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41354-29-4 Cyproheptadine hydrochloride Cyproheptadine hydrochloride sesquihydrate
Product name:Cyproheptadine Hydrochloride
Other name: Cyproheptadine HCl
specification: 99%
Test: HPLC
Appearance: white powder
MF: C21H22ClN
CAS No.: 41354-29-4
EINECS No.: 213-535-1
Items |
Acceptance criteria |
Results |
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Character |
Appearance: White or almost white powder. |
complies |
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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 |
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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% |
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