Table 3.
Implementation status of the ICH Q4B in the Chinese Pharmacopoeia 2020 edition.
| ICH No./Chinese Pharmacopoeia No. | Testing method | Implementation status | Main differences | Refs. |
|---|---|---|---|---|
| Annex 1/0841 | Residue on ignition/sulfated ash | In the process of implementation | Sulfuric acid addition amount, ignition temperature, and conditions for the end of the experiment | [[64], [65], [66]] |
| Annex 2/0102, 0942 | Test for extractable volume of parenteral preparations | In the process of implementation | Sampling method, method details, and result interpretation | [[64], [65], [66]] |
| Annex 3/0903 | Test for particulate contamination: subvisible particles | In the process of implementation | Instrument calibration for the light obscuration particle count test, requirements for testing environmental water samples, sampling method, and the evaluation of injections with a labeled volume of 100 mL | [[64], [65], [66]] |
| Annex 4A/1105 | Microbiological examination of nonsterile products: microbial enumeration tests | In the process of implementation | Strains, medium, and method details | [64,66] |
| Annex 4B/1106 | Microbiological examination of nonsterile products: test for specified microorganisms | In the process of implementation | Strains, medium, method details, and result interpretation | [64,66] |
| Annex 4C/1107 | Microbiological examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use | In the process of implementation | Scope, Salmonella tests, and microbial acceptance criteria for small and microdose preparations such as patches, and standards for traditional Chinese medicines (vegetable medicines) | [64,66] |
| Annex 5/0921 | Disintegration test | In the process of implementation | Apparatus, result interpretation | [[64], [65], [66]] |
| Annex 6/0941 | Uniformity of dosage units | In the process of implementation | Methods, result interpretation | [[64], [65], [66]] |
| Annex 7/0931 | Dissolution test | In the process of implementation | Methods, result interpretation | [[64], [65], [66]] |
| Annex 8/1101 | Sterility test | In the process of implementation | Strains, number of products to be tested, filter times, and quantity of the rinsing fluid | [64,66] |
| Annex 9/0923 | Tablet friability | In the process of implementation | Apparatus, notes | [[64], [65], [66], [67]] |
| Annex 10/0541 | Polyacrylamide gel electrophoresis | In the process of implementation | Method details | [[64], [65], [66]] |
| Annex 11/0542 | Capillary electrophoresis | In the process of implementation | Method details | [[64], [65], [66]] |
| Annex 12/0982 | Analytical sieving | In the process of implementation | Chinese Pharmacopoeia includes the manual sieving method; the ICH guideline includes the sonic-sifter sieving method | [[64], [65], [66]] |
| Annex 13/0993 | Bulk density and tapped density of powders | In the process of implementation | No changes | [[64], [65], [66]] |
| Annex 14/1145 | Bacterial endotoxins test | In the process of implementation | Method description | [64,66] |