YASH PHARMACEUTICALS

Khasra No.19M, Village: Raipur, Pargana: Bhagwanpur,Tehsil– Roorkee,

Distt: - Haridwar, Uttarakhand
Department Name: Quality Control
Title: CERTIFICATE OF ANALYSIS Page No. 1 to 1
Name of Material EHG.CAPSULES OPAC RED/RED CT SIZE “0”
Batch No. 17K13 A.R. No. YRMG180702
Mfg. Date 01/2017 Batch Size 900000.000 NOS
Exp. Date 01/2022 Manufacturer SUNIL HEALTH CARE
Receipt Date 19/06/2017 Supplier G.K.PHARMA
Analysis Date 19/06/2017 Releases Date 19/06/2017

Specifications
Sr. No Test Results
Empty hard gelatin capsule shells
consist of two cylindrical telescoping
Empty hard gelatin capsule shells
pieces (cap and body). Empty hard
1 Description consist of two cylindrical, telescoping
gelatin capsule shells consist of two
pieces(cap overlaps the body and
cylindrical, telescoping pieces(cap
maintains a tight friction closure .Cap
overlaps the body and maintains a
red and body transparent ,size (“0”)
tight friction closure . Cap red and
body transparent ,size (“0”)
Identification
2
A precipitate should be produced in A precipitate should be produced in
A By Chemically each case. each case.

The shells do not develop any foreign The shells do not develop any foreign
3 Odour
odour. odour.
The average weight is within ±10
4 Average weight
percent of the target weight(0):96 mg 93.97mg
Disintegration NMT 15 minutes, using discs 7 minutes
5
time
12.5 to 16.0 percent ,determined on 1.g 14.65%
6 Loss on drying by drying in an oven at 105ºC for 4
hours or to constant weight
Less than 103 CFU per g.
Total microbial count is not more than Absent ( Escherichia coli),
Microbial
7 103 CFU per g. 1g is free Escherichia Absent (shigella)
contamination
coli and 10g is free from salmonella and
shigella

Opinion: The Sample Complies/Does not comply with IP/BP/USP/IH Specification.

Prepared by Checked by Approved by

Sign:
Date:

Format No.-YPR/QC/003/F08-00