Particle size analysis

Pharmaceutical Technology Europe

Volumn 21, Issue 4, 2009, Pages 20-24

  Kippax, Paul ^a  

^a MALVERN INSTRUMENTS LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ACCURACY; ANALYTIC METHOD; ARTICLE; BIOTECHNOLOGY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG LEGISLATION; DRUG MARKETING; DRUG QUALITY; DRUG RESEARCH; DRUG SOLUBILITY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; MEASUREMENT; PARTICLE SIZE; PHARMACOLOGICAL PARAMETERS; PHYSICAL CHEMISTRY; QUALITY CONTROL; REPRODUCIBILITY; SAMPLING; STANDARDIZATION;

EID: 65249084944     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. ICH Topic Q6A - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, December 2000. www.ich.org
2. D.J. Burgess et al., AAPSJ., 6(3), article 20 (2004).
3. H. Merkus "Quality Assurance in Particle Size Measurement" from Improving Standards in Particle Size Distribution Measurement, Engineering Research Centre for Particle Science and Technology (Gainsville, FL, USA, February 1997).
4. General Chapter <429> (2008), "Light Diffraction Measurements of Particle Size," United states Pharmacopeia. www.usp.org
5. European Pharmacopoeia, Chapter 2.9.31, Laser Diffraction Measurement of Particle Size, Supplement 5.6 (2006), p 4429. www.edqm.eu
6. FDA Draft Guidance - Analytical Procedures and Methods Validation, August 2000. www.fda.gov
7. D.J. Wheeler, How to Establish Manufacturing Specifications (2003). www.spcpress.com