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25 Kilogram |
Negotiable |
Ganciclovir GANCYCLOVIR Ganciclovir gmp
USP
Description |
White crystalline odorless powder |
Identification |
1.IR vs standard:The IR absorption spectrum of the preparation of the test specimen exhibits maxima only at the same wavelengths as that of a similar preparation of the standard . 2.UV vs standard:The UV absorption spectra of the test solution and the standard solution exhibit maxima and minima at the same wavelengths. |
Solubility |
Very slightly soluble in water very soluble in dilute alkaline solutions |
Assay |
Not less than 98.0% and not more than 102.0% on dried basis |
Related substances |
Nomorethan0.5%ganciclovir related compound A No more than 1.5% for total impurities |
Organic remain |
Nomorethan0.3%carbinol Nomorethan0.088%DMF Nomorethan0.006%chloroform |
Water |
No more than 6.0% |
Heavy metals |
Not more than 0.002% |
Residue on ignition |
Not more than 0.1% |
Bacterial endotoxins |
0.3EUndotoxin Unit per mg |
Absorption index |
E1%1cm516~548 |
Microorganism |
Total bacterial count: max 100UFC/gram Fungus and /orYeast :max 10UFC/gram Pathogens search: E.coli: absent P.aerugmosa: absent S.aureus :absent Salmonella:absent |
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