White or almost white, crystalline powder or colourless crystals
Appearance (JP)
White crystals or a white crystalline powder
Solubility (EP, BP)
Freely soluble in water, slightly soluble in ethanol (96%)
Solubility (JP)
It is freely soluble in water and practically insoluble in ethanol (99.5%). It dissolves in 6 mol/L hydrochloric acid.
Identification 1, FTIR (JP)
Matches with the standard pattern
Identification A, Specific rotation (EP, BP)
+9.20 to +10.60° (c = 2.75g in 12 mL of 6M HCl and dilute to 25.0 mL with water, at 20 ± 0.5°C, dried substance)
Identification 2 (JP)
Reactions for chlorides
Identification B, pH (EP, BP)
3.00 - 5.00 (c = 5% in water at 25°C)
Identification C, FTIR (EP, BP)
Matches with the standard pattern
Identification D, TLC (EP, BP)
The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principle spot in the chromatogram obtained with the reference solution
Identification E (EP, BP)
An orange colour develops
Identification F (EP, BP)
Reactions for chlorides
Appearance of solution (EP, BP)
Solution is clear and not more intensely coloured than reference solution BY6
Clarity and colour of solution (JP)
10% solution in water is clear and colourless
pH (5% in water at 25°C) (EP, BP)
3.00-5.00
pH (10% in water at 25°C) (JP)
3.50-4.50
Ammonium (Amino acid analysis) (EP, BP)
Complies
Ammonium (JP)
<= 0.02%
Sulfates (EP, BP)
<= 0.03%
Sulfates (JP)
<= 0.028%
Iron (EP, BP, JP)
<= 0.001%
Heavy metals (JP)
<= 0.001%
Specific rotation (EP, BP)
+9.20 to +10.60° (c = 2.75g in 12 mL of 6M HCl and dilute to 25.0 mL with water, at 20 ± 0.5°C, dried substance)
Specific rotation (JP)
+9.20 to +10.60° (c = 11.0% in 6M HCl, on anhydrous basis, at 25°C)
Releted substances : TLC (JP)
The spot other than the principal spot obtained from the sample solution is not more intense than the spot obtained from the standard solution
Ninhydrin-positive substances : System suitability : Resolution (EP, BP)
min. 1.5 between the peaks due to isoleucine and leucine
Ninhydrin-positive substances (Amino acid analysis - for each impurity) (EP, BP)
<= 0.20%
Ninhydrin-positive substances (Amino acid analysis - total impurity) (EP, BP)
<= 0.5%
Sulfated ash (EP, BP)
<= 0.10%
Residue on ignition (JP)
<= 0.10%
Loss on drying (EP, BP)
7.00 - 10.00% (at 145 - 150°C, 2hr)
Water (JP)
7.20-10.00%
Assay (NaOH Titration, on dry basis) (EP, BP)
98.50 - 101.00%
Assay (NT, anhydrous basis) (JP)
99.00 - 101.00%
Storage and Shelf Life
Storage
Store below 30°C away from bright light.
Shelf life
48 months.
Usage
Use before expiry date given on the product label.