JT Baker® 4206-07 Urea, USP Grade, 12Kg Poly Pail
- 12Kg Poly Pail
- Manufacturer Part No: JT-4206-07
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
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 - Heavy Metals (as Pb) | <= 0.002 % |
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 % |
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 | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. |
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Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
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 - Heavy Metals (as Pb) | <= 0.002 % |
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 % |
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 | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. |