Hydrocortisone 97.0-102.0% (dried basis), micronized powder USP, Multi-compendial, Macron Fine Chemicals™

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C8830-08EA 0 INR
C8830-08 C8830-05
Hydrocortisone 97.0-102.0% (dried basis), micronized 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

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Specification Test Results

GMP Manufactured Product
Meets E.P. Chemical Specifications
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 Rotationα²⁵D (+) 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: 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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