Injections (including Biological product)
Test Method to following The Korean pharmacopoeia and International pharmacopoeia
| Test title | Test method reference |
|---|---|
| Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Determination of Volume of Injection in Containers | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Particulate Matter of Injection | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Total protein quantification | The Korean pharmacopoeia |
| Endotoxin (colorimetry) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Sterility test (Membrane filter method) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Foreign insoluble matter test | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
Test Method to following others such as "Biological product Specification and test method"
| Test title | Test method reference |
|---|---|
| Thermal analysis | Biological product Specification and test method_general test method |
| Mycoplasma test-direct culture method, indirect indicator cell culture method | Biological product Specification and test method_general test method |