Certificate of Analysis

Certificate of Analysis

Product: Empty Hard Gelatin Capsules		Batch No.
Capsule Size		Color Code Cap/Body
Date of Manufacture		Date of Expiry *

* Five years if packed cartons stored under the following conditions: a) At 60-800F (15-250C) and 40-60% Relative Humidity, b) Away from any direct source of heat (e.g. radiators, sunlight), c) Protected from moisture.

Ingredients & Composition

Gelatin	Dye1	CI No.
Methyl Paraben	Dye2	CI No.
Propyl Paraben	Dye3	CI No.
Sodium Lauryl Sulphate	Dye4	CI No.

Gelatin and other raw materials used meet applicable US., European and Japanese Pharmacopoeia specifications for the use in manufacture of empty gelatin capsules.

Due to the nature of raw material, their sourcing and technology improvements, the colorant composition data indicated are target values and actual values may vary to insure the consistency of capsule color.

Empty gelatin capsule specification

Finished capsules meet applicable US, European and Japanese Pharmacopoeia specifications.

Finished capsules meet US Federal Standard 285A and US Federal Specification U-C-115b for acid solubility and water resistance.

Characteristics (Test)	Specification	Result
Moisture (loss on drying)	12.5%- 16% w/w	complies
Disintegration time	Less than 15 minutes	Actual
Average wt. of 100 capsules	XXX gms. +/-10%	Actual
Total microbial count for 48-72 Hrs. (35-38 C)	Less than 1000 cfu/gm.	complies
Escherichia coli	Absent in one gram.	complies
Salmonella	Absent in ten grams.	complies
Pseudomonas aeruginosa	Absent in ten grams.	complies
Staphylococcus aureus	Absent in ten grams.	complies

The capsules are manufactured under carefully controlled conditions in accordance with c-GMP. Continuous control maintained throughout the process and guarantee that capsules conform to the highest quality standard.

World Sales & Service: For further information on capsules, filling machines, dosing devices or assistance with research or other industrial uses contact :

Torpac Inc., 333 Route 46, Fairfield, NJ 07004, USA.
Tel.: 1-973-244-1125 Fax : 1-973-244-1365
www.torpac.com

This lot of capsules described is hereby certified to you.

Name: Title: Q.A. Officer

Manufactured for Torpac Inc. under exclusive contract by: Custom Capsules Pvt. Ltd., India . Manufacturing License No. KV/33.

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