Urea 98.0-102.0%, GenAR® USP, Macron Fine Chemicals™

Synonyms: Carbonyl diamideCarbamideCarbonyldiamideDiaminomethanone

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
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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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