Development and validation of a particle size distribution method for analysis of drug substance

American Pharmaceutical Review

Volumn 5, Issue 3, 2002, Pages 86-91

  Lerke, Susan A ^a   Adams, Stuart A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; OIL; POLYSORBATE 80;

ACCURACY; ARTICLE; COMPUTER PROGRAM; COMPUTER SYSTEM; CONTROLLED STUDY; DISPERSION; DRUG BIOAVAILABILITY; DRUG MANUFACTURE; DRUG SOLUBILITY; DRUG STABILITY; DRY POWDER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMAGE ANALYSIS; IMMERSION; LASER DIFFRACTION; LIGHT SCATTERING; MEDICAL INSTRUMENTATION; METHODOLOGY; PARTICLE SIZE; POLARIZATION MICROSCOPY; REPRODUCIBILITY; SUSPENSION; ULTRASOUND; VALIDATION PROCESS;

EID: 0036742072     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. R. Ansell, A. Evans and E. Knight, "The Investigation of the Influence of Dispersion Techniques and Particle Characteristics in the Laser Diffraction Particle Sizing of Bulk Solids and Bulk Solid Mixtures", Proceedings of the Conference Seminars - Powder & Bulk Solids Conference, 219-227, May, 1996.
2. A. Rawle, "The Importance of Particle Size Analysis in the Pharmaceutical Industry", personal communication.
3. Instrument Vendor Manual, MAN0101 "Getting Started", January, 1996.
4. A. Jillavenkatesa, J. Kelly and S. Dapkunas, "Some Issues in Particle Size and Size Distribution Characterization of Powders", Am. Pharm. Rev., 5(2), 98-105, 2002.
5. C. Washington, "Particle Size Analysis in Pharmaceutics and Other Industries, Theory and Practice", Ellis Horwood Limited, 1992.
6. United States Pharmacopeia, "<776> Optical Microscopy", 25, 2002.
7. FDA, "General Principles of Validation", May, 1987.
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, "Text on Validation of Analytical Procedures", ICH Harmonised Tripartite Guideline Q2A, Recommended for Adoption at Step 4 of the ICH Process, 1994.
9. D. Barber, J. Keuter and K. Kravig, "A Logical Stepwise Approach to Laser Diffraction Particle Size Distribution Analysis Methods Development and Validation", Pharm. Dev. and Tech., 3(2), 153-161, 1998.
10. H. Brittain, "What is the 'Correct' Method to Use for Particte-Size Determination?", Pharm. Technol., 25(7), 96-98, 2001.
11. T. Allen, "Particle Size Measurement, Volume 1", Chapman &