Characters | White or almost white,crystalline powder or colourless crystals |
Identification | Corresponds |
Melting point | 189ºC~193ºC |
PH (5%,W/V) | 2.1~2.6 |
PH (2%,W/V) | 2.4~2.8 |
Specific optical rotation | +20.5°~+21.5° |
Appearance of solution | Solution S is clear and not more intensely coloured than reference solution BY7 |
Heavy metals | <=10 ppm |
Assay | 99.0%~100.5% |
Copper | <= 5ppm |
Iron | <= 2ppm |
Mercury | <= 1ppm |
Arsenic | <=3ppm |
Lead | <=2ppm |
Oxalic acid (impurity E) | <=0.2% |
Loss on drying | <=0.4% |
Sulphated ash | <=0.1% |
Impurity C | <=0.15% |
Impurity D | <=0.15% |
Unspecified impurities | <=0.10% |
Total | <=0.2% |
Methanol | <=3000ppm |
TAMC | 103 cfu/g |
TYMC | 102 cfu/g |
E.coli | Absence |