MFDS-accredited Testing List
Test Method to following The Korean pharmacopoeia and International pharmacopoeia
| Dosage form | Test title | Test method reference |
|---|---|---|
| Injections (including Biological product) |
Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Irrigant | Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Ophthalmic solutions | Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Liquid | Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Powder | Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Freeze-dried powder injection | Appearance | Guidelines for labeling pharmaceutical products appearance USP_General Notices and Requirements |
| Injections (including Biological product) |
pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Perfusafe | pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Ophthalmic solutions | pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Liquid | pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Powder | pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Freeze-dried powder injection | pH | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injections (including Biological product) |
Determination of Volume of Injection in Containers | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Perfusafe | Determination of Volume of Injection in Containers | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Ophthalmic solutions | Insoluble Particulate Matter Test for Ophthalmic Solutions | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injection | Particulate Matter of Injection | The Korean pharmacopoeia |
| Liquid | Mass variation | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Ophthalmic solutions | Mass variation | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injections (including Biological product) |
Total protein quantification | The Korean pharmacopoeia |
| Liquid | Microbial Limit Test (Microbial enumeration tests-Spreader method) |
The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injections (including Biological product) |
Endotoxin (colorimetry) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Irrigant | Endotoxin (colorimetry) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injections (including Biological product) |
Sterility test (Membrane filter method) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Irrigant | Sterility test (Membrane filter method) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Ophthalmic solutions | Sterility test (Membrane filter method) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Freeze-dried powder injection | Sterility test (Membrane filter method) | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Injections (including Biological product) |
Foreign insoluble matter test | The Korean pharmacopoeia United States Pharmacopeia European Pharmacopoeia |
| Irrigant | 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"
| Dosage form | Test title | Test method reference |
|---|---|---|
| Injections (including Biological product) |
Thermal analysis | Biological product Specification and test method_general test method |
| Injections (including Biological product) |
Mycoplasma test-direct culture method, indirect indicator cell culture method | Biological product Specification and test method_general test method |