JT Baker® 6253-06 L-Alanine, USP Grade, Multi-Compendial Grade, 1Kg Glass Bottle
Item is discontinued. The manufacturer’s recommended alternate is item# 95033-824.
Item Number:JTB-6253-06
Manufacturer Part No:JT-6253-06
Manufacturer:Avantor
Units:4 x 1Kg Glass Bottles/Case (Or Sold Individually)
Details
- 4 x 1Kg Glass Bottles/Case (Or Sold Individually)
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification | Passes Test |
| USP - Assay (dried basis) | 98.5 - 101.5 % |
| USP - Residue on Ignition | <= 0.15 % |
| USP - Chloride (Cl) | <= 0.05 % |
| USP - Sulfate (SO₄) | <= 0.03 % |
| USP - Iron (Fe) | <= 30 ppm |
| USP - Heavy Metals (as Pb) | <= 15 ppm |
| USP - Related Compounds - Individual Impurities | <= 0.5 % |
| USP - Related Compounds - Total Impurities | <= 2.0 % |
| USP - Specific Rotation [Å]²⁵ ^D (+) | 13.7 - 15.1 Degree |
| USP - pH | 5.5 - 7.0 |
| USP - Loss on Drying | <= 0.2 % |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Appearance of Solution | Passes Test |
| EP - Specific optical rotation (+) | 13.5 - 15.5 Degree |
| EP/BP - Ninhydrin Positive Substances - Each Impurity | <= 0.10 |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | <= 0.5 % |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 300 ppm |
| EP/BP - Ammonium (NH₄) | <= 0.02 % |
| EP - Iron (Fe) | <= 10 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Loss on Drying at 105°C | <= 0.5 % |
| EP - Sulfated Ash | <= 0.1 % |
| EP - Assay (dried basis) | 98.5 - 101.0 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| 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 E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification | Passes Test |
| USP - Assay (dried basis) | 98.5 - 101.5 % |
| USP - Residue on Ignition | <= 0.15 % |
| USP - Chloride (Cl) | <= 0.05 % |
| USP - Sulfate (SO₄) | <= 0.03 % |
| USP - Iron (Fe) | <= 30 ppm |
| USP - Heavy Metals (as Pb) | <= 15 ppm |
| USP - Related Compounds - Individual Impurities | <= 0.5 % |
| USP - Related Compounds - Total Impurities | <= 2.0 % |
| USP - Specific Rotation [Å]²⁵ ^D (+) | 13.7 - 15.1 Degree |
| USP - pH | 5.5 - 7.0 |
| USP - Loss on Drying | <= 0.2 % |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Appearance of Solution | Passes Test |
| EP - Specific optical rotation (+) | 13.5 - 15.5 Degree |
| EP/BP - Ninhydrin Positive Substances - Each Impurity | <= 0.10 |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | <= 0.5 % |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 300 ppm |
| EP/BP - Ammonium (NH₄) | <= 0.02 % |
| EP - Iron (Fe) | <= 10 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Loss on Drying at 105°C | <= 0.5 % |
| EP - Sulfated Ash | <= 0.1 % |
| EP - Assay (dried basis) | 98.5 - 101.0 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| 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. | |