Proline BP

Appearance (Colour)

White or almost white, colourless

Appearance (Form)

Crystalline powder or crystals

Solubility

Very soluble in water,freely soluble in ethanol (96%)

Identification

A) By specific optical rotation
C) By TLC

Identification (IR Spectrum)

B) Passes

Appearance of Solution

2.5g in 50ml water is clear and colourless

Specific rotation [α]

-86.0° to -84.0° (dried substance) ( C=4, water)

Ninhydrin – Positive substance

Individual impurity : Max 0.2%
Total impurities: Max 0.5%

Chloride (CI)

Max. 200ppm

Sulphate (SO4)

Max. 300ppm

Ammonium (NH4)

NMT area of corresponding peak obtained from reference solution (c) (0.02%)

Iron (Fe)

Max. 10ppm

Loss on drying

Max. 0.5%

Sulphated Ash

Max. 0.1%

Assay (On dry basis)

98.5 – 101.0%

Reference

BP 2020