Product Specification Sheet

Valsartan 160mg/Hydrochlorothiazide 12.5 mg F.C Tablet

Finished Product Release Specification Sheet

No
Test Specification Reference
.
Dark red , compact, biconvex, oval shape ,
1. Description In house
embossed with A4 film coated tablets
Identification:
- The retention time of valsartan and
- HPLC hydrochlorothiazide peaks of the sample solution
correspond to that of the standard solution as
2. obtained in the assay USP

- TLC - The Rf values of the principal spots from the

sample solution correspond to those from the
standard solution
Av. wt. ± 5 % target wt. = 309 mg
3. Weight variation BP/EP
(293.6 – 324.5 mg)
4. Hardness NLT 40 N In house

5. Diameter 13.4± 0.2 mm In house

6. Thickness 5.0 0.2mm In house

7. Water content (KF) NMT 6.0% In house

8. Disintegration time NMT 30 minutes In house
Related substances
- Benzothiadaizine related NMT 1.0%
compound A
9. NMT 0.2%
USP
- Any other impurity
- Total impurities (excluding
valsartan impurity A) NMT 1.3%

10. Dissolution(USP-Test2) Valsartan NLT 85% (Q=80%) in 30 min. USP

Hydrochlorothiazide NLT 85% (Q=80%) in 30 min..
Valsartan : 90.0 - 110.0% of the label claim.
11. Assay USP
Hydrochlorothiazide : 90.0 - 110.0% of the label claim
Uniformity of dosage unit AV≤ L1
12. L1= 15.0
USP
(content uniformity)
Microbial contamination
- Total viable aerobic count:
13. Bacteria < 103 CFU/gm USP
-Fungi < 102 spores/gm
-E.coli Absent