JT Baker® 6254-07 L-Aspartic Acid, USP Grade, Multi-Compendial Grade, 12Kg Poly Pail
Item is discontinued with no replacement from the manufacturer. Please contact customer service for a potential alternate.
Item Number:JTB-6254-07
Manufacturer Part No:JT-6254-07
Manufacturer:Avantor
Units:12Kg Poly Pail
Details
- 12Kg Poly Pail
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Residue on Ignition | <= 0.1 % |
| USP - Chloride (Cl) | <= 0.02 % |
| USP - Sulfate (SO₄) | <= 0.03 % |
| USP - Iron (Fe) | <= 10 ppm |
| USP - Heavy Metals (as Pb) | <= 10 ppm |
| USP - Related Compounds: Maleic Acid | <= 0.05 % |
| USP - Related Compounds: Malic Acid | <= 0.20 % |
| USP - Related Compounds: Fumaric Acid | <= 0.10 % |
| USP - Related Compounds: Any unspecified impurity | <= 0.05 % |
| USP - Related Compounds: Total unspecified impurities | <= 0.10 % |
| USP - Specific Rotation [Å]²º^D | 24.0 - 26.0 Degree |
| USP - Loss on Drying | <= 0.5 % |
| EP - Assay (C₄H₇NO₄) (dried basis) | 98.5 - 101.5 % |
| EP - Identification A | Passes Test |
| EP - Identification C | Passes Test |
| EP - Appearance of Solution | Passes Test |
| EP - Specific optical rotation (+) | 24.0 - 26.0 Degree |
| EP - Ninhydrin-Positive Substances | <= 0.5 % |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 300 ppm |
| EP - Ammonium (NH₄) | <= 200 ppm |
| 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 % |
| 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 B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Residue on Ignition | <= 0.1 % |
| USP - Chloride (Cl) | <= 0.02 % |
| USP - Sulfate (SO₄) | <= 0.03 % |
| USP - Iron (Fe) | <= 10 ppm |
| USP - Heavy Metals (as Pb) | <= 10 ppm |
| USP - Related Compounds: Maleic Acid | <= 0.05 % |
| USP - Related Compounds: Malic Acid | <= 0.20 % |
| USP - Related Compounds: Fumaric Acid | <= 0.10 % |
| USP - Related Compounds: Any unspecified impurity | <= 0.05 % |
| USP - Related Compounds: Total unspecified impurities | <= 0.10 % |
| USP - Specific Rotation [Å]²º^D | 24.0 - 26.0 Degree |
| USP - Loss on Drying | <= 0.5 % |
| EP - Assay (C₄H₇NO₄) (dried basis) | 98.5 - 101.5 % |
| EP - Identification A | Passes Test |
| EP - Identification C | Passes Test |
| EP - Appearance of Solution | Passes Test |
| EP - Specific optical rotation (+) | 24.0 - 26.0 Degree |
| EP - Ninhydrin-Positive Substances | <= 0.5 % |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 300 ppm |
| EP - Ammonium (NH₄) | <= 200 ppm |
| 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 % |
| 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. | |