L-Methionine 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
2085-06EA
858.24
EUR
2085-06
2085-07
2085-05
L-Methionine 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T.Baker®
L-Methionine
- Food GMP manufactured product
Specification Test Results
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 - Assay (C₅H₁₁NO₂S) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | 22.4 - 24.7 Degree |
USP - pH | 5.6 - 6.1 |
USP - Loss on Drying at 105°C | ≤0.3 % |
USP - Residue on Ignition | ≤0.4 % |
USP - Chloride (Cl) | ≤0.05 % |
USP - Sulfate (SO₄) | ≤0.03 % |
USP - Iron (Fe) | ≤0.003 % |
USP - Related Compounds - Methionine sulfoxide | ≤0.1 % |
USP - Related Compounds - N-Acetyl-D,L- methionine | ≤0.2 % |
USP - Related Compounds - Any unspecified impurity | ≤0.1 % |
USP - Related Compounds - Total unspecified impurities | ≤0.30 % |
EP/BP - Assay (C₅H₁₁NO₂S) (dried basis) | 99.0 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH | 5.5 - 6.5 |
EP/BP - Specific Rotation [Å]²º^D (+) | 22.5 - 24.0 Degree |
EP/BP - Related Substances: Unspecified Impurities, each | ≤0.10 % |
EP/BP - Related Substances: Total Impurities | ≤0.3 % |
EP/BP - Chloride (Cl) | ≤200 ppm |
EP/BP - Sulfate (SO₄) | ≤300 ppm |
EP/BP - Ammonium (NH₄) | ≤200 ppm |
EP/BP - Iron (Fe) | ≤10 ppm |
EP/BP - Loss on Drying at 105°C | ≤0.5 % |
EP/BP - Ash (sulfated) | ≤0.1 % |
JP - Assay (C₅H₁₁NO₂S) (dried basis) | 98.5 - 101.0 % |
JP - Identification | Passes Test |
JP - Optical Rotation (+) | 21.0 - 25.0 Degree |
JP - pH | 5.2 - 6.2 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) | ≤0.021 % |
JP - Sulfate (SO₄) | ≤0.028 % |
JP - Ammonium (NH₄) | ≤0.02 % |
JP - Heavy Metals (as Pb) | ≤20 ppm |
JP - Arsenic (As) | ≤2 ppm |
JP - Related Substances | Passes Test |
JP - Loss on Drying at 105°C | ≤0.30 % |
JP - Residue after Ignition | ≤0.10 % |
Endotoxin Concentration, IU/mg, For Information Only | |
Metallic Impurities - Cobalt (Co), For Information Only | |
Only Class 2 Solvents (Methanol) are likely to be present. All are | |
below Option 1 limits. | |
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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