Hydrocortison 97.0-102.0% (dried basis), micronized powder USP, Multi-Compendial, Macron Fine Chemicals™
Leverandør: Avantor Performance Materials
Ratings:
Ingen bedømmelse
Samlet vurdering
Gennemsntilig vurdering
Advarsel
|
Management of Change (MOC) category = R
8830-05EA
10400
DKK
8830-05
8830-08
Hydrocortison 97.0-102.0% (dried basis), micronized powder USP, Multi-Compendial, Macron Fine Chemicals™
Hydrocortison
Formel:
C₂₁H₃₀O₅ Molekylvægt: 362,47 g/mol Kogepunkt: 567 °C (1013 hPa) Smeltepunkt: 202…204 °C Massefylde: 1,4 g/cm³ (20 °C) |
MDL Number:
MFCD00011654 CAS-nummer: 50-23-7 EINECS: 200-020-1 |
Specifikationer Testresultater
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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