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CAS NO.50-23-7
Good quality
Competitive price
On time delivery
Hydrocortisone
1. CAS No.: 50-23-7
2. Quality: EP6/USP32
3. Document: COS, DMF, GMP
4. Specification of Hydrocortisone with GMP, DMF, COS. with competitive price.
EP6/USP32
| ITEMS | SPECIFICATION EP6/USP32 | RESULTS |
| CHARACTERS(PH.EUR.) | A WHITE OR ALMOST WHITE,CRYSTALLINE POWDER | WHITE CRYSTALLINE POWDER |
| SOLUBILITY(PH.EUR.) | PRACTICALLY INSOLUBLE IN WATER,SPARINGLY SOLUBLE IN ACETONE AND IN ALCOHOL,SLIGHTLY IN METHYLENE CHLORIDE | COMPLIES |
| IDENTIFICATION | ||
| A.IR-SPECTRUM(PH.EUR) | MEETS THE REQUIREMENT | COMPLIES |
| B.TLC(PH.EUR) | MEETS THE REQUIREMENT | COMPLIES |
| A.IR-SPECTRUM(USP) | MEETS THE REQUIREMENT | COMPLIES |
| B.UV ABSORPTION(USP) | MEETS THE REQUIREMENT | COMPLIES |
| SPECIFIC OPTICAL ROTATION | ||
| (PH.EUR) | BETWEEN+150°AND +156° | +152.1° |
| (USP) | BETWEEN+150°AND +156° | +153.3° |
| LOSS ON DRYING | ||
| (PH.EUR) | NOT MORE THAN 1.0% | 0.04% |
| (USP) | NOT MORE THAN 1.0% | 0.05% |
| RESIDUE ON IGNITION(USP) | NEGLIGIBLE,FROM 100MG | COMPLIES |
| RELATED SUBSTANCES(PH.EUR) | ||
| ANY INDIVIDUAL IMPURITY | NOT MORE THAN 0.5% | 0.30% |
| SUM OF IMPURITIES | NOT MORE THAN 1.5% | 1.24% |
| CHROMATOGRAPHIC PURITY(USP) | ||
| ANY INDIVIDUAL IMPURITY | NOT MORE THAN 0.5% | 0.28% |
| SUM OF IMPURITIES | NOT MORE THAN 2.0% | 1.25% |
| ASSAY | ||
| UV ABSORPTION(PH.EUR.) | BETWEEN 97.0% AND 103.0% | 100.70% |
| HPLC(USP) | BETWEEN 97.0% AND 102.0% | 98.70% |
| RESIDUAL SOLVENT(IN-HOUSE) | ||
| METHANOL | NOT MORE THAN 500PPM | NOT DETECT OUT |
| ETHANOL | NOT MORE THAN 2000PPM | 455PPM |
| METHYLENE CHLORIDE | NOT MORE THAN 600PPM | NOT DETECT OUT |
| ITEMS | SPECIFICATION | RESULTS |
| CHLOROFORM | NOT MORE THAN 60PPM | NOT DETECT OUT |
| PARTICLE SIZE(IN-HOUSE) | 90% NOT MORE THAN 15 MICRONS | COMPLIES |
|
CONCLUSION:THE PRODUCT CONFORMS TO PH.EUR.6/USP34 |
||