• date_rangePosted On :   Nov 03' 2014
• location_cityCity :   
• languageCountry :   South Korea
• content_pasteEnquiry No. :   B-131597

We want to get DMF(drug master file) and GMP certification about manufacturing entecavir. COA(Certificate of analysis) about entecavir monohydrate that we want is as following:-
Specifications Results
Assay: 98~102%(Dried substance) 99.8%
Heavy metal: Not more than 10 ppm Conforms
Water: 5.8%~6.5% 6.25%
Related substances
1)Individual impurity Not more than 0.1% 0.01%
2)Total impurities Not more than 0.3% 0.05%
Residual solvents
1)Tetrahydrofuran Not more than 100ppm <1ppm
2)Methylenechloride Not more than 300ppm 2ppm
3)Methanol Not more than 600ppm N.D.
4)Acetonitrile Not more than 100ppm N.D.
5)Ethylactate Not more than 300ppm N.D.
6)Total Not more than 1000ppm 2ppm
Kindly contact us as early as possible.