Test Item

Specification

Result

Appearance

white or almost white crystalline powder or colourless crystals

White crystalline powder

Identification

(1) should be positive reaction

(1) positive reaction

(2) Consistent with the reference IR spectra

(2) Consistent with the reference IR spectra

pH

6. 8-7. 5

7.2

Appearance of solution

clear,not more intense than Y7

clear,not more intense than Y7

Heavy metals

NMT20ppm

<20ppm

Chloride

NMT600ppm

<600ppm

Loss on drying

NMT 1.0%

0. 2%

Residue on ignition

NMT 0. 1%

0. 08%

Residual Solvents

--Methanol

NMT 0. 3%

<0.3%

- -Ethanol

NMT 0. 5%

<0.5%

Related substances (Disregard limit 0. 05%)

--Impurity A

NMT 0. 15%

0.12 %

--Impurity B

NMT 0. 6%

0.01 %

-- Impurity C

NMT 0. 4%

0.01 %

—Any impurity

NMT 0. 1%

0. 03 %

--Total impurities

NMT1.0%

0. 26%

Assay

98. 0〜101. 0%

99.6%

Conclusion:This batch complies with the specification of BP2020/USP43