JT Baker® 4203-08 Urea, USP Grade, Multi-Compendial Grade, 85Lb Poly Drum
- 85Lb Poly Drum
- Manufacturer Part No: JT-4203-08
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Assay (NH₂CONH₂) | 98.0 - 102.0 % |
USP - Residue on Ignition | <= 0.1 % |
USP - Alcohol Insoluble Matter | <= 0.04 % |
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 - Heavy Metals (as Pb) | <= 0.002 % |
USP - Endotoxin Concentration (EU/g) | <= 2.5 |
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 - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Loss on Drying at 105°C | <= 1.0 % |
EP/BP - Ash (sulfated) | <= 0.1 % |
JP - Assay (NH₂CONH₂) | 99.0 - 101.0 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Chloride (Cl) | <= 0.007 % |
JP - Sulfate (SO₄) | <= 0.010 % |
JP - Heavy Metals (as Pb) | <= 20 ppm |
JP - Alcohol Insoluble Matter | <= 0.040 % |
JP - Residue on Ignition | <= 0.10 % |
JP - Melting Point | 132.5 - 134.5 °C |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
Manufactured exclusively for Avantor Performance Materials, Inc., by BioSpectra, Inc., Stroudsburg, PA |
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Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Assay (NH₂CONH₂) | 98.0 - 102.0 % |
USP - Residue on Ignition | <= 0.1 % |
USP - Alcohol Insoluble Matter | <= 0.04 % |
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 - Heavy Metals (as Pb) | <= 0.002 % |
USP - Endotoxin Concentration (EU/g) | <= 2.5 |
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 - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Loss on Drying at 105°C | <= 1.0 % |
EP/BP - Ash (sulfated) | <= 0.1 % |
JP - Assay (NH₂CONH₂) | 99.0 - 101.0 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Chloride (Cl) | <= 0.007 % |
JP - Sulfate (SO₄) | <= 0.010 % |
JP - Heavy Metals (as Pb) | <= 20 ppm |
JP - Alcohol Insoluble Matter | <= 0.040 % |
JP - Residue on Ignition | <= 0.10 % |
JP - Melting Point | 132.5 - 134.5 °C |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
Manufactured exclusively for Avantor Performance Materials, Inc., by BioSpectra, Inc., Stroudsburg, PA |