API TESTING SPECIFICATION |
Name: Erythromycin Estolate BP. |
T.S.No.: SPEC/API/HEE-006/B/01
Issue Date: 01/03/2006 |
Code: HEE |
CAS: 3521-62-8 |
Storage: Protected from light. |
Supersede: SPEC/API/HEE-006/B
Date: 01/04/2002 |
M.F.: C40 H71 NO14, C12 H26 O4 S |
M.W.:1056.00g/mole |
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Test |
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Specification |
Description |
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White or almost white, crystalline powder. |
Solubility |
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Practically insoluble in water, freely soluble in ethanol (96 percent), soluble in acetone. It should practically insoluble in dilute hydrochloric acid. |
Identification |
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The Infra-red absorption spectrum should be concordant with the reference spectrum of erythromycin Estolate CRS. |
Related substances |
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Impurities A, B, C, D, E, F, G: NMT 3.00% (For each impurity)
Any other impurity : NMT 0.20 %
Total impurities : NMT 5.00 % |
Free erythromycin |
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Not more than 6.00%. |
Dodecyl Sulphate |
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23.00% to 25.50% of C12H26O4S (anhydrous substance). |
Water |
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Maximum 4.00%. |
Sulphated Ash |
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Maximum 0.500%. |
Assay |
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86.00% to 102.00% (anhydrous substance).
Erythromycin-B: Maximum 5.00%
Erythromycin-C: Maximum 5.00% |
End of specification |
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