ITEM

SPECIFICATIONS

RESULTS

Characteristics

White or almost white crystalline powder or colourless crystals

white crystalline powder

Identification

Corresponds

Corresponds

Melting point

189℃~193℃

191℃

pH （5%，W/V）

2.1-2.6

2.28

pH （2%，W/V）

2.4-2.8

2.48

Specific optical rotation

 +20.5°－+21. 5°

+20.9°

Apperance of solution

Solution S is clear and not more intensely cloured than reference solution BY7

Up to standard

Heavy metals

≤10ppm

＜10ppm

Assay

99.0%-100.5%

99.2%

Copper

≤5ppm

0.21ppm

Iron

≤2ppm

0.12ppm

Mercury

≤1ppm

0.05ppm

Arsenic

≤3ppm

＜3ppm

Lead

≤2ppm

0.07ppm

Oxalic acid (impurity E:)

≤0.2%

＜0.2%

Loss on drying

≤0.4%

0.02%

Sulphated ash

≤0.1%

0.02%

Related substances:

Impurity C

≤0.15%

＜0.01%

Impurity D

≤0.15%

＜0.01%

Unspecified impurities

≤0.10%

ND

Total

≤0.20%

ND

Residual solvents:

Methanol

≤3000 ppm

100ppm

Microbiological examination

TAMC

10³ cfu/g

Corresponds

TYMC

10² cfu/g

Corresponds

E.coli

Absence

Corresponds

Conclusion: Conforms to the standard of BP2014/USP38/E300/FCC7