Table 2 Outcome of assay of DHA content in two batches of commercial DHA-Piperaquine tablets (Duo-cotecxin) using method A (HPLC) as described in the International Pharmacopoeia (4th edition)
Batch | Assay (90%-110%) | Status | Storage conditions | Assay (90%-110%) | Status |
|---|---|---|---|---|---|
171007 | 84.0% (Dec '08) | Fail | Room temperature (20°C) | 73.0% (Oct '09) | Fail |
611008 | 99.2% (T = 0) | Pass | 40°C and 75% RH (accelerated stability) | 88.6% (T = 1 month) | Fail |