Cyproheptadine hydrochloride 41354-29-4 C21H22ClN
items |
acceptance criteria |
results |
||
character |
appearance: white or almost white powder. |
almost white powder |
||
solubility: slightly soluble in water, freely soluble in dilute acetic acid and in methanol, slightly soluble in alcohol. |
complies |
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identification |
a .specific optical rotation: –30.0º~-33.5º ( dried substance ) |
–33.3º |
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b. infrared absorption spectrophotometry: the ir spectrum is consistent with that obtained with levodropropizine crs. |
complies |
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tests |
ph |
9.2~10.2 |
9.4 |
|
impurity b and related substances |
impurity b: ≤ 0.5 % |
≤ 0.1% |
||
any other impurity: ≤ 0.1 % |
≤ 0.1% |
|||
total impurities: ≤ 0.6 % |
≤ 0.1% |
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impurity c |
≤ 5 ppm |
≤ 5ppm |
||
enantiomeric purity |
impurity a: ≤ 2 % |
0.2 % |
||
loss on drying |
≤ 1.0 % . |
≤ 0.1 % |
||
sulphated ash |
≤ 0.2 % |
≤ 0.1 % |
||
assay |
98.5 % ~ 101.0 %( dried substance ) |
99.7 % |
||
conclusion |
th e product meets the specification of ep 7.0 |
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