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L-Methionine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIALS

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Management of Change (MOC) category = R

BS01-10EA 0 INR InStock
BS01-10 BS01-D1 BS01-SA BS01-ST
L-Methionine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
L-Methionine


Formula: C₅H₁₁NO₂S
MW: 149.21 g/mol
Boiling Pt: 278
Melting Pt: 280…282 °C
 MDL Number: MFCD00063097
CAS Number: 63-68-3
Merck Index: 13,06004
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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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