Quality Control Department

NovaMed CERTIFICATE OF ANALYSIS

Pharmaceuticals Finished product
(We Care for Better Life)
QC/DOC/028
COA No. FP Next-011

Product: Amper 5-4mg Tablets

Generic name: Amlodipine+Prindopril ter.butylamine
Composition: Each tablet contains: Amlodipine(as Besilate) 5mg and Perindopril TBA 4mg.

Batch No: 6905 B. Size: 120,000 tablets D.R.: 069158

Mfg. Date: 09-14 Exp. Date: 09-16 Date of Analysis: 10-10-14
Stage: Finished Q.C.#:QC/FP-Next-011/T-14-TB-181 Pack Size: 1x10s

Sr.No Tests Specifications Results Conclusion

1 Description An alu alu blister containing a
white colored, biconvex film Complies Conform
coated tablets,both sides are
plain, packed in specific U/C
along with leaflet.
2 Identification The retention time of the
(Prindopril ter. prindopril ter.butylamine peak in
butylamine) the chromatogram of the assay Correspond Conform
preparation corresponds to that
of the standard preparation
obtained as directed in the assay.
3 Identification The retention time of the
(Amlodipine) Amlodipine peak in the
chromatogram of the assay Correspond Conform
preparation corresponds to that
of the standard preparation
obtained as directed in the assay.
4 Avg wt of 20 tablets 137mg-145mg 140.5mg Conform
5 Disintegration time NMT 30 min 4-6mins. Conform

6 Assay 90—110% 101.99% Conform

(Prindopril TBA)
7 Assay 90—110% 100.27% Conform
(Amlodipine)
8 Blister leakage test TO Comply Complies Conform

9 Packaging TO Comply Complies Conform

Components

Remarks: The product complies the INH specifications.

Proceeds For: Dispatch
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ANALYST QUALITY CONTROL MANAGER