Stability testing in an integrated scheme

Accreditation and Quality Assurance

Volumn 11, Issue 10, 2006, Pages 489-495

  Bremser, Wolfram ^a   Becker, Roland ^a   Kipphardt, Heinrich ^a   Lehnik Habrink, Petra ^a   Panne, Ulrich ^a   Töpfer, Antje ^a  

^a BAM FEDERAL INSTITUTE FOR MATERIALS RESEARCH AND TESTING   (Germany)

Author keywords

Arrhenius model; Certified reference materials; ERM; Shelf life; Stability

Indexed keywords

EID: 33750149701     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00769-006-0152-6     Document Type: Article

References (6)

1. ISO Guide 35: 2006. ISO. Geneva, Switzerland
2. Stability Testing of Drug Substances and Drug Products (Guidance for Industry), U.S. Food and Drug Administration, June 1998
3. Lamberty A, Schimmel H, Pauwels J (1998) Fres J Anal Chem 360:359-361
4. Heydorn K (1998) Accred Qual Assur 3:111-114
5. Guide to the Expression of Uncertainty in Measurement (1995) ISO. Geneva, Switzerland
6. Becker R, Buge H-G, Bremser W, Nehls I (2006) Anal Bioanal Chem 385:645-651