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COMPANY NAMEGeneral Testing Procedure

Title : DESCRIPTION OF MATERIAL

Supersedes : Nil Issue Date 10/04/2010 Review date April 2012

SOP No : GTP-10001 !!e"tive date 10/04/2010 Pa#e $u%&er 1 o! 1

O!ecti"e: To la' dow$ a pro"edure !or Des"riptio$ o! raw %aterials ( !i$is) produ"ts*

Sco#e: T)is pro"edure is appli"a&le to all i$"o%i$# Raw %aterials+ I$-pro"ess a$d ,i$is)edprodu"ts o! o%pa$' Na%e*

Res#onsiilit$: %& C& C'e(ist ) %& C& Manager

Procedure:

Ta.e a&out 10#% o! t)e su&sta$"e &ei$# ea%i$ed i$ a dr' Petri dis) or disperse o$ aw)ite "ard* Note t)e olour+ Odour+ s)ape a$d )o%o#e$eit' o! t)e sa%ple*

)e". !or t)e prese$"e o! a$' !orei#$ parti"les*

Ra* Materials: -10 #% sa%ples ta.e$ i$dividuall' &' ea") "o$tai$er ( visuall' ea%i$ed !or:

Appeara$"e o! powder

olour o! powder

Odour o! powder

Ca#sules: Twe$t' ar&itraril' sele"ted "apsules are visuall' ea%i$ed !or:

Appeara$"e o! "apsules

olour o! &od' ( "ap

Pri$ti$# %atter o$ "apsules

Appeara$"e o! !illed %edi"i$e

olour o! !illed %edi"i$e

Talets: Twe$t' ar&itraril' sele"ted ta&lets are visuall' ea%i$ed !or:

Appeara$"e o! ta&lets

olour o! ta&lets

S)ape o! ta&lets

oated/u$"oated ar.i$#/Pri$ti$# o$ ta&lets

Oral Li+uids: Te$ ar&itraril' sele"ted &ottles are visuall' ea%i$ed !or:

Seali$# o! &ottles*

ea.a#e i$ &ottles

a&els o$ &ottles

Appeara$"e o! S'rup / Suspe$sio$

olour o! S'rup / Suspe$sio$

Title : SOL,-ILITY TESTING

Supersedes : Nil Issue Date 10/04/2010 Review date April 2012

SOP No : GTP-10002 !!e"tive date10/04/2010

Pa#e $u%&er 1 o! 1

De"elo#ed -$ : Re"ie*ed -$ : Aut'ori.ed -$ :

Na(e: Na(e: Na(e:Designation: %A O//icer Designation: %ualit$ 0ead Designation: Managing Director

Signature: Signature: Signature:

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COMPANY NAMEGeneral Testing Procedure

O!ecti"e: To la' dow$ a pro"edure !or solu&ilit' tests !or raw %aterials*

Sco#e: Deter%i$atio$ o! Solu&ilit' i$ raw %aterials to e$sure t)e supplied %aterial passest)e pres"ri&ed tests*

Res#onsiilit$: %& C& C'e(ist ) %& C& Manager

Procedure: Solu&ilit' o! raw %aterials are to &e deter%i$e at a te%perature &etwee$ 13 a$d23 wit) !ollowi$# %a$$ers:

ei#) t)e su&sta$"e &ei$# ea%i$ed as per t)e ta&le #ive$ &elow a$d tra$s!eri$to a "lea$ a$d dr' test tu&e*

Ta.e a&out 1 # o! sa%ple i$ test tu&e / volu%etri" !las. 5as appli"a&le6* Sele"t t)esolve$t as per spe"i!i"atio$* 7ased o$ t)e solu&ilit' o! t)e sa%ple+ add t)e re8uiredvolu%e o! t)e parti"ular solve$t5s6 as per ta&le #ive$ &elow* S)a.e well to dissolvee$suri$# t)at t)e test is "arried out at a te%perature &etwee$ 203 to 903*

Add pres"ri&ed volu%e o! t)e solve$t+ s)a.e well+ so$i"ate i! $e"essar'* O&servet)e solu&ilit'*

A s%aller dilutio$s %a' &e ta.e$ !or "ostl' produ"ts*

)e". t)e solu&ilit' o! t)e sa%ple a#ai$st t)e spe"i!i"atio$*

Test %uantit$ ta1en /or test

2er$ solule 3 4 g( in less t'an 4(l

Freel$ solule 3 4 g( in 4345(l

Solule 3 4 g( in 45(l365(l

S#aringl$ solule 3 5&4g( in 6(l345(l

Slig'tl$ solule 3 5&4g( in 45(l3455(l

2er$ Slig'tl$ solule 3 5&4g( in 455(l34555(l

Practicall$ insolule 3 5&4g( in (ore t'an 4555(l

Title : CLARITY OF SOL,TION

Supersedes : Nil Issue Date 10/04/2010 Review date April 2012

SOP No : GTP-10009 !!e"tive date 10/04/2010 Pa#e $u%&er 1 o! 1

O!ecti"e: To la' dow$ a pro"edure !or "larit' o! solutio$*

Sco#e: Deter%i$atio$ o! "larit' o! solutio$ i$ t)e raw %aterials to e$sure t)e supplied%aterial passes t)e pres"ri&ed tests*

De"elo#ed -$ : Re"ie*ed -$ : Aut'ori.ed -$ :

Na(e: Na(e: Na(e:Designation: %A O//icer Designation: %ualit$ 0ead Designation: Managing Director

Signature: Signature: Signature:

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COMPANY NAMEGeneral Testing Procedure

Res#onsiilit$: %& C& C'e(ist ) %& C& Manager

Procedure: I$to separate %at")ed+ !lat-&otto%ed test tu&es+ 1 to 2 %% i$ i$ter$al dia%eter

a$d o! "olorless+ tra$spare$t+ $eutral #lass+ pla"e su!!i"ie$t o! t)e solutio$ &ei$#

prepared 5e*#*1#% i$ 20%l water6 a$d o! t)e appropriate re!ere$"e suspe$sio$+

!res)l' prepared as p)ar%a"opoeia+ su") t)at t)e test tu&es are !illed to a dept) o!

40 %%* ,ive %i$utes a!ter preparatio$ o! t)e re!ere$"e suspe$sio$+ "o%pare t)e

"larit' i$ di!!used da'li#)t+ viewi$# )orio$tall' a#ai$st a w)ite &a".#rou$d wit) water

or re!ere$"e suspe$sio$ I*

A li8uid is "o$sidered "lear i! its "larit' is t)e sa%e as t)at o! water or o! t)e solve$t

used w)e$ ea%i$ed u$der t)e "o$ditio$s des"ri&ed a&ove or i! its opales"e$"e is

$ot %ore pro$ou$"ed t)a$ t)at o! re!ere$"e suspe$sio$ I*

Title : COLO,R OF SOL,TION

Supersedes : Nil Issue Date 10/04/2010 Review date April 2012

SOP No : GTP-10004 !!e"tive date 10/04/2010 Pa#e $u%&er 1 o! 9

O!ecti"e: To la' dow$ a pro"edure !or "olor o! solutio$*

Sco#e: Deter%i$atio$ o! "olor o! solutio$ i$ t)e raw %aterials to e$sure t)e supplied%aterial passes t)e pres"ri&ed tests*

Res#onsiilit$: %& C& C'e(ist ) %& C& Manager

Procedure: ;si$# ide$ti"al tu&es o! "olorless+ tra$spare$t+ $eutral #lass 12 %% i$ eter$al

De"elo#ed -$ : Re"ie*ed -$ : Aut'ori.ed -$ :

Na(e: Na(e: Na(e:Designation: %A O//icer Designation: %ualit$ 0ead Designation: Managing Director

Signature: Signature: Signature:

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COMPANY NAMEGeneral Testing Procedure

Dia%eter "o%pares 2*0 %l o! t)e li8uid &ei$# ea%i$ed wit) 2*0 %l o! water or o! t)esolve$t or o! t)e re!ere$"e solutio$ pres"ri&ed i$ t)e p)ar%a"opoeia* o%pare t)e"olor i$ di!!used da'li#)t+ viewi$# )orio$tall' a#ai$st a w)ite &a".#rou$d*

T)e ea%i$atio$ o! t)e "olor o! solutio$ i$ t)e ra$#e &row$-'ellow-red is "arried out&' a&ove %et)od* A solutio$ is "o$sidered "olorless i! it )as t)e appeara$"e o! water

or t)e solve$t or is $ot %ore i$te$sel' "oloured t)a$ re!ere$"e solutio$ 7

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COMPANY NAMEGeneral Testing Procedure

C& Cu#ric Sul#'ate Colori(etric Solution 7CSS8 :

Dissolve a&out @* # o! "upri" sulp)ate i$ e$ou#) o! a %iture o! 2* %l o! )'dro")lori" a"ida$d

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COMPANY NAMEGeneral Testing Procedure

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