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vbritas CERTIFICATE OF AI\ALYSIS Version No.:01

Product Name Asmatab 10 Tablet Product FINISHED

iEach tablet contains Montelukast 10 mg as Montelukast Sodium INN) Stage PRODUCT

Prepared by: QC O{ficer Checked by: Asst, Manager,,QC Approved by: QA Manager

Sign & Date tvl-i{si'a Sign & Date Sign & Date &"6?ru1")-
ar{}a ?,/t .4

Analytical l,.lethod Ref. No, rr/eD0a\lra Document No SPECIBD 001lFP/00

Batch Number 0L0r:: Product Code BD OO1

Batch Size ( by weight) t['lta va Batch Size (by Number) 1,7 0, rrn 1-^tlo-j
Mfg. date
fl-\'l I Receiving date 04r6blt4
Exp. date
b- l?
Vp QC re{. No. I T. L'15
Analytical Note Book re{. No A r{{\ I 0ae I i4 Date Tested c 0bl 3
Paoe No. of Analvtical Noie Book C?-/ ( < Tested by t-r

SI No. TEST SPECIFICATION

ffi
ULnntA,
RESULTS

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A white to Off white colored, round shaped {ilm coated tablet lvith -l',\-'
l-o atn lo- a lxt,
01 Description
"V" engraved on one side and other side break line t.ni+A'v" Qnlf\Ar, qrl
0n 0nz l,.'zla vA>rl
6 Nl*e nl irf o bn o-r.,1 :Ul e_

ldentiflcation Positive for Montelukast Sodium o r)i -l'iva

03.
Average weighUTablet
(ms)
92,0 mg - 102.0 mg (97.0 mg t 5 %) '1 8' S

l. Blt
04 Uniformity of weight
Out of 20 Tablets maximum 2 tablets shall deviate L7 .5% ol
average weight and none shall deviate t 1 5% of average weight * *t 5. A4',
05. Thickness 3.0 mm - 3.33 mm {3.17 mm t 5%) 'L
'1. 4 q,L
06 LOD (o/0)/Water (%) Not more than 3.5%
07. Average Hardness (Kp) Not less than 4 ,L
OB Disintegration time Not more than 30 minutes '0 rnrnu,Ar
09. Dissolution Not less than 70% within 30 minutes (8s.q\-f+.BL]."/.
10
Assay: Montelukast
(ms/tablet)
9.0 mg - 11 0 mg (90.0 % - 110.0 % of the label claim) 1' sb
(1e'
.'-&
,,

i"Y.
Packaging Type: Elister (AIu-AIu 3X10 s) Dn[cr^/q:4 yLft5 M(T 5D>Tg
11 Packaging lnformation :
Batch No, MRP: vrfi "pak: f,U-14 Fxr.pat:
Mfg. Date: Exp. Date: k tL=* t

12, Check lisl Should meet A"at ttu 91.t^'f. *l- 0t

Data compiled by: : l'ar*i1y Checked by

Date . o+labi Date
nD0ES NOT CONFORM to the requirements of the snecificati

-D*6ry.sq.t v
Sign of QA Authorized person & date