by Q4A- Pharmacopoeial Harmonisation.
Q4B- Evaluation and Recommendations of Pharmacopoeial Texts for Use in the ICH Regions.
Q4B(R1)- Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
Q4B Annex 1 (R1)- Reduce on Ignition/ Sulphated Ash General Chapter.
Q4B Annex 2(R1)- Test for Extractable Volume of Parenteral Preparations General Chapter.
Q4B Annex 3(R1)- Test for Particulate Contamination: Sub-Visible Particles General Chapter.
Q4B Annex 4A(R1)- Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter.
Q4B Annex 4B (R1)- Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter.
Q4B Annex 4C (R1)- Microbiological Examination of Non-Sterile Products: Acceptances Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter.
Q4B Annex 5(R1)- Disintegration Test General Chapter.
Q4B Annex 6- Uniformity of Dosage Units General Chapter.
Q4B Annex 7(R2)- Dissolution Test General Chapter.
Q4B Annex 8(R1)- Sterility Test General Chapter.
Q4B Annex 9 (R1)- Tablet Fribility General Chapter.
Q4B Annex 10(R1)- Polyacrylamide Gel Electrophoresis General Chapter.
Q4B Annex 11- Capillary Electrophoresis General Chapter.
Q4B Annex 12- Analytical Seiving General Chapter.
Q4B Annex 13- Bilk Density and Tapped Density of Powders General Chapter.
Q4B Annex 14- Bacterial Endotoxins Test General Chapter.
