
Scopolamine Hydrobromide
Criteria Method Unit Typical
Characters Visual White or almost white crystalline Complies
powder or colourless crystals, freely
soluble in water and soluble in ethanol
B. Infrared spectrum compare EP 8th Edition 2.2.24 Compares with the spectrum of CRS Complies
Reaction for bromides EP 8th Edition 2.3.1 Gives positive reaction for bromides Complies
pH of Solution S EP 8th Edition 2.2.3 pH units 4.35
Optical Rotation EP 8th Edition 2.2.7 Degrees of optical rotation Neg 25.4
Water EP 8th Edition 2.5.12 % m/m 11.3
Sulphated Ash EP 8th Edition 2.4.14 % m/m 0.02
Assay - potentiometric EP 8th Edition 2.2.20 % m/m 98.9
Hyoscine and related substances
i. Impurity B peak EP 8th Edition 2.2.29 area < 0.5
ii. Impurities A, C, D peaks EP 8th Edition 2.2.29 area < 0.1
iii. Any other impurity peak EP 8th Edition 2.2.29 area < 0.1
iv. Total impurities peaks EP 8th Edition 2.2.29 area < 0.7
Residual Solvents:
Chloroform EP 8th Edition 2.4.24 mg/kg < 60