L-Phenylalanine

SKU:
TC098M
CAS Number : 63-91-2
Molecular Formula : C₉H₁₁NO₂
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Product Identifier

Product Code TC098M
Molecular weight 165.19
Molecular formula C9H11NO2
CAS No. 63-91-2

Quality Control

Appearance (USP) White crystals
Appearance (EP, BP) White or almost white, crystalline powder or shiny, white flakes
Appearance (JP) White crystals or crystalline powder
Solubility (USP) Sparingly soluble in water; very slightly soluble in methanol, in alcohol and in dilute mineral acids
Solubility (EP, BP) Sparingly soluble in water, very slightly soluble in ethanol (96%). It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides.
Solubility (JP) It is freely soluble in formic acid, sparingly soluble in water and practically insoluble in ethanol (95%). It dissolves in dilute hydrochloric acid.
Identification : FTIR (JP) Matches with the standard pattern
Identification A : FTIR (USP) Matches with the standard pattern
Identification A : Specific rotation (EP, BP) -35.50° to -33.00° (c = 2% in water at 20 ± 0.5°C, dried substance)
Identification B : FTIR (EP, BP) Matches with the standard pattern
Identification C : TLC (EP, BP) The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution
Identification D (EP, BP) A violet-red to violet-brown colour develops.
Appearance of solution (EP, BP) 5% solution in 103 g/L solution of HCl is clear and not more intensely coloured than reference solution BY6
Clarity & colour of solution (JP) 5% solution in 1 mol/L HCl is clear and colourless
pH (1% in water at 25°C) (JP) 5.30-6.30
pH (1% in water at 25°C) (USP) 5.40 -6.00
Specific rotation (USP) -34.70° to -32.70° (c = 2% in water at 25°C)
Specific rotation (EP, BP) -35.50° to -33.00° (c = 2% in water at 20 ± 0.5°C, dried substance)
Specific rotation (JP) -35.50° to -33.00° (c = 2% in water at 20°C, dried substance)
Chloride (USP) <= 0.05%
Chloride (EP, BP) <= 0.02%
Chloride (JP) <= 0.021%
Sulfates (USP) <= 0.03%
Sulfates (EP, BP) <= 0.03%
Sulfates (JP) <= 0.028%
Ammonium (JP) <= 0.02%
Ammonium : Amino acid analysis (EP, BP) Ammonium at 570 nm: not more than the area of the corresponding peak in the chromatogram obtained with reference solution C (0.02%)taking into account the peak due to ammonium in the chromatogram obtained with the blank solution
Iron (USP) <= 0.003%
Iron (EP, BP) <= 0.0010%
Heavy metals (JP) <= 0.002%
Arsenic (JP) <= 0.0002%
Loss on drying (EP, BP) <= 0.50% (at 105°C, 2hr)
Loss on drying (USP, JP) <= 0.30% (at 105°C, 3hr)
Sulfated ash (EP, BP) <= 0.10%
Residue on ignition (USP) <= 0.4%
Residue on ignition (JP) <= 0.1%
Ninhydrin-positive substances : system suitability : Resolution: Amino acid analysis (EP, BP) min. 1.5 between the peaks due to isoleucine and leucine
Ninhydrin-positive substances : for each impurity : Amino acid analysis (EP, BP) <= 0.20%
Ninhydrin-positive substances : Total impurity : Amino acid analysis (EP, BP) <= 0.50%
Related compound : system suitability : TLC (USP) The chromatogram of the system suitability solution exhibits two clearly separated spots.
Related compound : TLC (USP) Any secondary spot of the sample solution is not larger or more intense than the principal spot of the standard solution
Related compounds : Individual impurities : TLC (USP) <= 0.50%
Related compounds : Total impurity : TLC (USP) <= 2.0%
Related substancees : TLC (JP) The spot other than the principal spot from the sample solution are not more intense than the spot from the standard solution
Assay (NT, dried basis): (USP) 98.50 - 101.50%
Assay (NT, dried substance) : (BP, EP) 98.50 - 101.00%
Assay (NT, dried basis) : (JP) min. 98.50%

Storage and Shelf Life

Storage Condition Store below 30°C away from bright light.
Shelf life 48 months.
Usage Use before expiry date given on the product label.
CAS Number : 63-91-2
Molecular Formula : C₉H₁₁NO₂
More Information
Product Name L-Phenylalanine
SKU TC098M
CAS No 63-91-2
EC No. 200-568-1
Molecular formula C₉H₁₁NO₂
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