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3.2 iioai~sznau~loan=jmo::Zu (% WMI) 1riljosnii~q~io1d4'

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- Arsinine 6.6

I - Aspartic acid 5.5

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- Histidine. 0.9. , . . . . . . 1 . . .

. . . .

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. .

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-- Phenylalanine 2.0.

- Proline 12.3 . : . . - Serine 2.7

.- . Threonine ' . 1.6 . . . .

- Tyrosine 0.7 ' . . .

-. - Valine 2.6 .. . .

. . . ' 3.3 & s & d ~ z n ~ & j isdobJd . . . . . .

. .

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. . . . - ' Totat. nitrogen (N) ' > 12% . . . . . . . . . : . . .

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: - ~ r n i n o ( ~ ' ) / ~ o t a l (N) ' ~ 0 . 2 5 . : ' . ; . . . . .

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... . . . . - - - Indole .... . ' . absent . . '. . : .. . .

. . . . . . . . . . . : . . ,

. . - . . . . . .

. . - Proteoses . . . . ' . absent . ' . . . . . . . . . . : : . . . .

. . . .. : 3-4 Powder densityloose/packed: 0.25-p.35: units.. .' . . " . . . -:: . . :' . . . . . . . _ . . . . .

. . . .

. . . .

. . , 3.5.. Powder fineness :<I096 retainedon 160 prn mesh or Nbi 80 uSP sieve . . . . . .

. . . . . d d . . . . . . . . : . . . . 3.6 $ n v m a ~ ~ m : yellowish powder . ' . . . .

. .

. . . . . . 3.7 .. ninnauaik~ : completely. soluble in watei Q 2% w/v) , . .

. . . 3.8. pH (10% aqueous . . solution). . . . . . : . 5.0-7.0 . . ' / ; " . . .. . . . . . . : " . . . . . . . . . . . . . .

... 4. *?.@ @lqdt~.i* 30%6.~~bZ . . q@bq+/bi . . . / . fiuiw@un% . . . . . .

. . , 569m.. . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . i . . .

. . ' . . . ,

3.9 Gui~gGum:v' - Total aerobic microbial count (CFU) < 10.1s - Yeasts and molds (CFU) < 100 1 s - Pathogens absent

4. C ~ I M R ~ U 7 . .

. . 4.1 ~ann~&asuuuunawigan ua:: certificate of analysis n u ( u a ~ h w a n i s ~ r n ~ i ~ 6 o s ~ d ~ ~ n o u ~ i ~ Y 9 1 nmynSiuni~miu$o 3.2 mr 3.3) ~uou"~~"so~i~lruls~nu~'t3'~1ywali;l w ~ o u a a d o u a ~ d s z v i u m 5 ~ ~ 5 \ ~ ~ ~

~auas1n7u1w5arj%u~auo~iwilu~urarf~a5ini

4.2 ~ ~ a u a ~ i n i ~ r 6 ~ ~ ~ ~ a o d i a r j i a a u ~ ~ ~ m = : n ~ ~ n i ~ ~ i ~ % u ~ z u u V ~ ~ n i ~ n " i ~ u ~ < ? u ~ u E 6 a ~ n j i 10

~ban~uu~st~unimrsMdu55~s~r1b~~sif~~~~m (orisinat packins) ~ ~ a r i i n i ~ ~ ~ a ~ n 1 5 1 ~ s i u bslul$ ~~ai Iuf l i5n~aou 15 avld

. . 4.3 ~ % I u ~ % ~ u u u u A ~ ~ I ~ ~ ~ wr certiiate of analysis ( ~ s u y n ~ i u n i s ~ i ~ ~ a 3) th~u'u~~aioh~uioin.

u5*(irZi ~ ~ i r j a s d a u a g ~ s r r i u n s ~ ~ ~ ~ ~ ~ ~ ~ u l d d i s u a w . .

44 uanisn~gauiia~9u~on8~$~a4n5~qa"m~ ~ ~ ~ i a u o s i r n o ~ ~ o t L a G ~ n ~ i ~ 3 ~ ~ i u l n . . 7 516 ~ i n i dil&i~utuniAnam, ~~auanf i ias .&aqs"p I~~~eudi l~ i iudX~~~m .

4.5 ~ r i 4 a J r m o : : ~ ~ ~ L ~ y n n i 5 u ~ a (Batch . . d e Lot ) t~878A~fl'

4.6 - u ~ j n i 5 d ~ 1 e ~ ~ 1 ~ n ~ ~ ~ 1 u b a ~ ~ ~ n " ~ 6 ~ ~ ~ ~ ~ i n i ~ ~ ~ ~ a a ~ i ~ ~ 1 i l " i n i 5 n m ~ a ~ n i 5 ~ ~ ~ i u ~ ~ ~ ~ u . . - ruaurnsw~~nn~s rii~umm~a&ukol;iia~~u~~5m5a~1s"u'L6. . -. .

4.7 ' ~ ~ d ~ ~ ~ 0 ~ ~ ~ ~ ~ ~ ~ ~ u w 8 ~ n ' ~ b 3 1 ' 0 ~ ~ M d ~ 0 ~ ~ ~ l 5 ~ . a ' . j i ~ ~ l d " ~ ) ~ ~ ~ ~ i 2 5 *in~udsuou. . . . .

d -4

4.8 * i ~ u u s s g ~ m ~ ~ i n ~ 5 ~ s i ~ ~ u a ^ h (original packaging) L&& ~aamssyrroau61 L& number . . P U L I c r . ' Y 4

- U~%MWWR? v.. dsam~rwuwam. ?"uwi?n uas/~?oTuhmeqq , ,

4.8 %uimufi? 10 ,I5 ,M v& 25 nn/us=ign"m9? .

.

49. z ~ Q ~ @ u M ~ s ~ I ~ ~ L ~ ~ I u ~ ~ ~ ~ ~ K N o ~ ~ " ~ ~ 6.dirioa' avmsiwilui .. ' . ,

- . ..- . . .

. - . . . .

d - . . . . n t ~ ~ a ...................... . . tl.j.uuitiunsrun15 n$~un7s

. . . . . . ..

. . . .

J d ' . ,. i . . d . . . . . . .

.. .... ...............................* ........ ........... n ~ ' t l ~ : : n5=irjni5 navo - . . . . .

., . . . . .

. : , .

. . a . v s . . . . . . .......................... .... ...,......,... . . . n s s u n ~ s u a ~ ~ ~ 3 f l ~ n v i y n i ~

. . ... , . .

. . . . - . . . . . . .

. . . . . . .

. . . . . .

. . . .

. . . . a ........................... . . . . . . . . .

. . . . . . (trim ni smstil~iid . . . . . . .

3. ~nwtUgrawia 3.1 niswga : Pancreatic digest of lactalbumin

3.2 R Y ~ W ~ J J Z ~ L I % J : free flowing powder, yellow beige to tan

3.3 nisauaiu : Clear to slightly hazy, or gold to amber with no precipitate

3.4 pH (2% aqueous solution) : 6.5-7.5

3.5 aa6dsanoudiG~ : amino acid

3.6 aa6d~mauih.~ 7 - Total nitrogen > 10%

- Amino nitrogen > 4%

- Amino nitrogen~otal nitrogen - - 0.4%

4. bn"1~~clL q 4.1 ~~~uwlni~aakuukfl~m1n"an uns certificate of analysis ( A 5 ~ ~ ? 5 1 8 n l ~ ~ l U ~ ~ 3) ~u~u(I&M%~

? f i ru i~ i rn iG~~~ i r lm n l u n a % a ~ ~ ~ ~ ~ a n ' u o 1 ~ i ' ~ ~ ~ ' ~ 1 ~ ~ ~ ~ a ~ i ~ i u i ~ s " a ~ l u ~ ~ u a

:. 4.3 {wlu%auuuuflaml6on UR%' certificate of analysis ( f i ~ 1 ~ h 5 1 ~ ~ 1 5 ~ 1 ~ E l 3) ~ U Q ~ U W ? O ~ I ~ U I

.oinu%w~uirlm a~0uaa~n~a~d~a~uiu~151~i5~~~"11iuZu?vud~aau <.d "

4.4 w a m ~ ~ ~ a o u ~ a ~ ~ u ~ a n i i ~ d y a a n m ~ ~ ~ i u ~ ~ a au~~au~os1~~oziicafaa~undib~u~~u~61.~. . . win! v ,. .Kt: d1~<d7u~unimmaw f~uosih ioa&a~u~mSud1~'~1oi t luna~~~1~ ' . . .

. . . . .

4.5 ~md~m~rrioa~~u'p!(ilni~ecGm (~atch or ~ o t ) ri%~afi~$wcl ' ..

. . . . . . 4.6 a ~ a n ~ ~ ~ a u a u h ~ n ~ ~ ~ ~ u ~ a i 3 ~ ~ n " m ~ Z m i ~ ~ ~ ~ n 1 ~ ~ ~ K ~ ~ d 1 a a i M " 1 n ~ ~ n ~ a f 0 ~ i n i ~ t ' ~ a ~ u d 5 a ~ u

. . . . . . . . . . . . . . rnmaums~irlm8n~s"p ~ 1 ~ m i m n a o u ~ ~ o s Z o ~ 6 ~ ~ ~ ~ ~ ~ a i % l ~ ~ o " i ~ w ' 1 u n 7 f j ~ ~ n a ~ . . . . . 65siq BS

. . . . . . ~ ~ L ~ ~ ~ Q ~ I C U ~ % ~ ~ ~ ~ Y G ~ I ~ ~ W I U ~ P I I ~ . . . . . . .

' - 4.7 ~ ~ m m ~ u ~ i ~ ~ ) i @ . i r ; i ~ u n ~ 1 2 . d c i u n m i u i ~ q ~ , . . .

. , : ~ 'Y P 1 t: 4 : .:' . 4.8 ~UJ~~ IU~~~~~~JKUA~IU~I u ~ z i ~ u n i ' ~ 1 u ~ ~ ~ ~ 1 ~ ~ i n ~ 5 a a i ~ ~ ~ a m (original wiuuu . . . . . . . . . . .

. . . . Y P . U P 4 . u . , . . . . . . . .

rmins~~doiiuci i , ~ o t number . . u~GM@&.. ~ k % ~ w t q a a n a u u a ~ ~ashl4a a u n ~ ~ m q . , :, . . . . . : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .:..... .: . . . 4.9 -TIU~AU%~? 10-25 nn&a . . . . 2 .-

. . . . . a.hntia.~ P . U R ~ ~ . I ~ ~ I I

. . . . . . . .

. ... . . . .

.

. . . . . . . . . d . : ............ . . . . . . nsm n?s

. . . . . . . . . -. . . . -(w~I.* auqunikn. . . . . . . . - . .

. . .

I50.m. - a d P I .............. naao t i . .

irrq*56 ' . " 1~.m>e2 - . . . . . . . . .

, 59-114-12: . . ' . . . . . .

. .

s 325.w): - - - , ' . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..-. . . . :. . . . . . ' . , : . . . : . . . . . . :_ . . . . . ... .:. . . : . . . . . . . . . :.. ..._. . . . . .

. .

3 . 1 ~ ~ - : &&~*d 3.2 rn : T i Cutture / Cell cuIture

: w i,!xm w m * 3.3 T i

3.4 dn-h -&itzittine powder aza~ulGil& f i S l A - q h 4. 9

h r r s

4.1 ~ ~ & v p 1 ~ 6 1 1 ~ i ~ u a = : Certificate of analysis &dbl%d%tJl v m Y ~ ~ a ~ ~ m 5 e u t ~ u ~ ) 5 ~ 1 I ~ m

42 +umm is'-& 'Matrnii 500 n f ~ (~rigind mtw&l?milr;nn~. do n ' m ~ ~ ~ m s t a ' i n ~ ~ ~ w ~ ~ a a ' ~ o x i c i t y test doma61 b i a ~ ~ i o h ~ m l i ~ ' a t ~ a a ' & a ? ' u n 7 5

43 ~srhI~&b~n3'i:~~61 (Batch M% Lot) ~ ~ m r i u ~ . t ~ u ~ u a z i ~ ~ ~ 1 5 ~ 6 1 & m ' ~ 6 1 ~ ~ 7

4.5 2 iS hm'd;~mu Y e --

4.6 ~hu5spmm1~q~t& (O@nat packing) in'&

. w .-._--..-.,._.- "r.. . a c - J m a u i p -

j . , , - - .... ---- -:------ i.. ................. c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..: ............... -, . . . . . . . . ! . .. '

3.1 ~ l 5 f i : cell culture / ~ i s u e h e

3 2 Potency: r19,000 Mmg (on Dijed basid I

3.4 Specific optical rotation : - 65. - T

3.5 Characters ' : d a a t m m i t w i i t e ~ a w d e r I

3.6 Loss on dryihg : a 35%. . . I I ,

3.7 . . sulpfmte . . : l a g - iao % I

, 3.8 Sulphated Ash : a 1.096 I .

3.10 Related Substances : Any : s 4.0%

: T a w : s 23.096 . . I

.4.1 ~~auas~n~r io~uuuunmm~~a~ ras e t e d analysis (muCa 3) siuaGuw5lad.t~mwn -u ' u~nju7n6arndaw- 9 Y - = ~ m ~ u ~ l c u a ~ 1 ~ ~ t u i " u ~ u a 5 1 ~ ~ .

4.2 ~ ~ a u s s ? ~ ? i t z ~ so0 n h (&@iit packing) f i ~ f l 1 ~ 5 ~ f l n ? a d n " i ~ l b h nmn ~asunl5 t~ iwi r J I I r a ' a ' a @micity test ~ L I A Q IRU<ZI~OJ W U R ~ ~ U ~ ~ L W ~ ~ ' & ~ W ~

u ~ d ~ G u u n = : ~ ~ a ~ * assay) lQtm~It~n~maaau 45 % e.J u

43 n ~ ~ ~ i s m i i a t 4 ~ , 1 a ? m m w & 6 a a ? i ~ ~ f a ~ i~u~an8w%vaan- rrg I R U ~ ~ ~ R ~ * ~ F N S ' F N & ~ W ~ - ~ 7 iila' d h t ~ t ~ n ~ m 6 t a i ) ~ ~ ~ ~ ~ u a ~ ~ ~ ~ h ~ ~

aon67t~+-vrua

4-4 5 ~ ~ ~ ~ ~ 1 ~ (EqSiy hte) a&-g . .

4.6 ~7$f&himh~~f t15~~~ (Batch w% tOt) t f t~w~6; l~~u-~n 'u

3.6 Sulphated ash r 1.0%

4: Gahmm& . .

4.1 ~ ~ ~ I I A ~ S ~ J U U U U ~ & &a c-ta te analysis ~ h " s a d ~ i u ~ w a

up*:* m ' d a - 0

" .I Y ~ Y ~ ~ t m ~ m w ~ l u ? ' ~ a ~ m

4.2 ~ I ~ ~ A $ & ~ ~ D ~ I ~ I Z L ? B ~ $ ? W ( I ~ W ? V 1M ?f?%

( w n a t pcking) i ~ ~ ~ ~ t i i r 1 1 x & w i ~ a s i ~oxicity test dai~laB ler&Uh B I I ~ ~ ~ ~ ~ L ~ B ~ & u ~ ~ ~ ~ , ~ ~ ~ u j a i m (Miiobid09icai asay$l&m

I I 2 a p I icvm bromide or 2-Brom&h~m-ne hy9kohmicfe (B&Q

kt- 9 -

. .I 4.4 ~ 4 u u ~ ~ ~ ~ ~ ~ ' i ~ ~ ~ ~ (originaL pa&@"$ ~ 6 7 6 ~ k W S i h l v ~ 8 ~ l . 6 7 Lot number

Q I D P umipm pk-ami@u% h961b=:&3~%0a7q "

4 5 t ~ Y m ~ * & (Batch njo Lot) $urn'-

4-6 6- Y IaiGArh 2 9 r?vPmiLA~au 4.7 n n n m g so0 flwlm* 4.8 d m Y =Iu- 44 Y

' " i a-d~ndm o.w& 0 104

1. ;a kfuulun~iua~uol vl?d%%aulsbs~ou~~<ua~uol (Sodium bicarbonate or Sodium hydropen carbonate)

2. ~ n w ~ ~ & a 1 d $ua1srflii$~unlsrm~uuZ~u~Lfl~~7'yT~ubw7sI~uqL~aa' uaa$'a12~ 3. 6'nwmzrowi,u

3.1 . ~ @ 1 5 b d : NaHC03 U , .

3.2 41au"nh~aqa 84.01 ~/Mo[

3.3 ~ ~ u i a ~ ~ ~ ? u l ~ u a ~ u Biopharrnaceutical production R I W . ~ ~ Ph Eur, BP, JP, USP

3.4 R?IUU?~MB : l r ihni? 99.5%

3.5 ~daim~upiplaa8du~$au (impurities) gaqm'ld~iu~daldd 3.4.1 Cl 0.015 - 3.4.2 Fe 0.002

3.4.3 Heavy metals (as Pb) . 0.0005 . .

3.4.4 loss on drying s 0.25 . .

. . . 3.4.5 AS 0.0002 3.4.6 504. . 0.01. . . '

. . . . - 3.4.7 .Endotoxins s 2.5 IU/g .. . .

4 . & I ~ M U R & J 7 4.1 ~ ~ u n n ~ i 6 a a u u u u ~ m m i ~ a n uaa certificate of analysis (mluca 3) 6uafluw'so&u1o1n

4 U v 4 u s w n t ~ a m ? a u m d a u a ~ ~ 5 = : ~ ~ ~ 5 ~ ~ ~ n ~ ~ u a ~ ~ f i ~ u ~ ~ ~ a ~ ~ u iau051fi1Pu~uiaua51fi1

. 4.2 (~auann~k~dasl ior i~a (~miSuan'uiYu cerfifiete of analysis $0 4.1 uiviin15nsaw b h h u d i 25 nIan% (original packaging) mu~u'isusnamddlaum ~+Laalhqisnmaou 45 ?u wanimnaou~o~8uion2nd~oanmd~sr"mi ~~aus~~m1ozEliaioa~?und1~~0~11udo~6u~aP~1 7

d 4 216 ain~d1~~41uluni~nm~1au ~ ~ a u ~ i ~ i ~ s ~ a a ~ ~ u f a a n ~ i t + i ~ u n ~ n m ~ u M ' ~ w % ~ n 4.3 ~ U ~ ~ W ~ R V ~ ~ ~ ~ ~ Q U ~ U ~ D Q I ~ U ~ F I ~ I ~ W ~ ~ (Batch ~ 1 % Lot) duaiYg~.jmrr

. . 4 u v 9 .

4.4 . @ J I E I ~ ~ U . U certificate of analysis (cmqn'i~umsmiu$a 3) &a~ua?ad1~uio1nu5wngua~ d .

c l w ~ d a ~ ~ u ? ~ u ~ u d ~ u ~ u u a = : ~ ~ o ~ m ~ ~ ~ a a u ' ~ a ~ ~ o n ~ ~ ~ u ' t ~ ~ ~ ~ ~ ~ u ~ ~ ~ n ~ a a u 45 iu. ' . .u . d V '

. . '

, . w a n ~ m m a a u ~ a i 8 u i o n ~ n 8 ~ O a ~ ~ ~ v . . . . o~flaa?o~~undii~uhiu~"soI6~u'a~m d 4 s . 7. . .

. . : . . . . ~6~1ndi1ldiiutun1'5nmaou . . f~iuo~nlos6i~~~uf~a~61't~iiu~~nn%ufia,~lil. . . SO . . . . . . . . . d . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - 4.5 . L ~ U U ~ ~ ~ K ~ F ~ I ~ I ~ ~ Q I U W " F I $ ~ %a . ' (oiiginal pa=ka$ns)~$~ihr . . . . . . . . . . .

. u n ~ ~ ~ a ~ n 5 ~ u , . aoawi? . .. . .. Lot number . . . . . .'.

. . P u v . 9 4 - 4 . U . ' . . . . . . . _ ./ .,.

. . % . . : .. ~ 5 ~ 1 ~ g ~ a ~ ~ . - ~ - 5 ~ ~ $ & 3 m iuwnm u a s ~ ~ _ s _ ~ a u m ( i l ~ l y i ; , .......................... : ........~~..... ;:. +..- +- ;--. :--- -- - .----- . . . . . . . . . ... . . .~ . . . u . . , : : . .,?. . , ~ . . .. . . . . . . . . . . . . . . . . . . . . . . . . .

: . . .. . : . . . : 4.6 6 i ~ ~ . 1 " U ~ U 9 1 m u , ~ ~ E ) 8 n ~ 7 2 3 <uqqmuaquau: . ::. .. ::'.,. : . . . . . . . . . . . . . . . . . . . . . . . ... . . , . . . . , .'. . _. .: . . . . .

. . . ' . . . . . . . / . . . . : . . . .

,. ,. ,. . . . . . . . . . . - : ::a7 v,Gmuzs?. 25-50 iilan%/ussi@aii . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . :o.u.55i?faai-t . . . . . . . . . .

. . , . . . . . . . . . . .

. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " . . .

. . . .

. . . . . . . . . . . . a+&. . . . . . . n.isUnis,..' . . . .....; . . : . . . . .

. . . . . . : . . - . . . . . . .

. . . . . - . : . . . . . ::. .

.. . . . . . . . (uquu,wqa y a h ) . :. :\.,:.:.. :.: : ' .