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>> Literature
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AKTIN Intellectual Property Protections
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Q1A(R2) Stability Testing of New Drug Substances and Products
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Q1B Stability Testing Photostability Testing of New Drug Substances and Products
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Q1C Stability Testing for New Dosage Forms
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Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
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Q1E Evaluation for Stability Data
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Q2(R1) Validation of Analytical Procedures Text and Methodology
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Q3A(R2) Impurities in New Drug Substances
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Q3B(R2) Impurities in New Drug Products
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Q3C(R8) Impurities：Guideline for Residual Solvents
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Q3D(R2) Guideline for Elemental Impurities
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Q4B Annex 1 (R1) Residue on Ignition/Sulphated Ash General Chapter
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Q4B Annex 2 (R1) Test for Extractable Volume of Parenteral Preparations General Chapter
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Q4B Annex 3 (R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter
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Q4B Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
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Microbiological Examination of Non-Sterile Products Tests for Specified Micro-Organisms General Chap
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Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparat
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Q4B Annex 5 (R1) Disintegration Test General Chapter
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Q4B Annex 6 Uniformity of Dosage Units General Chapter
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Q4B Annex 8 (R1) Sterility Test General Chapter
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