.iiiiii4:*$"&i,*f$* i.:i;;.;r,,+io;+.

@ Lee Plrarr- r-r-rzr t-inriteci

F:rctorS': S1'. No. IOlC-1. Gaddaporhlrarrr \/iliir-lc. Jirutrrar;r Nlarrdel. l\,,1cdak Dist, I,ir: coclc:-502jlg,
i\niiltrl l)rn.iuslr. inLlir
ffir
M\ Factory,: +9 l-0E.15S-177i I I/l-5 I Oi'irccr:, 9 I -.10-661 70jj_i/316
, CtrRTIii'IC.\'fli Oir AN;\LYSIS
Montclukast soclium lP tuVs.,qril-
Pharmaceuticils.
Batch No, MKrPt3004 / D;iic of jvlanuficturr Jan..20l 3

i,tl^t, Datc oI Il.etcst Dec.2015

A.R.No. : i CBI3064 osb*ot) Datc Analvzcd 04.02.20l.l
R.cfcrencc .Spccillcatiorr No. SN,fI(FPO!
Store protcctcd from-lighr anci Dispatcir Quantitl,
nloisttlrc. at a lcnlpcralurc nL)t
cxcccdinc.30"

t*r TIiST IUTSUL'r' if SPUCI|IC.ATiON

I

@--i;rmi
I

:'l
Irrcc);, solublc in rnclha-rrol,
liccl,v solublc in \\'f,icr,
solrrblc in c[]ranol (95%)
ancl i)ractic;ri insoiLrblc irr insolublc in acetoniiriic.
ilcctoil iirilc.
I
i

Idcntificr in I
I

r. i ijy ii The iR .slicct.runl o1' slrnrpJu j 't'hc

'l'hc II
IIt slcctrunr ol'snntpic
is coiicordent to thrt ol lsll0ul(
I
shorrld i:c cclncoldtlll tu ihill
I
o1:
rvo.rkir:t standlrtl. rvirrkirtgt s tandlrrcl.

Bi I{. C Thc'rclcnt ion ririt.
principrii pc;rk cbilirrrd
sanrl:lc soi iri iorr i:^
concord;urt 1\'lrii iittl oi
tvorkir:g stanijtrd.
o.l' Lhc Thc rcrcniion iitre o1:ilic
irr principrrl jreflk (lbta;iicd in sarnpJc
soltrtion sirould be concordant'
'
rriiir tIrai cil:,,r,orking siai:r<iar,j'.

r.J I cst i Sl:all gir"c poiiitivc ttsi lor

sodiLrnt.
Water cor rt by KF (9'0, rr/rr') Not nrore {iran 3-0
L
Heavy n:c :; fttpnr) No{, mr:rc llrun 20 I

I'

Spccitic o: :al rotarion (o) Bclrvccrr +95.0 and -i-106.0 i

Prcprrcd b!:_,.-.;
Dotc: ,!ar- ,-f \o-t\r1
Documcnt Format Ntr ?0{7i:0j-0? I
I
Ef'lictiveDarc:01.0.t. C :I I

d^-^ 1 ^l 1
, it.' f o\)c I ul L I
t.
l';1, i,
 @ Lee Pirarrn;) Linritecl
Factory: S_v. No. l0/C-1. Caddapolhanrrlr Vili.rgc. Jinrr;rr:rrrt N.llndai. li'{cd;rk Dist, l'irt codc:.5021 1r,
.i itrlltr:r I'r:rr.lcsl:. Irrii i:i.
-@l..
Ell ) 1 /25 I Otl rce; ), l -4 () -66 I 70j j j/il
l:'actorJ': +9 1 -0.145 S-:;/ 7 1 6

CIr tlTIi;, C'z\l'I'l OF r\ Nr\l-\'SIS

lvlontclukiist sodiur:r II) i
I
Clu-storrrcr nanrc Iv{/s. Aril
Phanrraccuticals.
_.::,., -."' IvIKFP 13004 Drrc of i\4anufacturc Jan. 20li
,.:rl.r,Gla-.
{ . lr 'l
ii' *, ' 33.1 Ks .-\ Datc of Retest Dec,2A15
c)l
l, . .i..
cB I306.1 Datci\nalr,';,.cd _f 04,02.20I i
t.
ri.'rliiir'
".: IP Spcciilcaticn No. I Si"[iiirP0 i
,l: ,
St*" p6i;"t""1 ftr,, irjili,,*l i)i.sp;rtch Quurtitl, I5.0 Kg
moisturc. at a tcmpcrsturc Itot
:
:'ii.
,.'
cxcccding 30o

TtrST RI'SULl'
Rclatcd substances by FIPLC (%)
7.1 montclukast sulphoxidc Not nrorc tlran 0.3
72 montclukast sl,yrenc 0.05 Not nrorc than 0.3
7.3 Single maximun impurity' 0.05 Nol nrore than 0.3
7.4 Total imouritics u. /d Not nrore than 1.0
Assay by HPLC (Yo, w/w) i.iot icss tiran 98.C anC :rot nrore
(On anJrl,drous basis) tban 102.C)

The

. \.d,

Iic vicrvcti
'**"yAy-,\o.\r>
Darc: /----' C'
Documcnt Format No. LQ017ij0l-01
Effectivc Datc: 0 1.0.1.20 I 0

Page2 of 2
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