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Scopolamine Hydrobromide
Criteria Method Unit Typical
Characters Visual White or almost white crystalline powder
or colourless crystals, freely soluble in water,
soluble in ethanol
Complies
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 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
Impurity B peak EP 8th Edition 2.2.9 area <0.5
Impurity A, C, D peaks EP 8th Edition 2.2.9 area <0.1
Any other Impurity peaks EP 8th Edition 2.2.9 area <0.1
Total impurity peaks EP 8th Edition 2.2.9 area <0.7

Residual Solvents
Chloroform EP 8th Edition 2.4.24 mg/kg <60
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