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 |
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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