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ROXITHROMYCIN |
| Sr.No | Sample Test | Result | Standard Value |
| 1. | DESCRIPTION | White Crystalline Powder | White Crystalline Powder. |
| 2. | IDENTIFICATION
by (a) T.L.C (b) L.R |
Passes Passes | |
| 3. | SOLUBILITY | Passes | Soluble in Acetone, Ethanol , Chloroform , Methylene Chloride , Ethyl Acetate , Methanol , Dimethyl Formamide . |
| 4. | MELTING POINT | 118oC | 115 oC to 125 oC |
| 5. | MOISTURE | 2.19% | Max 3.0 % |
| 6. | HEAVY METAL | Passes | Not > 0.0025 % (25 ppm) |
| 7. | RESIDUE ON IGNITION | 0.11 % | Max 0.2 % |
| 8. | ASSAY : [On Dry Basis] H.P.L.C
MICROBIOLOGICAL |
96.31 % 985 mcg/mg | Not < 96.0 %
Not < 960 mcg / mg |
| 9. | SPECIFIC ROTATION
[On Dry Basis] |
-78.56o -84.16o | Between -75o to -81o
(In 0.45 % w/v sol in CHCL3) Between -82o to 85o (In 0.45 % w/v sol in CH3OH) |
| 10. | RELATED SUBSTANCE | Approx 1.5 % | Max 3.0 % |
| 11. | pH | 9.80 | Between 8 to 10 |
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