
Scopolamine Butylbromide EP8
Criteria Method Unit Typical
Characters Visual White or almost white crystalline Complies
powder, freely soluble in water and
methylene chloride, sparingly soluble
in ethanol
Infrared spectrum compare EP 8th Edition 2.2.24 Compares to the spectrum of CRS Complies
Reaction for bromides EP 8th Edition 2.3.1 Positive reaction for bromides Complies
Solution is clear EP 8th Edition 2.2.1 Solution is clear Complies
Solution colourless EP 8th Edition 2.2.2 (II) Solution is colourless Complies
pH of Solution EP 8th Edition 2.2.3 pH units 6.2
Optical Rotation EP 8th Edition 2.2.7 Degrees of optical rotation Neg 19.7
Hyoscine and related substances
i. Impurity A peak EP 8th Edition 2.2.29 area < 0.1
ii. Impurities B, C, D, E, F & G peaks area < 0.2
iii. Any other impurity peak area < 0.1
iv. Total impurities peaks area < 0.4
Loss on Drying EP 8th Edition 2.2.32 % m/m 0.14
Sulphated Ash EP 8th Edition 2.4.14 % m/m 0.01
Assay - potentiometric EP 8th Edition 2.2.20 % m/m 99.2
Residual Solvents:
a. Methanol EP 8th Edition 2.4.24 mg/kg < 3000
b. Chloroform mg/kg nd