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Cyproheptadine Manufacturing United Kingdom and USA
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Cyproheptadine

  • Product Name : Cyproheptadine
  • Grade : IP / BP / USP
  • Therapeutic Category : Antihistamine
  • CAS No : 41354-29-4
  • COA : Available
  • MSDS : Available

Description

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:

 

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

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

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

The product meets the specification

         

 

 Packaging details:

 

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.

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