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Test Item

Specification

Method

Result

Description

White or almost white crystalline powder or colourless crystals

visual

White crystalline powder

Identification

Infrared absorption

Consistent with the reference IR spectra

USP

Consistent with the reference IR spectra

Chloride

A white curdy precipitate is formed with silver nitrate, the precipitate is insoluble in nitric acid but dissolves readily in ammoneia

A white curdy precipitate is formed with silver nitrate, the precipitate is insoluble in nitric acid but dissolves readily in ammoneia

Appearance of solution

Clear, not more intense than Y7

EP

Clear, not more intense than Y₇ 

PH

2.7-3.3

USP

3.0

water

NMT 5.0%

USP

2.0%

Sulphates

NMT 0.03%

EP

＜0.03%

Residue on ignition

NMT 0.1%

USP

0.06%

Absorbance of solution

NMT 0.025

USP

0.009

Limit of nitrate

No brown ring

USP

No brown ring

Related substances (disregard limit :0.05%)

- Impurity A

NMT 0.15%

EP

0.02%

- Impurity B

NMT 0.3%

EP

0.01%

- Impurity C

NMT 0.15%

EP

0.01%

- Unspecified Impurity

NMT 0.10%

EP

0.01%

   -Total  Impurities

NMT 0.5%

EP

0.12%

Related compounds

NMT 1.0%

USP

0.04%

Residual solvent

  Methanol

NMT 0.3%

GC,in-house

＜0.3%

  Ethanol

NMT 0.5%

GC,in-house

＜0.5%

Assay（on anhydrous basis）

98.5%~101.0%

USP

99.3%

Conclusion:

This batch complies with the specification of BP2020/USP 42

Remark: Preserve in a tight non-metallic container, protected from light. Please consume the product within a short period once opened.