Hydrocortisone 97.0-102.0% (dried basis), micronised powder USP, Multi-Compendial, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
Warning
|
Management of Change (MOC) category = R
MACR8830-05EA
141
SGD
MACR8830-05
MACR8830-08
Hydrocortisone 97.0-102.0% (dried basis), micronised powder USP, Multi-Compendial, Macron Fine Chemicals™
Hydrocortisone
Formula:
C₂₁H₃₀O₅ MW: 362,47 g/mol Boiling Pt: 567 °C (1013 hPa) Melting Pt: 202…204 °C Density: 1,4 g/cm³ (20 °C) |
MDL Number:
MFCD00011654 CAS Number: 50-23-7 EINECS: 200-020-1 |
Specification Test Results
Meets E.P. Chemical Specifications | — |
GMP Manufactured Product | — |
Meets U.S.P Requirements | — |
CAUTION: For Manufacturing, processing or repackaging | — |
Bulk Pharmaceutical Chemical | — |
USP - Assay (C₂₁H₃₀O₅) (dried basis) | 97.0 - 102.0 % |
USP - Organic Impurities | Passes Test |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Loss on Drying | ≤ 1.0 % |
USP - Residue on Ignition | ≤ 0.5 % |
USP - Specific Rotation [Å]²⁵D (+) | 150 - 156 Degree |
EP - Assay (C₂₁H₃₀O₅) | 97.0 - 103.0 % |
EP - Identification A | Passes Test |
EP - Identification B | Passes Test |
EP - Specific Optical Rotation (+) | 162 - 168 Degree |
EP - Related substances:impurity A | ≤ 0.2 % |
EP - Related substances: impurity B | ≤ 0.2 % |
EP - Related substances: impurity C | ≤ 0.5 % |
EP - Related substances: impurity D | ≤ 0.5 % |
EP - Related substances: impurity E | ≤ 0.5 % |
EP - Related substances: impurity F | ≤ 0.3 % |
EP - Related substances: impurity G | ≤ 0.4 % |
EP - Related substances: impurity H | ≤ 0.15 % |
EP - Related substances: impurity I | ≤ 0.5 % |
EP - Related substances: impurity N | ≤ 0.15 % |
EP - Related Substances: Unspecified impurities, Each | ≤ 0.10 % |
EP - Related substances: Total impurities | ≤ 2.0 % |
EP - Loss on Drying | ≤ 1.0 % |
Only Class 2 Solvents (Methanol) are likely to be present. All are below Option 1 limits. | |
Product Information (not specifications): | |
Appearance (white, crystalline powder) |
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