Betamethasone
1.CAS:378-44-9
2.Appearance: white crystalline powder
3.Quality:EP6/BP
4.anti-inflammatory agent
Function:
(1)Betamethasone is a potent glucocorticoid steroid with anti-inflammatory and immunosuppressive properties.Unlike other drugs with these effects, betamethasone does not cause water retention.
(2)It is applied as a topical cream, ointment, foam, lotion or gel to treat itching.
(3)Betamethasone sodium phosphate is sometimes prescribed as an intramuscular injection (I.M) for itching from various ailments including allergic reactions to poison ivy and similar plants.
Specification of Betamethasone
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Items
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Standard
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Results
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Appearance
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White or almost white crystalline powder
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almost white crystalline powder
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Identification (B,C)
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Complies with the Standard
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Complies
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Specific optical Rotation
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+118°~+126°
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+125.0°
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Related Substances
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-Single impurity
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Not more than 1.0%
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0.51%
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- impurity that ≥0.5%
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Not more than one
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Complies
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-Sum impurities
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Not more than 2.0%
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0.97%
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Loss on drying
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Not more than 0.5%
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0.05%
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Assay(UV, basis on drying)
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97.0%~103.0%
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99.7%
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Organic volatile substances
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Methanol
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max. 3000ppm
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Complies
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Ethyl acetate
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max. 5000ppm
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Complies
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Acetone
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max. 5000ppm
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Complies
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DMF
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max. 880ppm
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Complies
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Dichloromethane
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max. 600ppm
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Complies
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Chloroform
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max. 60ppm
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Complies
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Packaging and storage: Preserve in tight, light-resistant containers.
Conclusion: The test product complies with the requirements of EP6.
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China
