Home
About Us
Products
Services
Literature
What's News
Contact
Featured Products
+ Astragaloside IV
+ Alpha-Mangostin
+ Apigenin
+ Betulin
+ Betulinic acid
+ Cepharanthine
+ Luteolin
+ Puerarin
+ Cycloastragenol
+ Bakuchiol
Home
>> Literature
•
AKTIN Intellectual Property Protections
•
Q1A(R2) Stability Testing of New Drug Substances and Products
•
Q1B Stability Testing Photostability Testing of New Drug Substances and Products
•
Q1C Stability Testing for New Dosage Forms
•
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
•
Q1E Evaluation for Stability Data
•
Q2(R1) Validation of Analytical Procedures Text and Methodology
•
Q3A(R2) Impurities in New Drug Substances
•
Q3B(R2) Impurities in New Drug Products
•
Q3C(R8) Impurities：Guideline for Residual Solvents
•
Q3D(R2) Guideline for Elemental Impurities
•
Q4B Annex 1 (R1) Residue 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 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
•
Microbiological Examination of Non-Sterile Products Tests for Specified Micro-Organisms General Chap
•
Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparat
•
Q4B Annex 5 (R1) Disintegration Test General Chapter
•
Q4B Annex 6 Uniformity of Dosage Units General Chapter
•
Q4B Annex 8 (R1) Sterility Test General Chapter
<<
1
2
3
>>
