ERYTHROMYCIN STEARATE BP 643-22-1 630.82 IU/mg
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SR.NO. |
TEST |
SPECIFICATION |
OBSERVATION |
01 |
CHARACTERS Appearance Solubility |
White crystalline powder, Practically insoluble in water, soluble in acetone, in ethanol & in methanol. Solution in this four solvent may be opalescent. |
White crystalline powder, Practically insoluble in water, soluble in acetone, in ethanol & in methanol. Solution in this four solvent may be opalescent. |
02 |
IDENTIFICATION |
To comply the test A & B |
Complies |
03 |
pH |
Between 7.0 & 10.5 |
9.68 |
04 |
ERYTHROMYCIN STEARATE |
Not less than 84.0% |
87.62%
|
05 |
FREE STEARIC ACID |
Not more than 14.0% |
10.86% |
06 |
ERYTHROMYCIN STEARATE & FREE STEARIC ACID |
Not less than 98.0% and Not more than 103% |
98.48% |
07 |
SULPHATED ASH |
Not more than 0.5% |
0.12% |
08 |
WATER |
Not more than 4.0% |
3.09% |
09 |
ASSAY |
Not less than 600 IU/mg as C36H67NO13,C18H36O2 on dry basis |
630.82 IU/mg |
Conclusion: The product complies as per BP’99 Specification.
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