White to practically white crystals or crystalline powder
Appearance (EP, BP, IP)
White or almost white, crystalline powder
Appearance (JP)
White to pale yellow, crystalline powder.
Solubility (USP)
Freely soluble in water, slightly soluble in alcohol, insoluble in ether
Solubility (EP, BP)
Freely soluble in water, slightly soluble in ethanol (96%)
Solubility (JP)
Freely soluble in water, slightly soluble in ethanol (99.5%), and practically insoluble in acetic anhydride and in acetic acid (100%)
Solubility (IP)
Freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in chloroform and in ether
Melting point (JP)
~206°C, with decomposition
Melting point (EP, BP)
~205°C, with decomposition
Identification 1 (UV) : (JP)
Both spectra exhibit similar intensities of absorption at the same wavelengths
Identification A : FTIR (USP, IP)
Matches with the standard pattern
Identification A : UV (EP, BP)
Complies
Identification 2 : FTIR (JP)
Matches with the standard pattern
Identification B : Chloride (USP)
Meets the requirements
Identification B : FTIR (EP, BP)
Matches with the standard pattern
Identification B : UV (IP)
Complies
Identification 3 : Chloride (JP)
Complies
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 C : HPLC (IP)
The principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
Identification D : Chloride (EP, BP, IP)
Complies
Appearance of solution (EP, BP)
5% solution in water is clear and not more intensely coloured than reference solution Y7
Appearance of solution (IP)
5% solution in water is clear and not more intensely coloured than reference solution YS7
Clarity and color of solution (JP)
5% solution in water is clear and colorless
pH (5% in water at 25°C) : (EP, BP, IP)
2.40 - 3.00
pH (2% in water at 25°C) : (JP)
2.50 - 3.50
Heavy metals (JP, USP)
<= 0.0030%
Heavy metals (BP, IP)
<= 0.0020%
Sulfated ash (EP, BP, IP)
<= 0.10%
Residue on ignition (USP, JP)
<= 0.10%
Loss on drying (USP)
<= 0.50% (in vacuum over silica gel, 4 hr)
Loss on drying (JP)
<= 0.30% (in vacuum over silica gel, 4 hr)
Loss on drying (EP, BP, IP)
<= 0.50% (at 105°C, 2 hr)
Related 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.
Related substances (system suitability 1, HPLC) : Resolution (USP)
>= 2.5, between pyridoxine and p-hydroxybenzoic acid
Related substances (system suitability 2, HPLC) : RSD (USP)
<= 3.00%
Related substances (system suitability, HPLC) : Resolution (EP, BP)
>= 1.5, between the peaks due to impurities A and B
Related substances (system suitability, HPLC): Resolution (IP)
>= 1.5, between the peaks due to pyridoxine impurities A and B
Related substances : Impurity B, HPLC (EP, BP, IP)
<= 0.15%
Related substances : Unspecified impurities, for each impurity, HPLC (EP, BP, IP)
<= 0.10%
Related substances : Total impurities, HPLC (EP, BP, IP)