Hydrocortisone CAS: 50-23-7 High quality Hydrocortisone EP/USP Hydrocortisone
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Items |
Specifications |
Results |
Appearance |
A white or almost white, crystalline powder |
White crystalline 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 more than 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 |
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