PARAMETERS

USP

SPECIFICATION

RESULT

REMARKS

Description

Colourless or white crystals or crystalline powder. Usually having a slight odour of trimethylamine. Clear and?colourless in solution . Hygroscopic.

Solubility

Soluble in alcohol and in water.

Identification

A: Infrared absorption <197K>

B: Test of chloride <191>.

pH < 791>

Between 4.0 and 7.0 in a solution ( 1 in 10)

Water Method I <921>

Not more than 0.5%

Residue on ignition <281>

Not more than 0.05%

Arsenic Method I <211>

The limit is 2 ug per g

Lead <251>

Not more than 0.3 ug per g is found

Heavy metals Method II<231>

The limit is 0.001 %

Limit of total amines

Not more than 0.001 % is found

Chromatographic purity?(HPLC)

Not more than 0.3 % of any individual impurity is found , and not more than 2.0 % of total impurities is found

Organic volatile impurities Method IV <467>

Meets the requirements, except that the limit for 1,4-dioxane is 10 ug per g

Assay

Not less than 99.0 % and not more than 100.5 % calculated on the anhydrous basis