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

: MACRON AVANTOR BRAND

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

: MACRON AVANTOR BRAND

:50-23-7

:

:C₂₁H₃₀O₅

:MFCD00011654

:567

:202…204 °C

:1.4 g/cm³ (20 °C)

:362.47

:Management of Change (MOC) category = R

:200-020-1

Environmentally Preferable:

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 %

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