we have gmp cep usfda dmf and writtern confirmation ,it conforms the usp37/ep7.0
character |
white or almost white, crystalline powder |
identification a |
optical rotation |
identification b |
melting point of base :171℃~176 ℃ |
identification c |
ir test |
identification d |
copper sulphate test |
identification e |
chloride reaction |
acidity or alkalinity |
complies |
appearance of solution |
clear |
|
colourless |
melting point |
about 143℃ |
specific optical rotation |
- 43° to – 47° |
related substances |
impurity c、e≤0.1% |
|
unspecified impurity≤0.10% |
|
total impurities ≤ 0.2% |
sulphates |
not more than 500 ppm |
loss on drying |
not more than 1.0 % |
sulphated ash |
not more than 0.1 % |
assay |
98.5 to 101.0 % |
particle size |
98% past 40 mesh |
residual solvents |
methanol ≤3000 ppm |
|
2-propanol ≤5000 ppm |
|
ethanol ≤5000 ppm |