Table 1. Lopinavir (200 mg)/Ritonavir (50 mg) drug sources and characteristics.
Site | Lot No. | Manufacturer | Country | Trade name | WHO Prequal. | Expiry date | Identification | % of label amount | Uniformity of mass, % | Dissolution, % (LPV/RTV) | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Min | Max | Min | Max | |||||||||
001 | W570041 | GPO | THA | Lopinavir/Ritonavir | NO | 21 Jan 16 | Positive | 102.1/100.8 | -1.20 | 1.64 | 97.6/98.8 | 98.2/99.7 |
002 | W560404 | GPO | THA | Lopinavir/Ritonavir | NO | 13 Jul 15 | Positive | 103.2/102.4 | -1.28 | 1.48 | 98.1/100.8 | 99.1/102.2 |
003 | W570169 | GPO | THA | Lopinavir/Ritonavir | NO | 17 Mar 16 | Positive | 102.1/103.6 | -1.11 | 1.25 | 99.1/100.0 | 101.2/103.1 |
004 | W570175 | GPO | THA | Lopinavir/Ritonavir | NO | 17 Mar 16 | Positive | 101.0/103.3 | -2.22 | 2.08 | 97.7/99.0 | 101.9/102.5 |
005 | W570450 | GPO | THA | Lopinavir/Ritonavir | NO | 17 Jul 16 | Positive | 99.4/101.8 | -2.16 | 1.07 | 97.5/99.0 | 101.3/102.8 |
006 | W560432 | GPO | THA | Lopinavir/Ritonavir | NO | 23 Jul 15 | Positive | 99.0/103.0 | -2.10 | 1.87 | 98.5/100.3 | 102.6/104.6 |
007 | W570457 | GPO | THA | Lopinavir/Ritonavir | NO | 20 Jul 16 | Positive | 98.6/101.5 | -1.74 | 2.05 | 98.7/95.0 | 99.8/97.0 |
008 | W570152 | GPO | THA | Lopinavir/Ritonavir | NO | 10 Mar 16 | Positive | 99.4/101.4 | -2.09 | 1.76 | 96.2/99.0 | 98.7/102.8 |
009 | W570285 | GPO | THA | Lopinavir/Ritonavir | NO | 15 May 16 | Positive | 98.4/101.0 | -2.53 | 1.94 | 96.8/99.9 | 99.8/102.7 |
010 | W560556 | GPO | THA | Lopinavir/Ritonavir | NO | 22 Oct 15 | Positive | 97.8/101.5 | -1.47 | 1.70 | 99.1/101.4 | 101.7/103.7 |
011 | W570169 | GPO | THA | Lopinavir/Ritonavir | NO | 17 Mar 16 | Positive | 98.2/101.2 | -1.33 | 1.52 | 94.9/100.0 | 97.6/102.8 |
012 | 8000458 | Mylan | IND | Lopinavir/Ritonavir | YES | 30 Jun 16 | Positive | 99.7/101.4 | -1.69 | 1.31 | 93.4/96.3 | 98.6/102.9 |
Abbreviations: Lopinavir,LPV; Ritonavir, RTV; the Government Pharmaceutical Organization, GPO; Thailand, THA; India, IND.