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10 Gram |
Negotiable |
Cyproheptadine hydrochloride price Cyproheptadine hydrochloride supplier Cyproheptadine hydrochloride factory
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% |
|||
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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