Chemo India Formulations Pvt. Ltd.

Plot No. 2B & 2C, Biotech Park – Phase II

Lalgadi Malakpet, Hyderabad 500 078 (India)
Tel: +91 40 33889797
FINISHED PRODUCT RELEASE SPECIFICATION
Name of the Product: Dabigatran Etexilate Capsules 150 mg Page 1 of 2
Code: Stage: FP (Release) Effective date:
Specification No: NA References: NA

Method
S.No Tests Specification
Reference
White cap and white body size 0 HPMC
01 Description capsules filled with mixture of white to -
yellowish white pellets.
The retention time of the major peak of
Identification the sample solution should correspond to
-
a) By HPLC that in the chromatogram of the standard
solution as obtained in the assay
02 The principal spot of the chromatogram
obtained with sample solution should
b) TLC correspond in position and intensity with -
that in chromatogram obtained with
standard solution.
03 Water content (by KF) NMT 4.0 -
04 Capsules average net weight (mg) ± 4.0% (371.95 - 402.95) -
05 Average 10 capsules fill wt (mg) ± 4.0% (463.15 – 501.75) -
06 Lock length 21.7 ± 0.3 -
Uniformity of dosage units:
07 AV NMT 15.0% EP
(By weight variation)
NLT 80% Q of the labelled amount of
08 Dissolution test by HPLC Dabigatran Etexilate (C34H41N7O5) is
dissolved in 30 minutes
Assay by HPLC
Each capsule contains
Dabigatran Etexilate mesylate 95.0 – 105.0
09 -
equivalent to Dabigatran (142.50 – 157.50)
Etexilate(C34H41N7O5) in mg
(%) Labelled amount
Residual solvents
a) by GC
10 Content of Isopropyl Alcohol NMT 5000 ppm -
Content of Isopropyl Methanol NMT 5000 ppm

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Chemo India Formulations Pvt. Ltd.
Plot No. 2B & 2C, Biotech Park – Phase II
Lalgadi Malakpet, Hyderabad 500 078 (India)
Tel: +91 40 33889797
Finished Product Release Specification
Product Name: Dabigatran Capsules 150 mg Page 2 of 2
Code: 4004 Stage: FP (Release) Effective date:
Specification No: 4004/SPC/01-00 References:
Method
S.No Tests Specification
Reference
Related Substances*
Deshexyl Compound NMT 1.0 %
Methyl Carbomate NMT 0.2 %
Ethyl Carbomate NMT 0.2 %
11 -
Amide Compound NMT 1.0 %
Despyridyl Ethyl Ester NMT 0.2 %
Highest unknown impurity NMT 0.2 %
Total Impurities NMT 1.5 %
Microbial test:
- Total aerobic microbial count NMT 103 CFU/g -
12 - Total combined yeast molds NMT 102 CFU/g
count Should be absent
- E. coli

*Proposed in-house specification (considered v-ensure stability specifications)

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Date : Date : Date :