CERTIFICATE OF ANALYSIS
NYSTATIN
BATCH NO: NT/C 645106
MANUFACTURING DATE: MAR 2006
EXPIRY DATE: FEB 2009
| TESTS | SPECIFICATIONS | RESULTS |
| 1. Description: |
Hygroscopic light hazel powder with characteristic obour. |
Corresponding |
| 2. Solubility: |
Very slightly soluble in water, slightly soluble in e-methanol, n-propyl alcohol, n-butyl alcohol. Insoluble in chloroform, ether. |
Corresponding |
| 3. Identification: |
U.V. Spectroscopy A 230nm/A 279nm : 0,90-1,25 A 291nm/A 305nm: 0,61-0,73 A 319nm/A 305nm: 0,83-0,96 |
1,03 0,66 0,92 |
|
4. Patency: Patency(on dried substance) |
Not less than 4400 U/mg |
6000 U/mg 6270 U/mg |
| 5. Loss on drying: | Not more than 5,0% | 4,30% |
| 6. Sulphated ash: | Not more than 3,5% | 0,40% |
| 7. Absorbance at 305 nm: | Not less than 0,60 | 0,85 |
| 8. Heavy metals: | Not more than 20 p p m | Corresponding |
| 9. pH (C=3,0%): | Between 6,0 and 8,0 | 7,8 |
| 10. Crystallinity: | It reveals birefringence | Corresponding |
| 11. Particle size: | Not less than 98,0% < 80 microns Not less than 70,0% < 30 microns |
100,00% 99,90% |
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