L(+)-Isoleucine USP, Multi-Compendial, Macron Fine Chemicals™

Supplier: Avantor Performance Materials

Synonyms: L-Isoleucine, (2S,3S)-(+)-Isoleucine, H-Ile-OH

MACR4943-06EA 514 SGD
MACR4943-06 MACR4943-05 MACR4943-07
L(+)-Isoleucine USP, Multi-Compendial, Macron Fine Chemicals™
L(+)-Isoleucine

L-Isoleucine, U.S.P. Multi-Compendial. GMP Manufactured Product Bulk Pharmaceutical Chemical


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 impuri profile report.


Caution: For Manufacturing, processing or repackaging

Formula: H₃CCH₂CH(CH₃)CH(NH₂)COOH
MW: 131,17 g/mol
Melting Pt: 279…280 °C
Storage Temperature: Ambient
MDL Number: MFCD00064222
CAS Number: 73-32-5
EINECS: 200-798-2
Merck Index: 14,05179

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Specification Test Results

Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets U.S.P Requirements
Meets J.P. Chemical Specifications
GMP Manufactured Product
USP - Assay (C₆H₁₃NO₂) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²⁵ ^D (+) 38.9 - 41.8 °
USP - pH 5.5 - 7.0
USP - Loss on Drying at 105°C ≤ 0.3 %
USP - Residue on Ignition ≤ 0.3 %
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 (C₆H₁₃NO₂) (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 (+) 40.0 - 43.0 °
EP/BP-Ninhydrin-Positive Substances-Impurity A ≤ 0.3 %
EP/BP-Ninhydrin-Positive Substances-Impurity C ≤ 0.3 %
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 (C₆H₁₃NO₂) (dried basis) 98.5 - 101.0 %
JP - Identification Passes Test
JP - Optical Rotation (+) 39.5 - 41.5 °
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 < 0.01

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