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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

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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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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