Search

1. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Drug Contamination
Particulate Matter
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2010

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration