L(+)-Valine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™

Supplier: Avantor Performance Materials

Synonyms: (S)-(+)-ValineValineH-Val-OH

4936-09EA 0 EUR
4936-09 4936-06 MACR4936-07
L(+)-Valine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Valine
Formula: C₅H₁₁NO₂
MW: 117,15 g/mol
MDL Number: MFCD00064220
CAS Number: 72-18-4

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Specification Test Results

Meets B.P. Chemical Specifications
GMP Manufactured Product
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 (C₅H₁₁NO₂) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²⁵ ^D (+) 26.6 - 28.8 Degree
USP - pH 5.5 - 7.0
USP - Loss on Drying at 105°C ≤0.3 %
USP - Residue on Ignition ≤0.1 %
USP - Chloride (Cl) ≤0.05 %
USP - Sulfate (SO₄) ≤0.03 %
USP - Iron (Fe) ≤0.003 %
USP - Related Compounds - Individual Impurities ≤0.5 %
USP - Related Compounds - Total Impurities ≤2.0 %
EP/BP - Assay (C₅H₁₁NO₂) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Specific Rotation [Å]²º^D (+) 26.5 - 29.0 Degree
EP/BP-Ninhydrin-Positive Substances-Impurity B ≤0.4 %
EP/BP-Ninhydrin-Positive Substances-Each ≤0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤1.0 %
EP/BP - Chloride (Cl) ≤200 ppm
EP/BP - Sulfate (SO₄) ≤300 ppm
EP/BP - Ammonium (NH₄) ≤0.02 %
EP/BP - Iron (Fe) ≤10 ppm
EP/BP - Loss on Drying ≤0.5 %
EP/BP - Ash (sulfated) ≤0.1 %
JP - Assay (C₅H₁₁NO₂) (dried basis) 98.5 - 101.0 %
JP - Identification Passes Test
JP - Optical Rotation (+) 26.5 - 29.0 Degree
JP - pH 5.5 - 6.5
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 on Ignition ≤0.10 %
Endotoxin Concentration, IU/mg, For Information Only
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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