Rocuronium Bromide Api+intermediate

Rocuronium bromide API+Intermediate Specifications :
Characters Almost white or pale yellow, slightly hygroscopic powder
Freely soluble in water and in anhydrous ethanol
Identification(1)a IR Spectrum conforms with RS
(2)a gives reaction of bromides
Tests
Appearance of solu-tion Solution is clear
Solution is not more intensely coloured than reference solution BY5
pHpH8.9i 9.5
Specific optical rotation+ 28.5A i + 32.0A
Related substancesImpurity Aa 0.2%
Impurity Ba 0.3%
Impurity Ca 0.3%
Impurity Da 0.1%
Impurity Ea 0.1%
Impurity Fa 0.1%
Impurity Ga 0.1%
Impurity Ha 0.1%
Individual unknown impurity a 0.1%
Total impurities a 1.5%
Chloridesa 0.1%
Residual solventsMethylene Chloride a 600ppm
Methanola 5000ppm
a 5000ppm
Heavy metalsa 10ppm
Watera 4.0%
Sulphated asha 0.1%
Endotoxin<10EU/mg
Assay99.0%i 101.0%