Cyproheptadine hydrochloride 41354-29-4 Periactin
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Other name: 4-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine
CAS NO.: 41354-29-4
EINECS NO.: 213-535-1
MF: C21H21N.HCl
MW: 323.86
InChI: 1/C21H21N.ClH.3H2O/c1-22-14-12-18(13-15-22)21-19-8-4-2-6-16(19)10-11-17-7-3-5-9-20(17)21;;;;/h2-11H,12-15H2,1H3;1H;3*1H2
Appearance: white crystalline powder
Standard: CP/BP/USP/EP
Odor: odorless
Specification:
Items |
Acceptance criteria |
Results |
||
Character |
Appearance: White or almost white powder. |
complies |
||
Solubility: Slightly soluble in water, freely soluble in dilute acetic acid and in methanol, slightly soluble in alcohol. |
Complies |
|||
Identification |
A.Specific optical rotation: –30.0º~-33.5º (dried substance) |
–33.3º |
||
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% |
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