Specification: BP/USP
| Product Name | Amoxicillin/ potassium clavulanate 4:1 |
| Quality Standard | Internal standard |
| Testing Items | Critrion |
| Characteristics | White or off white powder |
| Identification | Same retention time with standard reference |
| Melting Point | 258℃ |
| PH | 4.8-8.6 |
| Water | ≤11.0% |
| Assay Amoxicillin | ≥71.0% |
| Assay Glavulanate | ≥17.0% |
| Relative substance individual | ≤2.0% |
| Relative substance total | ≤5.0% |
| Weight ratio between two substances | 3.6-4.4 |
| Glavulanate potassium part analysis USP Standard | |
| Identification | a) Positive by HPLC b) Reaction of potassium |
| Water(KF.) | ≤1.5% |
| PH | 5.5-8.0 |
| Related substance(HPLC) | ≤2.0% |
| Clavam-2-carboxylate potassium | ≤0.01% |
| Methanol (GC) | ≤0.1% |
| Tert-Butylamine GC | ≤0.2% |
| ASSAY CLAV.(a.b) | 75.5-92.0% |