How to set specifications for the particle size distribution of a drug substance? Particle sizing

American Pharmaceutical Review

Volumn 12, Issue 3, 2009, Pages

  John, Edgar ^a  

^a Novartis Pharma AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG MANUFACTURE; DRUG PURITY; DRUG STABILITY; GOOD MANUFACTURING PRACTICE; LASER DIFFRACTION; PARTICLE SIZE; POWDER; REPRODUCIBILITY;

EID: 65949091813     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. ICH harmonised tripartite guideline: Specifications, Test procedures and acceptance criteria for new drug substances and new drug products, Step 4, International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. WWW.ICH.ORG (1999)
2. International Standard ISO 13320-13321: Particle size analysis - Laser diffraction methods. (1999)
3. European Pharmacopoeia EP 2.9.31: Particle size analysis by laser light diffraction. (2008)
4. John E., Bruehwiler M., Frei M. An attempt to quantify the de-agglomeration efficiency of ultrasonicators. Proceedings PARTEC 2001 (2001)
5. OECD Guideline for testing of chemicals 110: Particle size distribution/fibre length and diameter distributions. (1981)
6. BCR information: Certification report on reference materials of defined particle size, EUR 6825. Commission of the European Communities (1980)
7. John E. How to set a specification for particle size distributions? Proceedings PARTEC 2004 (2004)