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PROCESS VALIDATION OF LOPINAVIR + RITONAVIR
(100 + 25 mg) ANTIRETROVIRAL COMBINATION
TABLET
1
INDUSTRIAL GUIDE
Mr. NAGESH PATIL
Sr.m!g"r #A $"%&.
Em'r" %rm'"&*',
H*!-"$*/ P!".
DEPARTMENT OF QUALITY ASSURANCE
TECHNIQUES
SINHGAD COLLEGE OF PHARMACY
VADGAON (BK), PUNE-041
PRESENTED B
,& V. !$r3r
M.Prm (IV&SEMESTER)
ACADEMIC GUIDE
Mr,. M.A.NAGRAS
A,,*,&!& Pr4",,4r
SCOP
VADGAON (B)/ PUNE6071
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INSTRUMENTS AND E#UIPMENTS9E#UIPMENTS M3"
R& !" /"&+'&*#" (6:0 L) A+$.#" &"8
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H4& M"& E?&r$"r 9
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A$8!&g", 4 H4& M"& E?&r,*4! 9
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16
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Drug Pr4*":
Drg L4%*!8*r 9
S*"$*"!
C&*!/#"3 A+*"!*"#%"&'
C'&ss HIV P"#*!&s! I+.*#"s
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Drg R*&4!8*r 9
S*"$*"!
C&*!/#"3 A+*"!*"#%"&'IUPAC N&! HIV P"#*!&s! I+.*#"s
M#'5 *5 ;605>44
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E$"!*#+ M#s*'3 !$&'
18
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DESCRIPTION OF MANUFACTURING PROCESS AND
PROCESS CONTROLS (F4r L4%*!8*r + R*&4!8*r T"& (100 + 25 mg) USP)
19
P $*
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2020
R m&"r*, Pr4'",,
Ds!+s+/ # "&2 &*!"&'
L#+&%", "*#+&%" $##%#+!, $#''#&' s'$#+!#!
S*+/
S#"*#+ #+#'&"&*! G"&+'&*#+
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Pr4'",, 4 $*grm
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M!'&r*!gFormula :
Ingredients Use
A) Granulation
Drug Lopinavir (API) Antiretroviral
Drug itonavir (API) Antiretroviral
!opovi"one #in"er
!olloi"al $ili%on "io&i"e Lu'ri%ant
or'itan onolaurate ur*a%tant
o"iu+ $tear,l *u+arate Lu'ri%ant#) !oating o* -a'let
.pa"ar, ,ello/ !oating agent
Purie" /ater olvent *or %oating
21
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Product Composition : lot !4. 1
22
Sr.!4. Nm" 4 m&"r* #!&*&: %"r &"&
*! mg.
#!&*&: %"r &'
*! 3g.
1 L#+&%" IP 10050 ;5;>0
6 R*#+AVIR IP 6:50 15=>>
; C#%#+! s + 447599: 775706
7 C#''#&' s'$#+! #! IP 95990 05:07
5 S#"*#+ #+#'&"&*! 765:00 654;:
@ C#''#&' s'$#+! #! 451;: 05701
S# s*!"3' &"&*! 95000 05476
Total core tablet 618.0 44.46
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23
Pro"u%t %o+po$ition $a+e *or lot no 6,7
!r.no. "ame o#
material
$uantit% per
tablet in mg.
$uantit% per
batc& in 'g.
') !oating o*ta'let
8 .pa"r, ,ello/ 15450 0799 & 2 1558
9 Purie" /aterIp
A 440 & 2 880
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Pr4'",,*!g 4 B&' L4& 9
S*! 15 Ds!+s+/ - As !" '' # "&2 &*!"&'5E!+*s +!!! LAF, !/.* B&'&+$!, $#+*&+!"s
S*! 15 S*+/ V"&*#"3 s*!" *."#/. 405 $.!$8 .3s$&' +*!/"*3 # s!%!
!#"! &*!" s!
S*! 75G"&+'&*#+ L#& s*! +/"!!+* + RMG #" 10 +5 2*.
!''!" &* &s* s!! &+ $.#!" # 5$.!$8 +/ *! s!! #!''!"
S*! 45 H#* M!'* E*"s#+ (HME) F!! "&*! 45: 8/ *#66 8/."5 s$"!2 "
100 9;: " *#"! 70 *# 90
S*! :5 SJ! "!$*#+ - F* 750 s$"!!+ *# $& '' '' *.! !*"&*!s &*
&s* s!! 8+! #"2&"5 s* *.! ''! /"&+'!s *."#/. 70 s!%! *#%"&*#"3 s*!"
24
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25
S*! 95 L"$&*#+ S* $#''#&' s'$#+! #! IP s# s*!&"3'
&"&*! *."#/. 40 s!%!5 L#& /"&+'!s + 1:0 L $&/! +8!" &**&$.
* *# ''&" *3! $#+*& '!+!" #" : +5 '!+!" s!! &* 16 "+ &+&' #!
S*! ;5 C#"!ss#+ s+/'! "#*&"3 7; s*&*#+ L!/&$3 9100
!" +$.!s < 19 > #%&' s.&!
'#2!" +$.!s < 19 > 69
D!s< < 19 > #%&' s.&!
S*! >5 Ds!+s+/ # C#&*+/ M&*!"&'
S*! 105 P"!&"&*#+ # F' C#&*+/ "! 2&*!" #&"3 3!''#2 '&"/!
' #"&*#+ &%#!5 S*" #" 4: +5 '*!" *."#/. s'+ $'#*.5 Us!$#&*+/ s#'*#+ 2*.+ 64 .#"s5
S*! 115 C#&*+/ 3 N!# $#*&5 C#&*+/ # *&'!* *# ! #+! *# & 2!/.* /&+
# * 65:
S*! 165 P&$8&/+/ As !" &"8!* "!"!!+*5
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A,,",,m"!& 4 'r*&*' %r4'",, %rm"&"r, 9
26
!r.no Process step Process parameter rationale C&ec's critcal steps
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27
. setting
1 a/ +aterial A a/ +aterial u$e" arepro%ure" *ro+ approve"ven"or$
A o
2 Di$pen$ing o*ra/ +aterial
Di$pen$e ra/ +aterial a$per 'ill o* ra/ +aterial
Pro%e$$ "oe$ not avevaria'le ee%t on pro"u%tualit, /en "ene"operating pro%e"ure$ are*ollo/e"
#alan%e%ali'ration 'e*ore"i$pen$ingoperation to 'e"one
o
3 i*ting i*t lopinavir ritonavir%opovi"one %olloi"al$ili%one "io&i"e troug
40 $ieve
Pro%e$$ involve$ 'reaingo* agglo+erate$ i* an,
P,$i%al integrit,o* $ieve 'e*ore :a*ter u$e
o
4 Granulation Dr, +i&ing in rapi" +i&ergranulator 250 L /it tea""ition o* $or'iton+onolaurate
i&ing ti+e to en$ureproper +i&ing
i&ing ti+e $pee"o* i+peller :%opper
;e$
5 ee" rate
;e$
7 i*ting o* e&tragranular
ingre"ient$
$i*t te %olloi"al $ili%one"io&i"e : $o"iu+ laur,l
*u+arate troug 40$ieve
Pro%e$$ involve$ 'reaingo* $o*t agglo+erate$ i* an,
P,$i%al integrit,o* $ieve 'e*ore :
a*ter u$e :>ee" rate
o
!r.no. Process Process parameter setting (ationale C&ec's Critical steps
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28
!r.no.step
8 Lu'ri%ation Lu'ri%ation o* granule$ /it $i*te"%olloi"al $ili%on "io&i"e : $o"iu+laur,l $ul*ate *or 5 +in ', eepingte %onta 'len"er $pee" at 12 rp+
i&ing ti+e toen$ure proper+i&ing properlu'ri%ationreuire" toa%ieve opti+u+
%o+pre$$ionpropertie$ *or nal'len"
te$ting a$ per$a+pling plan
;e$
9 !o+pre$$ion
!o+pre$$ te ta'let$ at opti+u+$pee" u$ing %o+pre$$ion +a%inelega%, 6100 $ingle rotar, 37 $tation
-o $et te%o+pre$$ionpara+eter$ : toa%ieve reuire"%o+pre$$e"
/eigt
-e$ting a$ per$a+pling plan
,e$
10 !oating !oating o* ta'let$ to 'e "one to a/eigt gain o* a'out 25 @
-o $et te %oatingpara+eter$ : toa%ieve reuire"%oating /eigtgain
-e$ting a$ per$a+pling plan
,e$
12 Pa%aging A$ per 'at% pa%aging re%or"$ -o evaluatepa%agingpara+eter$
-e$ting a$ per$a+pling plan
,e$
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!ampling %!:
29
Pr4'",, ,&g" Sm%" *$ Sm%*!g $"&*, > !&*&: T",&,
L"$&*#+ 1 LG 01 *# 1 LG70
70 +* #s! s&'!s, 10 s&'!s+ *"'$&*! s.&'' ! $#''!$*! #*# 2.$. #+! s!* # 10 s&'!ss.&'' ! &+&'3J!C#''!$* & ##'! s&'! # 600/
B'!+ +#"*3T!s*+/ #+ ##'!
s&'!Ass&3, L#ss #+ "3+/
C#"!ss#+ I+*&', '! !+&* #* s!! .&"+!ss
100 *&'!*s &"! *# ! s&'! &*+*&', '! !+ # *&'!*$#"!ss! &* #* s!! .&"+!ss
P.3s$&' &"&!*!"sss#'*#+
$#"!ss#+&$.+! s!!
P##'! s&'! &*#* s!! .&"+!ss
100 *&'!*s &"! *# ! s&'! &s#''! s&'! &* #* s!! .&"+!ss
Ass&3, ss#'*#+
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30
Pr4'",, ,&g" Sm%" *$ Sm%*!g $"&*, >!&*&:
T",&,
C#&*+/ P##'! s&'! C#''!$* 1 #''!s&'! &*!"+'#&+/ # $#&*!*&'!*s s&'+/&+**3 100 *&'!*s
D!s$"*#+ ,&ss&3 ,Dss#'*#+
P&$8&/+/ O+! ##'! s&'!$#''!$*! "+/ *.! !+*"!&*$. &$8+/ 5 S&'+/&+**3 &s !" +s.!
"#$* s!$$&*#+
S&'+/ &+**3 &s+s.! "#$*s!$$&*#+
P&$8&/+/&"&!*!"s "#B&*$.&+&$*"+/
"!$#"s
C4!&*.
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)cceptance criteria :
31
S&g" T",& I! Pr4'",, C"'3,
L"$&*#+ D!s$"*#+ .*! *# # 2.*! /"&+'&" #2!"
B'!+ +#"*3 R!'&*%! s*&+&" !%&*#+ +#* #"! *.&+ :
Ass&3 N#* '!ss *.&+ >0 +#* #"! *.&+ 110 #'&!'! +* # "*#+&%" '#+&%"
C#"!ss#+ D!s$"*#+ .*! *# # 2.*! +$#&*! #%&' *&'!*s !#ss!2*. EM #+ #+! s! 6: #*.!" s!
Dss#'*#+ N#* '!ss *.&+ ;0 # '&!'! +* # "*#+&%" IP
s ss#'%! + 160 +5N#* '!ss *.&+ ;0 # '&!'! +* # '#+&%" IPs ss#'%! + 160 +5
C#&*! *&'!*s Ass&3 N#*'!ss *.&+ >0 +#* #"! *.&+ 110 # '&!'!
+* # "*#+&%" '#+&%" IP
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!c&ematic sampling plan o# Conta"!$"r:
>ig B a+pling !%$!
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Sm%*!g 4'&*4!,9
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T4% 1 "& r4!& ; "& r4!& 5 r*g&r4!&
r*g&'3
1,11,61 7,17,67 :,1:,6: ;,1;,6;
B#**# 6 '!* "#+* 4 '!* &$8 9 "/.*"#+*
= "/.*&$8
6,16,66 4,14,64 9,19,69 =,1=,6=
C!+*"! - - - - > '! 10 #**#
>,1>,6> 10,60,70
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Pr4'"$r":
1) .'tain 3 unit "o$e $a+ple$ *ro+ $#+*& 'len"er (%age'uner) *ro+ ea% po$ition a$ $o/n in a'ove gure an"a$ "e$%ri'e" in ta'le given 'elo/
2) C$e appropriate $a+ple tie*E /it te appropriate "ie to
o'tain $a+ple$ /it net /eigt o* 1 & to 3 & ti+e$ tetarget /eigt
3) C$e la'ele" : /eige" $a+ple %ontainer$ $u'+it te$a+ple to ualit, %ontrol "epart+ent *or te$ting along /itappropriate te%ni%al in*or+ation $eet
34
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E?%"r*m"!&9
35
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36
Pr4'",,*!g ,&g" Cr*&*' %r4'",, %rm"&"r, R"'4mm"!$"$ *m*&(,)r!g"(,)
C4&*!g O*'!* *!!"&*"! 69C *# 7=C
P!"s*&'*$ s!! 10 RPM *# 60 RPM
T#*&' A" P"!ss"! : 8/$6 *# 1: 8/$6
*"$ D"/ C#&*+/ >750 *# 10650
B&""!" C#&*+/ >750 *# 10650
E+*!"$ C#&*+/ >750 *# 10650
!ummar% o# Pr4'",,
Parameters:
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R",&, > $*,',,*4!9
37
R",&, 4 "!$ !*4rm*&:9
Sm%" I$ B"!$*!g '4!&"!& 4
B"!$*!g '4!&"!& 4
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38
'4!&"!& 4R*&4!8*r
'4!&"!& 4R*&4!8*r
B&' !4. 1 B&' !4. 2 B&' !4. ; B&' !4. 1 B&' !4. 2 B&' !4. ;
1 .5 .0 .7 102.1 100.2 100.0
2 .; .7 .7 102. 100.@ 100.1
; .; .; .0 100. 100.; .
7 .2 .@ .1 100. . 100.@
5 .2 . .0 100. 100. 100.@
@ .@ .5 .@ 10;.1 100. 100.1
.5 .0 .; 100.0 101.1 100.0
. .@ .; 100.; 100. .
.; .0 .7 102. 100.; 100.2
10 .7 .7 .7 10;.1 100.7 100.1
A8"rg" .; .; .; 102. 100.5 .
M*!. .5 .@ .0 102.1 . .@
M?. . .0 .@ 10;.; 101.1 100.2
RSD. 0.7 0.7 0.2 0.; 0.7 0.2
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A!:&*' $& 4 %44"$ ,m%" & &" ,&g" 4
r*'&*4!9
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Sr.!4.
T",& A''"%&!'" 'r*&"r* T",& R",&,
B&*$. +#5 1 B&*$. +#5 6 B&*$. +#5 7
1 D!s$"*#+ .*! *# # 2.*!#2!"
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.*! *# #2.*! #2!"
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6 B'8 !+s*3 R!$#" *.! "!s'*s 05:; /' 05:9 /' 05:; /'
7 T&! !+s*3 R!$#" *.! "!s'*s 05;4 /' 05;6 /' 05;4 /'
4 S!%! &+&'3ss F#" +#"&*#+ #+'3 40 < >57 / 40 < 105= 40 < 1051
: Ass&3 (R*#+&%") NLT >050 NMT11050
>=5: >=54 >>5>
9 Ass&3 (R*#+&%") NLT >050 NMT11050
10751 10057 10054
; L#ss #+ "3+/ F#" +#"&*#+ #+'3 05; 15: 157
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A!:&*' $& 4 &"&, '4m%r",,"$ & 4%&*mm
,%""$ 9
40
T",& A''"%&!'" 'r*&"r* T",& R",&,
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I+%&' *&'!*2!/.* "&+/!
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H&"+!ss 1750 8 -: 8L* = 8 *# 1= 8
1754 1759 175;
T.$8+!ss :5;: *# 0570 L* :54: *# 950:
:5=4 :5=: :5=4
F"&'*3 NMT 150 22 056 22 051 22 056 22
Ds+*!/"&*#+
*!
NMT 90 +5 76 +5 76 +5 76 +5
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D*,,4&*4! 4 *!*&*/ m*$$"/ "!$ ,m%"9
A''"%&!'" 'r*&"r*9
N#* '!ss *.&+ ;0 # '&!'! +* # "*#+&%" IP s ss#'%! + 160 +5
N#* '!ss *.&+ ;0 # '&!'! +* # "*#+&%" IP s ss#'%! + 160 +5
41
T"& !4. D*,,4&*4!
&
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42
r",&,
R*#+&%" IB&*$. 1
s#''*3
B&*$. 6 s#''*3
B&*$. 7 s#''*3
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s#''*3
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B&*$. 7
s#''*3
I+*&' M'! E+ I+*&' M'! E+
1 >= >; >= 100 >= 100
6 >= >= >= 100 100 >>
7 >= >= >= 100 101 >>
4 >= >= >= 100 100 100
: >= >= >; 100 >> >=
9 >= >> >= 100 101 100
A%/5 >= >= >= 100 100 >>
M+5 >= >; >; 100 >= >=
M&5 >= >> >= 100 101 100
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D*,,4&*4! 4! %44"$ ,m%"9
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T"& !4. D*,,4&*4!
r",&,
R*#+&%" I
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s#''*3
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s#''*3
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B&*$. 1 s#''*3
B&*$. 6
s#''*3
B&*$. 7
s#''*3
1 >= >; 100 100 >> 106
6 >= >; 100 100 >> 101
7 >= >= >> 100 100 101
4 >; >; >> 100 >> 100
: >= >; >= 101 >> 100
9 >= >> 100 100 101 101
A%/5 >= >; >> 100 >> 101
M+5 >; >; >= 100 >> 100
M&5 >= >> 100 101 101 106
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A,,: 4 %44"$ ,m%"9
44
T",& A''"%&!'"'r*&"r*
B&' 1 B&' 2 B&' ;
Ass&3 NLT >050 NMT 11050 #
'&!'! +* #"*#+&%" IP
1015; 10151 >>5:
NLT >050
NMT 11050 #'&!'! +* #'#+&%" IP
>=59 >=51 10159
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R",&, 4 $*,,4&*4!9 4 ,%""$ (20 r%m)
45
T"&
!4.
R"","$
(R*&4!8*r)
R"","$
(L4%*!8*r)
B&*$. 1 B&*$. 6 B&*$. 7 B&*$. 1 B&*$. 6 B&*$. 7
1 >= >= >9 >= >> >>
6 100 >> >9 100 >> >>
7 100 >= >9 100 >> >>
4 100 >= >9 >> >> >=
: >> >> >9 >= 100 >>
9 >> >; >9 >> >; >>
A%/5 >> >= >9 >> >> >>
M+5 >= >; >9 >= >; >=
M&5 100 >> >9 100 100 >>
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R",&, 4 $*,,4&*4!9 *g ,%""$ (70 r%m)
46
T"&
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R"","$
(R*&4!8*r)
R"","$
(L4%*!8*r)
B&*$. 1 B&*$. 6 B&*$. 7 B&*$. 1 B&*$. 6 B&*$. 7
1 >> >> >9 >= 100 >>
6 >> >= >; >> >= 100
7 100 >= >9 >> >> >>
4 100 >= >= 106 100 101
: >> >> >; >> >> 100
9 100 >= >9 100 >= >>
A%/5 >> >= >; >> >> >>
M+5 >> >= >9 >= >= >>
M&5 100 >> >= 106 100 101
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C4&*!g %rm"&"r,9
47
%rm"&"r, R!g" S 4& 1 S 4& 2
I+'!* &" *!5 7: *# ;00$ :6 *# :70$ :6 *# :7 0$
P&+ s!! 1 *# ; " : " : "
A*#J!" &""!ss"!
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N!" # /+s 6 N#s 6 N#s 6 N#s
Ds*&+$! # *.! /+s"# *&'!* !
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C#&*+/ s#'*#+s"&3 "&*!
10 *# =0 '+/+ 66 '+/+ 66 '+/+
2!/.* /&+ 65: 659 659
G+ *# /+ s*&+$! 10 *# 6: $ 1= $ 1= $
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A!:&*' $& 4 %44"$ ,m%" & &" ,&g" 4
'4&*!g 9
48
T",& A''"%&!'" 'r*&"r* T",& r",&,
B&*$. 1 B&*$. 1 B&*$. 1
D!s$"*#+ P&'! 3!''#2 ' $#&*! #%&'
*&'!* !#ss! 2*. EIM #+#+! s! 69 #+ #*.!" s!
Ass&3 R*#+&%" I NLT >050 NMT 11050 #'&!'! +* # R*#+&%" I
1015= 10157 >>57
Ass&3 L#+&%" I NLT >050 NMT 11050 #'&!'! +* # L#+&%" I
>=59 >=56 10154
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D*,,4&*4! 4! %44"$ ,m%" 4 '4&"$ &"&,9
49
A''"%&!'" 'r*&"r*9
N#* '!ss *.&+ ;0 # '&!'! +* # "*#+&%" IP s ss#'%! + 160
+5
N#* '!ss *.&+ ;0 # '&!'! +* # '#+&%" IP s ss#'%! + 160 +5
T"& !4. D*,,4&*4!r",&,
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50
r",&,
R*#+&%" IB&*$. 1
B&*$. 6 B&*$. 7 L#+&%" IB&*$. 1
B&*$. 6 B&*$. 7
I+*&' M'! E+ I+*&' M'! E+
1 >= >; >= 100 >= 100
6 >= >= >= 100 100 >>
7 >= >= >= 100 101 >>
4 >= >= >= 100 100 100
: >= >= >; 100 >> >=
9 >= >> >= 100 101 100
A%/5 >= >> >9 100 >> >>
M+5 >; >= >9 >> >> >>
M&5 100 >> >; 106 100 100
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P'3g*!g 4,"r8&*4!9
51
P'3g*!gB&'. N4.
P'3 ,&:" P'3g*!g m&"r* ,"$4r %'3*!g
1 1 90 T&'!*s HDPE C#+*&+!" ,$'#s"! 7= , s'$& /!'
6 1 90 T&'!*s HDPE C#+*&+!" ,$'#s"! 7= , s'$& /!'
7 1 90 T&'!*s HDPE C#+*&+!" ,$'#s"! 7= , s'$& /!'
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P'3g*!g 4,"r8&*4!9
52
C"'3, A''"%&!'"'r*&"r*
O,"r8&*4!
B&*$. 1 B&*$. 6 B&*$. 7
S!! # $&+/
&$.+!
L* 70 *# 40
#**'!s+
:9 #**'!s+ 90
#**'!s+
96
#**'!s+P!"$!+*&/! +$*#+ #"
+$*#+ $& s!&'!"L* ;0 *# >:
>0 >0 >9
T#"! #" $&+/&$.+!
L* 1;569+$.
1> +$. 1> +$. 1> +$.
N!" # *&'!*s + *.!''! HDPE $#+*&+!"
90 *&'!*s 90 *&'!*s 90 *&'!*s 90 *&'!*s
L!&8 *!s* S.#' &ss*.! *!s*
S&*s&$*#"3 S&*s&$*#"3 S&*s&$*#"3
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A!:&*' $& 4 *!*,"$ %r4$'&9
53
T",& S%"'**'&*4! Pr4$'&
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54
1 D!s$"*#+ P&'! 3!''#2 ' $#&*! #%&' *&'!* !#ss!2*. EIM #+ #+! s! 69 #+ #*.!" s!
C#'!s
6 I!+*$&*#+ 3HPLC
T.! "!*!+*#+ *! !&8 ! *# '#+&%" "*#+&%" + &ss&3 "!&"&*#+ $#'!s *# *.&*
#*&+! "# s*&+&" "!&"&*#+
C#'!s
7 &*!" !*!+* NMT 950 750
4 Ass&3 NLT >050 NMT 11050 # '&!'!+* # R*#+&%" I
1015=
NLT >050 NMT 11050 # '&!'!+* # L#+&%" I
>=59
: R!'&*! ss*&+$!(L#+&%" )
A+3 +s!$!"*3
NMT 150 L!ss *.&+ 150
T#*&' "*3 NMT 650 L!ss *.&+ 650
9 R!'&*! ss*&+$!(R*#+&%" )
A+3 +s!$!"*3
NMT 65: L!ss *.&+ 65:
T#*&' "*3 NMT 750 L!ss *.&+ :50
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R",&, 4 Cr*&*' %r4'",, %rm"&"r, 4 Drg '4&*!g 9
55
Prm"&"r, S%"'**'&*4!,O,"r8&*4!
B&' 1 B&' 2 B&' ;E!+* +&! N!# $#*& N!# $#*& N!# $#*& N!# $#*&
E!+* ID N#5CHMCTAB
600>777
CHMCTAB
600>777
CHMCTAB
600>777
I+'!* &" *!!"&*"! 47C(7:C *# ;0C) :7C :1C :7C
O*'!* &" *!!"&*"! T# ! "!$#"!(C) 47C 44C 47C
B! *!!"&*"! 4>C (44C *# :4C) :0C :0C :1C
A*#J&*#+ &" "!ss"! 150 *# 750 8/$6(15= *# 750) 650 650 650
N!" # G+s 6 N#s5 6 6 6
Ds*&+$! # *.! /+s "#*&'!* !
14 *# 6: $ 60 60 60&
C#&*+/ s#'*#+ s"&3
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2!/.* /&+ 65: ( 650 *# 750) 659 659 659G+ *# G+ s*&+$! 10 *# 6: $ 1= $ 1=$ 1=$
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F*! &' :*"$ !$ R"'4!'**&*4! 9
56
Prm"&"r, S%"'**'&*4!,
O,"r8&*4!
1 2 ;
Drg C4&*!g
T.!#"!*$&' Y!' T# ! !s*&'s.! 4:590= 8/ 4:590= 8/ 4:590= 8/
A$*&' Y!' T# ! !s*&'s.! 4:5100 8/ 4:560; 8/ 4:5600 8/
R!$#+$'&*#+ T# ! !s*&'s.! >=5== >>516 >>510
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R",&, 4 I!6%r4'",, !:,*, 4 Drg '4&*!g 9
57
Prm"&"r, A''"%&!'" Cr*&"r*R",&,
1 2 ;
D!s$"*#+P&'! 3!''#2, ' $#&*! , #%&' *&'!* !#ss! 2*.
EIM #+ #+! s! 69 #+ #*.!" s!C#'!s
C#'
!sC#'!s
I!+*$&*#+
(B3 HPLC)
T.! "!*!+*#+ *! # *.! &@#" !&8 + *.!
$."#&*#/"& # *.! s&'! "!&"&*#+ $#""!s#+s
*# *.&* + *.! $."#&*#/"& # *.! s*&+&"
"!&"&*#+, &s #*&+! + *.! &ss&35
C#'!sC#'
!sC#'!s
&*!" $#+*!+*
(3 KF)NMT 9 22 7 22
65;
22659 22
C#+*!+* +#"*3(1)M!&+ # &'' "!s'*s s >0 *# 110 # *&"/!* &ss&35
(6)RSD # &'' +%&' "!s'*s< NMT :50
M+ < >;51
M&< >>59
A%!"&/! < >=50
RSD < 05=
M+
;50
M&
>5>
A%!"&/!
< >=50
RSD
M+< >:5>
M& < >;50
A%!"&/! < >95:
RSD < 057
Ass&3
(B3 HPLC)
N#* '!ss *.&+ >050 N#* #"! *.&+ 11050 #
'&!'! +* # R*#+&%" IP1015= 10157 >>57
LOD 3 #s*"! &+&'3J!" &*
10:C + &*# #!F#" +#"&*#+ #+'3 05; 15: 157
Pr&*'" ,*" $*,&r*&*4!
R!*&+ #+ 70 NMT : 051 051 051
B!*2!!+ 64 &+ 70 NLT=0 >=50 >=5: >;5=P&ss *."#/. 64 NMT : 159 151 159
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R",&, 4 F*!*,"$ %r4$'& !:,*, 9
58
P&"&!*!"s S!$$&*#+sR!s'*s
1 6 7
D!s$"*#+
P&'! 3!''#2, ' $#&*! , #%&'
*&'!* !#ss! 2*. EIM #+
#+! s! 69 #+ #*.!" s!
C#'!s C#'!s C#'!s
I!+*$&*#+
(B3 HPLC)
T.! "!*!+*#+ *! &+ *.! !&8
! *# L#+&%" "*#+&%" +
&ss&3 "!&"&*#+ $#""!s#+ *#
*.&* #*&+! "# *.! s*&+&"
"!&"&*#+ &s "!$*! + *.!
*!s* #" &ss&35
C#'!s C#'!s C#'!s
&*!" $#+*!+* NMT 9 22 750 22 750 22 750 22
Dss#'*#+
S*&/! A < NLT ;: (D) # *.!
'&!'! +* # L#+&%" IP
s ss#'%! + 160 +5
S*&/! B < NLT ;: (D) # *.!
'&!'! +* # R*#+&%" IP
s ss#'%! + 160 +5
S*&/! A (+)< 050
S*&/! A (&)50
S*&/! B (&%/5);51
S*&/! A
(+) < 050
S*&/! A (&) 050 *# 110 # *&"/!* &ss&35
6) M!&+ # &'' "!s'*s s >:50
*# 10:50 # *&"/!* &ss&35
7)RSD # &'' +%&' "!s'*s
NMT :50
M+< >;5=;
M&< >=59
A%!"&/!< >=57
RSD< 057
M+< >;56
M&< >=54
A%!"&/!< >;5>
RSD< 054
M+< >75:
M&< >=5;
A%!"&/!< >957
RSD< 15>
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Cr*&*' %r4'",, %rm"&"r, !$ R"'4mm"!$"$ r!g" 9
59
Pr4'",,*!g ,&g" Cr*&*' %r4'",, %rm"&"r,R"'4mm"!$"$
*m*&(,)r!g"(,)
C#&*+/
O*'!* *!!"&*"! 71C *# 44C
P!"s*&'*$ s!! 10RPM *# 60RPM
T#*&' A" P"!ss"!: 8/$6*# 1:
8/$6
D"3+/
T#*&' D"3+/ *! U *# 140 +*!s
E.&s* &" *!!"&*"! (&* *.! !+ #"3+/)
7:C *# 40C
L#ss #+ "3+/ (LOD) NMT 15:22
Y!' D"/ C#&*+/ >750 *# 10650
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60
T.s "!#"* !'&+s *.! !*&'s # &*$. &+**!s, !!+*s &+&'3*$&'
"!s'*s 2*. s*&/! 2s! $#+$'s#+5
T!s* "!s'*s &*& /!+!"&*! "+/ *.! "#$!ss %&'&*#+ s*!s $#'! &s
"#$!ss %&'&*#+ "!#"* 5
A'' *.! !!+*s s! #" *.! &+&$*"+/ # '#+&%" "*#+&%" *&'!*s2!"! %!"! #" $'!&++/ #+ 2*.+ *.! &$$!*&+$! $"*!"&5
T.! "#$!ss %&'&*#+ 2&s !"#"! s+/ &'! !!+*s &s !"
+s*"$*#+s /%!+ + BMR BPR
Smmr: 9
A'' *.! !!+*s s! #" &+&$*"+/ # "#$* 2!"! %!"! #"
$'!&++/ &+ #+ 2*.+ *.! &$$!*&+$! $"*!"&
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B&s! #+ &'' *.! &+&'3*$&' &*& * $&+ ! $#+$'! *.&* *.! "#$* $#'!s 2*. *.!
&$$!*&+$! $"*!"& &s !" *.! "#$!ss %&'&*#+ "#*#$#'
T.s "#$!ss "#$!s *.! #$!+*! !%!+$! *.&* *.! "#$!ss $&+ !!$*%!'3 "!"#$!
& "#$* 2*. *.! $""!+* &"#%! s!$$&*#+ &'*3 s*&+&"s5
61
C4!',*4!9
C#&*+/ # &'' *."!! $#+s!$*%! &*$.!s $&""! #* s+/ N!# $#*& !!+*5
I* $&+ ! $#+$'! "# "!s'*s *.&* $#&*+/ # *.!s! &*$.!s s+/ N!# $#*& !!+* s
s&*s&$*#"35
P"#$!ss %&'&*#+ s*3 #+ $#+s!$*%! *."!! &*$.!s s s$$!ss''3 $#'!*! &+ *.!
&+&$*"+/ $"*$&' "#$!ss &"&!*!"s 2!"! %&'&*! + *.s s*35
T!s* "!s'*s &*& /!+!"&*! "+/ *.! "#$!ss %&'&*#+ s*!s $#'! &s "#$!ss
%&'&*#+ "!#"*
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R""r"!'",9
1) T.! E"#!&+ A/!+$3 #" *.! E%&'&*#+ # M!$+&' P"#$*s5 G&+$!#+ P"#$!ss V&'&*#+, C&+&"3 .&", L#+#+, 70*. S!*!!" 1>>>5
6) D%s#+ # M&+&$*"+/ &+ P"#$* Q&'*35 U5S5 F## &+ D"/
A+s*"&*#+5 G!'+!s #+ G!+!"&' P"+$'!s # P"#$!ss V&'&*#+,
US D!&"*!+* # H!&'*. &+ H&+ S!"%$!s, P'$ H!&'*. S!"%$!,
F## &+ D"/ A+s*"&*#+, 1>=;57) S& F## D"/ A+s*"&*#+5 D"/ S!$*#"5 G!'+!s #" P"#$!ss
V&'&*#+ # P.&"&$!*$&' D#s&/! F#"s, K+/# # S& A"&&,
6010, V#'5 6, > 175
4) H&!" SI5 P.&"&$!*$&' M&s*!" V&'&*#+ P'&+< T.! '*&*! /! *#
FDA, GMP, &+ GLP $#'&+$!, I+#"& H!&'*.C&"!, 60065:) USFDA G&+$! #" I+s*"3 P"#$!ss V&'&*#+< G!+!"&' P"+$'!s &+
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