Basic information of Hydrocortisone 50-23-7
- Product Name: Hydrocortisone
- Molecular Formula: C21H30O5
- Molecular Weight: 362.46
- CAS No.: 50-23-7
- Appearance: White crystalline powder
- Specifications: EP6/USP37;EP8
Usage of Hydrocortisone 50-23-7
- Treat for allergic dermatitis, eczema, neurodermatitis, seborrheic dermatitis, etc.
- Adrenocortical insufficiency and hypopituitarism.
COA of Hydrocortisone 50-23-7
SINOWAY INDUSTRIAL CO.,LTD.
16/F.,HUICHENG COMM.COMPLEX, 839 XIAHE RD.,XIAMEN,CHINA
TEL: 0086-592-5854962 POSTCODE: 361004
FAX: 0086-592-5854960 E-MAIL: sale3@china-sinoway.com
Certificate of Analysis
Product Name: Hydrocortisone
Batch No.: T2930
Manuf. Date: 2014-03-16
Retest Date: 2017-03-15
Report Date: 2014-04-09
Items
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Specifications
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Results
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Appearance
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A white or almost white,crystalline powder
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Whitecrystalline powder
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Solubility
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Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride
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Complies
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Identification
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A: IR-Spectrum
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Meets the requirement
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Complies
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B: HPLC
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Meets the requirement
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Complies
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Specific optical rotation
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Between+162°and +168°
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+165.4°
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Loss on drying
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Not more than 1.0%
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0.09%
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Related substances
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Impurity D RRT0.2
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Not more than 0.50%
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0.23%
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Impurity H RRT0.3
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Not more than 0.15%
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N.D
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Impurity I RRT0.5
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Not more than 0.50%
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0.17%
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Impurity M RRT0.7
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Not more than 0.10%
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0.09%
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Impurity G RRT0.8
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Not more than 0.40%
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0.08%
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Impurity E RRT0.86
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Not more than 0.50%
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0.09%
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Impurity A RRT0.96
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Not more than 0.20%
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0.09%
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Impurity B RRT1.1
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Not more than 0.20%
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N. D
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Impurity F RRT1.4
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Not more than 0.30%
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0.06%
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Impurity C RRT1.5
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Not more than 0.50%
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0.08%
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Impurity N RRT1.7
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Not more than 0.15%
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N.D
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Any unspecified impurity
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Not more than 0.10%
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Complies
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Sum of impurities
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Not more than 2.0%
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1.01%
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Assay
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Between 97.0% and 103.0%
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100.7%
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Residual solvents (in-house)
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Methanol
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Not morethan 500ppm
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Not detect out
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Ethanol
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Not more than 2000ppm
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Not detect out
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Methylene chloride
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Not more than 600ppm
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Not detect out
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Chloroform
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Not more than 60ppm
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Not detect out
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Particle size (In-house )
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90% not more than 15micron
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Complies
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Conclusion
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The product conforms to Ph.Eur. 8.0
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