| Scopolamine Butylbromide EP6 | ||||||
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| 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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