L-Methionine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIALS US
Synonyms:
(S)-(-)-2-Amino-4-(methylthio)butyric acid, (S)-(-)-Methionine, L(-)-Methionine, (S)-(-)-2-Amino-4-(methylthio)butanoic acid, H-Met-OH, Methionine, (S)-2-Amino-4-(methylthio)butanoic acid
Management of Change (MOC) category = R
BS01-10
BS01-D1
BS01-SA
BS01-ST
JTBS01-10EA
3252.78
USD
JTBS01-10
JTBS01-D1
JTBS01-SA
JTBS01-ST
L-Methionine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
L-Methionine
|
Formula:
C₅H₁₁NO₂S MW: 149.21 g/mol Melting Pt: 280…282 °C |
MDL Number:
MFCD00063097 CAS Number: 63-68-3 |
Specification Test Results
| GMP Manufactured Product | |
| Meets J.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| 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 % |
| Bacterial endotoxins, EU/g | ≤100 |
| Total Aerobic Microbial Count | ≤100 cfu/g |
| Total Yeasts and Molds | ≤100 cfu/g |
| Only Class 2 Solvents (Methanol) are likely to be present. All are | |
| below Option 1 limits. | |
| 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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