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 60-80F (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




CI No.


Methyl Paraben



CI No.


Propyl Paraben



CI No.


Sodium Lauryl Sulphate



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)



Moisture (loss on drying)

12.5%- 16% w/w


Disintegration time

Less than 15 minutes


Average wt. of 100 capsules

XXX gms. +/-10%


Total microbial count for 48-72 Hrs. (35-38 C)

Less than 1000 cfu/gm.


Escherichia coli

Absent in one gram.



Absent in ten grams.


Pseudomonas aeruginosa

Absent in ten grams.


Staphylococcus aureus

Absent in ten grams.


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

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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Tel: +1-973-244-1125 USA Eastern Time * Fax: +1-973-244-1365
Torpac Inc., 333 Route 46, Fairfield, NJ 07004, USA

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