Index Name

Specifications

Appearance

White or almost white crystalline powder

Identification  IR

Chloride

Complies with reference spectrum

Positive

HPLC

(Chromatographic purity HPLC )

Total impurities: 0.30%max

Individual specified impurities:

A(R052699): 0.20%max

B(R052612): 0.20%max

C(R009280): 0.20%max

D(R036163): 0.20%max

E(R009978): 0.20%max

Unspecified individual impurities: 0.10%max

Appearance of solution

Clear and not more intensely colored than reference solution Y7

Loss on drying

0.50%max

Sulphated ash

0.1%max

Heavy metals

20ppm max

Specific optical rotation

-121 to -128degree (calculated on the dry basis)

PH

3.0 to 4.5

Assay

98.5 to 101.0% (calculated on the dry basis)

In-hourse specification

Insoluble matter

No substantial foreign matter is observed

Transparence %

85.0%min

Microbiological purity

Bacteria: 100CFU/g max

Fungi and yeasts: 100CFU/g max

Enterobacteriaccae absent in 10g of product

Particle size

(min.)90%  420um max

(max.)50% 75um max