L-Phenylalanine 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T. Baker®

Supplier: Avantor

Synonyms: (S)-(-)-PhenylalanineH-L-Phe-OHPhenylalanineH-Phe-OHL-α-Phenylalanine3-Phenyl-L-alanine3-Phenyl-L(-)-alanine

2086-07EA 0 INR
2086-07 2086-06
L-Phenylalanine 98.5-101.5% (dried basis) USP, Multi-Compendial, J.T. Baker®
L-α-Phenylalanine

  • Food GMP manufactured product

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

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Specification Test Results

Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
GMP Manufactured Product
Meets U.S.P Requirements
Meets J.P. Chemical Specifications
Preserve in well-closed containers.
Store in well-closed,light-resistant containers
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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