Urea 98.0-102.0%, GenAR® USP, Macron Fine Chemicals™
Synonyms:
Carbonyl diamide
, Carbamide
, Carbonyldiamide
, Diaminomethanone
Management of Change (MOC) category = R
MACR7816-06
CAMK781606
Urea 98.0-102.0%, GenAR® USP, Macron Fine Chemicals™
Urea
Formula:
NH₂CONH₂ MW: 60.06 g/mol Boiling Pt: 197 °C (1013 hPa) Melting Pt: 132.7 °C Density: 1.34 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00008022 CAS Number: 57-13-6 EINECS: 200-315-5 REACH: 01-2119463277-33 Merck Index: 12,10005 |
Specification Test Results
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Preserve in tight containers. Store at 25°C, excursions permitted 15-30°C. | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (NH₂CONH₂) | 98.0 - 102.0 % |
USP - Appearance (colorless to white prismatic crystals, or white crystalline powder, or small white pellets) | Passes Test |
USP - Alcohol Insoluble Matter | ≤ 0.04 % |
USP - Endotoxin Concentration (EU/g) | ≤ 5.0 |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Organic impurities: Urea related compound A | ≤ 0.1 % |
USP - Organic impurities: Any individual unspecified impurity | ≤ 0.1 % |
USP - Organic impurities: Total impurities | ≤ 2.0 % |
USP - Residue on Ignition | ≤ 0.1 % |
Enzyme Activity - DNase Activity | Passes Test |
Enzyme Activity - RNase Activity | Passes Test |
Enzyme Activity - Protease Activity | Passes Test |
EP/BP - Assay (NH₂CONH₂) (dried basis) | 98.5 - 101.5 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Alkalinity | Passes Test |
EP/BP - Biuret | ≤ 0.1 % |
EP/BP - Ammonium (NH₄) | ≤ 500 ppm |
EP/BP - Loss on Drying | ≤ 1.0 % |
EP/BP - Ash (sulfated) | ≤ 0.1 % |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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