L-Phenylalanine 98.5-101.5% (dried basis) USP, Multi-Compendial, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIALS US
Synonyms:
H-L-Phe-OH, Phenylalanine, H-Phe-OH, L-α-Phenylalanine, (S)-(-)-Phenylalanine, 3-Phenyl-L-alanine, 3-Phenyl-L(-)-alanine
Management of Change (MOC) category = R
4945-06
4945-07
MK4945-06EA
1886.48
USD
MK4945-06
MK4945-07
L-Phenylalanine 98.5-101.5% (dried basis) USP, Multi-Compendial, Macron Fine Chemicals™
L-Phenylalanine
Formula:
C₉H₁₁NO₂ MW: 165.19 g/mol Boiling Pt: 313 °C (1013 hPa) Melting Pt: 173 °C Density: 0.754 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064227 CAS Number: 63-91-2 EINECS: 200-568-1 Merck Index: 14,07271 |
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 (C₉H₁₁NO₂) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) | -34.7 - -32.7 Degree |
USP - pH | 5.4 - 6.0 |
USP - Loss on Drying at 105°C | ≤ 0.3 % |
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 (C₉H₁₁NO₂) (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 (+) | -35.5 - -33.0 Degree |
EP/BP-Ninhydrin-Positive Substances-Each | ≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤ 0.5 % |
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 (C₉H₁₁NO₂) (dried basis) | 98.5 - 101.0 % |
JP - Identification | Passes Test |
JP - Optical Rotation (+) | -35.5 - -33.0 Degree |
JP - pH | 5.3 - 6.3 |
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. | |
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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