L(+)-Leucine USP, Multi-Compendial, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIALS US
Synonyms:
(S)-(+)-Leucine, Leu, H-Leu-OH, Leucine, L-Leucine
4944-06
4944-07
MK4944-06EA
1984.89
USD
MK4944-06
MK4944-07
L(+)-Leucine USP, Multi-Compendial, Macron Fine Chemicals™
L(+)-Leucine
|
Formula:
C₆H₁₃NO₂ MW: 131.17 g/mol Melting Pt: 300 °C Density: 1.165 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00002617 CAS Number: 61-90-5 EINECS: 200-522-0 Merck Index: 14,05451 |
Specification Test Results
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| 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 (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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