedProvided the mean kinetic temperature does not exceed 25deg transient spikes up to 40deg arepermitted if they do not exceed 24 h Spikes above 40deg may be permitted only if the manufacturerso instructsArticles may be labeled for storage at ldquocontrolled room temperaturerdquo or at ldquo20degndash25degrdquo or otherwording based on the same mean kinetic temperature [see also Good Storage and DistributionPractices for Drug Products lang1079rang Quality Management System Environmental ManagementSystem Mean Kinetic Temperature (MKT) Calculation]An article for which storage at Controlled room temperature is directed may alternatively bestored and shipped in a cool place or refrigerated unless otherwise specified in the individualmonograph or on the label
Warm Any temperature between 30deg and 40deg (86deg and 104deg F)
Excessive heat Any temperature above 40deg (104deg F)
Dry place A place that does not exceed 40 average relative humidity at 20deg (68deg F) or the equivalentwater vapor pressure at other temperatures The determination may be made by direct measurementat the place Determination is based on NLT 12 equally spaced measurements that encompass eithera season a year or where recorded data demonstrate the storage period of the article There may bevalues of up to 45 relative humidity provided that the average value does not exceed 40 relativehumidity Storage in a Container validated to protect the article from moisture vapor including storagein bulk is considered a Dry place
Protect from freezing The Container label will bear an appropriate instruction to protect the article fromfreezing in cases where freezing exposes an article to loss of strength or potency or to destructivealteration of its characteristics These risks are present in addition to the risk that the Container maybreak if exposed to freezing temperatures
Protect from light Where light subjects an article to loss of strength or potency or to destructivealteration of its characteristics the Container label bears an appropriate instruction to protect the articlefrom light The article must be packaged in a lightshyresistant Container
Isorhamnetinndash3ndashOndashRutinosideLigusticum chuanxiongRhizome PowderLinarinMaca rootMaca root extractMarmelosinPalmatine ChloridePomegranate Fruit DryExtractProcyanidin A2PunicalaginSenkyunolide ARhoifolinTerminalia chebula Fruit DryExtractZshyLigustilide
NonshyBotanicals
Calcium Magnesium CitrateCholine CitrateConjugated Linoleic AcidsshyshyTriglyceridesDshychiroshyInositolPinitolPyrroloquinoline quinoneLshyOrnithine HydrochlorideSshyAdenosylshyLshyMethionine14shyButanedisulfonate
Click here to Find aReference Standard
To Suggest a ReferenceStandard click here
Copyright copy 2019 All rights reserved
Our mailing address is United States Pharmacopeial
12601 Twinbrook Parkway | Rockville MD 20852-1790 Phone +1-301-881-0666 or 00-800-4875-5555 (select Europe)
USPorg | Contact Us | Privacy Statements
Update Your Subscription Preferences | Unsubscribe from All emails
Mean kinetic temperature not to exceed 25deg Excursions between 15deg and 30deg (59deg and 86deg F)that are experienced in pharmacies hospitals and warehouses and during shipping are allowedProvided the mean kinetic temperature does not exceed 25deg transient spikes up to 40deg arepermitted if they do not exceed 24 h Spikes above 40deg may be permitted only if the manufacturerso instructsArticles may be labeled for storage at ldquocontrolled room temperaturerdquo or at ldquo20degndash25degrdquo or otherwording based on the same mean kinetic temperature [see also Good Storage and DistributionPractices for Drug Products lang1079rang Quality Management System Environmental ManagementSystem Mean Kinetic Temperature (MKT) Calculation]An article for which storage at Controlled room temperature is directed may alternatively bestored and shipped in a cool place or refrigerated unless otherwise specified in the individualmonograph or on the label
Warm Any temperature between 30deg and 40deg (86deg and 104deg F)
Excessive heat Any temperature above 40deg (104deg F)
Dry place A place that does not exceed 40 average relative humidity at 20deg (68deg F) or the equivalentwater vapor pressure at other temperatures The determination may be made by direct measurementat the place Determination is based on NLT 12 equally spaced measurements that encompass eithera season a year or where recorded data demonstrate the storage period of the article There may bevalues of up to 45 relative humidity provided that the average value does not exceed 40 relativehumidity Storage in a Container validated to protect the article from moisture vapor including storagein bulk is considered a Dry place
Protect from freezing The Container label will bear an appropriate instruction to protect the article fromfreezing in cases where freezing exposes an article to loss of strength or potency or to destructivealteration of its characteristics These risks are present in addition to the risk that the Container maybreak if exposed to freezing temperatures
Protect from light Where light subjects an article to loss of strength or potency or to destructivealteration of its characteristics the Container label bears an appropriate instruction to protect the articlefrom light The article must be packaged in a lightshyresistant Container
Isorhamnetinndash3ndashOndashRutinosideLigusticum chuanxiongRhizome PowderLinarinMaca rootMaca root extractMarmelosinPalmatine ChloridePomegranate Fruit DryExtractProcyanidin A2PunicalaginSenkyunolide ARhoifolinTerminalia chebula Fruit DryExtractZshyLigustilide
NonshyBotanicals
Calcium Magnesium CitrateCholine CitrateConjugated Linoleic AcidsshyshyTriglyceridesDshychiroshyInositolPinitolPyrroloquinoline quinoneLshyOrnithine HydrochlorideSshyAdenosylshyLshyMethionine14shyButanedisulfonate
Click here to Find aReference Standard
To Suggest a ReferenceStandard click here
Copyright copy 2019 All rights reserved
Our mailing address is United States Pharmacopeial
12601 Twinbrook Parkway | Rockville MD 20852-1790 Phone +1-301-881-0666 or 00-800-4875-5555 (select Europe)
USPorg | Contact Us | Privacy Statements
Update Your Subscription Preferences | Unsubscribe from All emails