- E-mail : info@fortunebiopharm.co.uk
Cyproheptadine is used to treat allergic reactions (specifically hay fever). It is also used to treat vasomotor mucosal edema, including vasomotor rhinitis and edema of the throat.It has shown effectiveness in the treatment of nightmares, including those related to post-traumatic stress disorder.
Specification:
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Items |
Acceptance criteria |
Results |
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Character |
Appearance: White or almost white powder. |
Almost white powder |
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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 |
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Impurity B and related substances |
Impurity B: ≤ 0.5% |
≤ 0.1% |
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Any other impurity: ≤ 0.1 % |
≤ 0.1% |
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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 % |
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Loss on drying |
≤ 1.0 %. |
≤ 0.1% |
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Sulphated ash |
≤ 0.2 % |
≤ 0.1% |
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Assay |
98.5% ~ 101.0%(dried substance) |
99.7% |
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Conclusion |
The product meets the specification |
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Packaging details:
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Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
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Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
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Shelf Life: |
5 years if sealed and store away from direct sun light. |
