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 | Specifications | Results |
Appearance | A white or almost white,crystalline powder | Whitecrystalline powder |
Solubility | Practically insoluble in water, sparingly soluble in acetone and in alcohol, slightly in methylene chloride | Complies |
Identification | | |
A: IR-Spectrum | Meets the requirement | Complies |
B: HPLC | Meets the requirement | Complies |
Specific optical rotation | Between+162°and +168° | +165.4° |
Loss on drying | Not more than 1.0% | 0.09% |
Related substances | | |
Impurity D RRT0.2 | Not more than 0.50% | 0.23% |
Impurity H RRT0.3 | Not more than 0.15% | N.D |
Impurity I RRT0.5 | Not more than 0.50% | 0.17% |
Impurity M RRT0.7 | Not more than 0.10% | 0.09% |
Impurity G RRT0.8 | Not more than 0.40% | 0.08% |
Impurity E RRT0.86 | Not more than 0.50% | 0.09% |
Impurity A RRT0.96 | Not more than 0.20% | 0.09% |
Impurity B RRT1.1 | Not more than 0.20% | N. D |
Impurity F RRT1.4 | Not more than 0.30% | 0.06% |
Impurity C RRT1.5 | Not more than 0.50% | 0.08% |
Impurity N RRT1.7 | Not more than 0.15% | N.D |
Any unspecified impurity | Not more than 0.10% | Complies |
Sum of impurities | Not more than 2.0% | 1.01% |
Assay | Between 97.0% and 103.0% | 100.7% |
Residual solvents (in-house) | | |
Methanol | Not morethan 500ppm | Not detect out |
Ethanol | Not more than 2000ppm | Not detect out |
Methylene chloride | Not more than 600ppm | Not detect out |
Chloroform | Not more than 60ppm | Not detect out |
Particle size (In-house ) | 90% not more than 15micron | Complies |
Conclusion | The product conforms to Ph.Eur. 8.0 |