Other quality inspection tests
Test list
| No. | Category | Test | Test method andspecification |
|---|---|---|---|
| 1 | General test | pH | KP_12, 76 |
| 2 | Insoluble Particulate Matter Test | KP_12, 20 | |
| 3 | Mass variation | KP_12, 61 | |
| 4 | Appearance | NationalInstitute of Food and Drug Safety Evaluation Guidelines of labelling pharmaceutical products appearance |
|
| 5 | Loss on ignition | KP_12, 02 | |
| 6 | Residue onignition | KP_12, 03 | |
| 7 | Loss on drying | KP_12, 04 | |
| 8 | Polyacrylamidegel electrophoresis | KP_12, 74 | |
| 9 | Total protein quantification | KP_12, 70 | |
| 10 | Thermal analysis | Biologic_testmethod and specification_general test method_Article 2-6 | |
| 11 | HPLC analysis (Identification / Assay / Purity test) |
KP_12, 39 | |
| 12 | GC analysis (Identification / Assay / Purity test) | KP_12, 10 | |
| 13 | FT-IR analysis (Identification / Purity test) | KP_12, 54 | |
| 14 | UV/vis analysis (Identification / Assay / Purity test) | KP_12, 52 | |
| 15 | Water content (Coulometry) | KP_12, 33 | |
| 16 | Osmometry | KP_12, 29 | |
| 17 | Particle size analysis | ISO 22412 | |
| 18 | Zeta potential analysis | ISO 22412 | |
| 19 | Microbiologicaltest | Sterility test (Membrane filter method) | KP_12, 12 |
| 20 | Microbial LimitTest (Microbialenumeration tests-Spreader method) | KP_12, 13 | |
| 21 | Endotoxin (Colorimetry / Gel-clot) | KP_12, 40 |
1) Applicable sample: Liquid, solid (powder)
2) In case of microbial test, MV (method validation) included
3) In case of HPLC quantification, MV (method validation) included with the report
4) Able to issue the report for self-testing (for reference, not submission to regulatory)