poly b dossier new

7/25/2019 Poly B Dossier New

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PRODUCT DOSSIER FOR THE

REGISTRATION OF PHARMACEUTICAL

PRODUCT IN NEPAL

POLY-B

(POLYMYXIN B SULPHATE INJECTION 500000 IU)

Submitted by :

SAMARTH LIFE SCIENCES PVT. LTD.

Nangal Ue!la" S#a!g$at R%ad" Nalaga!$"

Di&t.: S%lan 'H.P.(


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INDE)

Se*ti%nN%.

De&*!iti%n

1 Manufacturing License

2 COPP (Certificate of Pharmaceutical Product)

3 Batch Formula

4 Product Secification

! Methods of "nal#sis

$ Samles of La%els & Carton

' Samles of the Product (2 unit ac)

"nal#tical *eort

+ Sta%ilit# ,ata


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+. MANUFACTURIN, LICENSE


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-. CPP 'CERTIFICATE F ANAL/SIS(


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CPP 'CERTIFICATE F ANAL/SIS( : ATTACHED.


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0. 1ATCH FRMULA


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POL-.B (Pol#m#/in B Sulhate 0nection ! 0)

Comosition 5ach 6ial contains

Pol#m#/in B Sulhate BP 788888888888888888888888888 !

9ater for 0nections 0P 788888888888888888888888888888888 :8s8

,escrition of dosage form 9hite l#ohili;ed cae filled in ! ml am%er colour glass 6ial< la%eledC tra# =ith co6er< such one tra# along =ith acing insert is aced

in a carton8

?#e of container and closure

Batch Si;e ' >ials

S!

N%

Name %2

Ing!edient

Se*i2i*

ati%n

St!engt$

e! 3ial

4ty

Re5ui!ed

3e!age&

added

A*tual 4ty

U&ed

Fun*ti%n

18 Pol#m#/in B

Sulhate

BP ! . "nti%iotic

28 9F0 0P :8 s8 . >ehicle

38

@ :8s . Auantit# Sufficient


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6. PRDUCT SPECIFICATIN


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Se*i2i*ati%n %2 Fini&$ P!%du*t :

P!%du*t : PL/71 'P%lymy8in 1 Sul$ate In9e*ti%n ;;;;; IU(

TEST STANDARD LIMIT

,iscrition

9hite l#ohili;edcae filled in ! ml am%er colourglass 6ial< la%elled< stoered and sealed =ith %luecolour fli off seal< such one 6ial aced in P>C tra#

=ith co6er< such one tra# along =ith acing insert isaced in a carton8

0dentification"s er secification

!8 to '8

"6erage filled =eight "s er secification

9ater M? !8D =E=

Particulate Matter Should Coml#

P#rogens "s er secification

Sterilit# Should coml#

"ssa# 4!8 to !!8 nits


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. METHD F ANAL/SIS


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Met$%d 2 Analy&i& %2 Fini&$ P!%du*t :

De&*!iti%n:9hite l#ohili;ed cae filled in a !ml am%er colour glass 6ial la%eled< stoered and sealed =ithblue *%l%u! 2li %22 &eal" &u*$ %ne 3ial a*


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mem%rane filters =ith a ore si;e of 84!Km & 4'mm8

2. Filter the solution under 6acuum ressure or reduced ressure8

3. 9ash the mem%rane =ith three successi6e :uantities of 1 ml 81D sterile etone =ater8

4. "seticall# remo6e the mem%rane from the filter< cut it in to e:ual hal6es8

!. 0mmerse one half the mem%rane in sterile 1 ml Fluid ?hiogl#coiiate Medium tu%e & another in sterile 1 ml So#a%ean Casein ,igest Medium8

N%te. Positi6e control do not erformed in sterilit# testing area8

$. 0ncu%ate So#a%ean Casein ,igest Medium at 2C to 22C and Fluid ?hiogl#coiiate Medium tu%es at 3 C to 3!C for 14 da#s

'. O%ser6ed the tu%es for tur%idit# Egro=th after 24 hours8 ote the o%ser6ation8 o gro=thEtur%idit# should %e o%ser6ed in samle and negati6e control media tu%es8

b&e!3ati%n and inte!!etati%n:1. 0f no e6idence of micro%ial gro=th is found< the reation %eing e/amined asses the test ofsterilit#8

2. 0f e6idence of micro%ial gro=th is found< reser6e the container sho=ing this and unless it isdemonstrated %# an# other means that their resence is due to causes unrelated to rearation%eing e/amined and hence the tests for sterilit# is in6alid8 Performed a retest using same :uantit# Enum%er of samle as in the original test8

3. 0f no e6idence of micro%ial gro=th is found in found in retest samle< the reation %einge/amined asses the test of sterilit#8

4. 0f no e6idence of micro%ial gro=th is found in retest samle< isolate &identif# the organism8 0fthe# are not readil# distinguisha%le from those in original samle< the reation %eing e/aminedfails the test of sterilit#8

!. 0f the# are not readil# distinguisha%le from those in original contaminant< erform a secondresults t=ice num%erE :uantit# of samles8

$. 0f no e6idence of micro%ial gro=th is found in second retest samle< %eing e/amined asses

the test of sterilit#& if e6idence of micro%ial gro=th is found in second retest samle e/aminedfails the test of sterilit#8

Py!%gen :0f intended for use in the manufacture of arenteral dosage form =ithout a further aroriate rocedurefor the remo6al of #rogens< it comlies =ith the test for #rogens inect< er ilogram of the ra%%itNsmass< 1ml of a solution in =ater for inections * containing 18!mg of the su%stance to %e e/amined er

millilitre8


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ASSA/:'1/ HPLC( : 'Limit: 4! units to !! units (

Re5ui!ement:

Aa!atu&:" suita%le PLC caa%le of erforming isocratic< >.>0S detector< samle inector< controller and

integrator or e:ui6alent soft=are8 ?he s#stem is e:uied =ith C.1< 48$2! mm ! K column(S#mmetr# O,S is suita%le)8

Reagent: "nh#drous sodium sulhate< "cetonitrile (PLC grade) and 9ater (Milli.A)8

1u22e! !ea!ati%n : ,issol6e 484$gm of anh#drous Sodium sulhate in +ml =ater and adust to 283 =ith dilute hoshoric acid and dilute to 1ml =ith =ater8

M%bile P$a&e:Mi/ '! 6olume of Buffer and 2! 6olume of "cetonitrile mae adustment if necessar#8 Filter through

84!Km or finer orosit# mem%rane filter8

Diluent :

"cetonitrile 9ater . 2

P!ea!ati%n %2 &tanda!d &%luti%n:9eight accuratel# ! mg Pol#m#/in B sulhate in to !ml 6olumetric flas< and dilute =ith diluent u to!ml8 O%tained concentration of standard of 1 mcgEml8

P!ea!ati%n %2 te&t &%luti%n:?ae =eight of o=der e:8 to ! mg Pol#m#/in B sulhate in to !ml 6olumetric flas< and dilute =ith

diluent u to !ml8O%tained concentration of samle of 1mcgEml 8

HPLC C%nditi%n:0nstrument PLC e:uied =ith >.,etector and suita%le soft=are

Column C.1< 48$2! mm ! K column (S#mmetr# O,S is suita%le)8

9a6e length 21! nm

Flo= rate 18 mlEminute

0nection 6olume 2 Kl

P!%*edu!e:0nect diluent as %lan8 0nect searatel# standard and test rearation< run thechromatograh< record the chromatogram< measure the ma/imum resonse for standard and test

Calculate the content of Pol#m#/in B sulhate as follo=

Cal*ulati%n:"rea of ?est / Conc8 of Std (mcg)............................................... . / Potenc# of Std on as is %asis / "6g8 =eight"rea of Std8 / Conc8 of ?est (mcg)


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B. SAMPLES F LA1ELS CARTNS


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=. SAMPLES >ITH CA


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SAMARTH LIFE SCIENCES PVT. LTD.NANGAL UPERLA, SWARGHAT ROAD,

NALAGARH, DIST. SOLAN, H.P. 174101

QUALITY CONTROL DEPARTMENT

(Under drugs and cosmetic act, 1940 and the Rules there under)

CERTIFICATE F ANAL/SISNAME F THE PRDUCT : P%ly 1 In9e*ti%n,ENERIC NAME : P%lymy8in 1 Sul$ate In9e*ti%n1ATCH N. : -PL1+-MF,. DATE : May -;+0E)P. DATE : A!il -;+B1ATCH SIE : ++-= N%&.DATE F ANAL/SIS : -+@;@-;+0

TESTS SPECIFICATIN RESULTS

,escrition 9hite l#ohili;edcae filled in ! mlam%er colour glass 6ial< la%elledC tra# =ith co6er< such one tra#along =ith acing insert is aced ina carton8

9hite l#ohili;edcae filled in !ml am%er colour glass 6ialC tra# =ith co6er< such one tra# along =ith acing

insert is aced in a carton8

28 !8 to '8

38 9ater M? !8D =E=

48 Particulate Matter Should %e free from articulate matter8

!8 Sterilit# Should %e sterile8

$8 "ssa# 4!8 to !! nits

Re&ult&:

?he results are sho=n in the ta%le for *eal time studies and "ccelerated studies8

C%n*lu&i%n&:

?he resent sta%ilit# testing results sho= that PL/71 'P%lymy8in 1 Sul$ate In9e*ti%n ;;;;; IU(

meets all the re:uirements of the rescri%ed secifications8

Li2e and St%!age Re*%mmendati%n:

"ccording to the resent results of Sta%ilit# testing of PL/71 'P%lymy8in 1 Sul$ate In9e*ti%n ;;;;;

IU(< shelf life of 24 months can %e roosed8


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REAL TIME STA1ILIT/

STUD/ DATA F THREE 1ATCHES


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ACCELERATED STA1ILIT/

STUD/ DATA F THREE 1ATCHES

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