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Scopolamine Butylbromide EP8
Criteria Method Unit Typical
Characters Visual White or almost white crystalline powder,
freely soluble in water and methylene chloride,
sparingly soluble in ethanol
Complies
Infrared spectrum compare EP 8th Edition 2.2.24 Compares to 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
ii. Impurities B, C, D, E, F & G peaks
iii. Any other impurity peak
iv. Total impurities peaks

EP 8th Edition 2.2.29



area
area
area
area

< 0.1
< 0.2
< 0.1
< 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
b. Chloroform
EP 8th Edition 2.4.24
mg/kg
mg/kg

< 3000
nd
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