L(+)-Leucine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
L-Leucine
, (S)-(+)-Leucine
, Leucine
, Leu
, H-Leu-OH
Management of Change (MOC) category = R
BAKRBS02-10
BAKRBS02-SA
BAKRBS02-10
JTBS02-SACS
182.54
USD
CAJTBS02-10
JTBS02-SA
JTBS02-10
L(+)-Leucine 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
L(+)-Leucine
|
Formula:
C₆H₁₃NO₂ MW: 131.17 g/mol |
MDL Number:
MFCD00002617 CAS Number: 61-90-5 |
Specification Test Results
| Meets J.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₆H₁₃NO₂) (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Specific Rotation [Å]²⁵ ^D (+) | 14.9 - 17.3 Degree |
| USP - pH | 5.5 - 7.0 |
| USP - Loss on Drying at 105°C | ≤0.2 % |
| USP - Residue on Ignition | ≤0.4 % |
| 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 (+) | 14.5 - 16.5 Degree |
| EP/BP-Ninhydrin-Positive Substances-Impurity A | ≤0.8 % |
| 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 at 105°C | ≤0.5 % |
| EP/BP - Ash (sulfated) | ≤0.1 % |
| JP - Assay (C₆H₁₃NO₂) (dried basis) | 98.5 - 101.0 % |
| JP - Identification | Passes Test |
| JP - Optical Rotation (+) | 14.5 - 16.0 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 after 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. | |
| 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 impurity profile report. |
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