Specification

Requirements

Analysis method

Characteristic

Hard gelatin capsule have cylindrical form consisting of two cylindrical sections (cap and body), both heve rounded end, one is opened the other closed. Cap and body maybe freely joined, forming seal, cap and body surface is smooth, shells are tough and elastic, even without curves edge regularly shaped, uniform color

Description

Capsules of indicated color and size in accordance with suppliers specification

visual

Visual estimation

ACC. SOP, 200 capsules

visual

Dimensions

ACC. addendum 2 or with suppliers specifications

in-house method

Capsule average weight

ACC. suppliers specifications

in-house method

Water

12-16%

Ph.Eur. 4^th ed

Disintegration

MMT 15 min

Ph.Eur. 4^th ed

Microbical contamination

Ph.Eur. 4^th ed

-total viable aerobic count

NMT 500 per 1 g of capsule mass

NMT 1000 per 1 g of capsule mass

Ph.Eur. 4^th ed

- fungi

NMT 100 per 1 g of capsule mass

Ph.Eur. 4^th ed

- Esherichia coli

Absence/1g

Ph.Eur. 4^th ed

-Salmonella

Absence/1g

Ph.Eur. 4^th ed