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Scopolamine Butylbromide EP6
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 6th Edition 2.2.24 Compares to spectrum of CRS Complies
Reaction for Bromides EP 6th Edition 2.3.1 positive reaction for bromides Complies
Solution is clear EP 6th Edition 2.2.1 Solution is clear Complies
Solution colourless EP 6th Edition 2.2.2 (II) Solution is colourless Complies
pH of Solution EP 6th Edition 2.2.3 pH units 6.2
Optical Rotation EP 6th 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 6th Edition 2.2.29



area
area
area
area

< 0.1
< 0.2
< 0.1
< 0.4
Loss on Drying EP 6th Edition 2.2.32 % m/m 0.14
Sulphated Ash EP 6th Edition 2.4.14 % m/m 0.01
Assay potentiometric EP 6th Edition 2.2.20 % m/m 99.2
Residual Solvents:
a. Methanol
b. Chloroform
EP 6th Edition 2.4.24
mg/kg
mg/kg

< 3000
nd
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