PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms.
This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solid-dosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particle-size characterization (a table of acronyms is provided at the end of the document). It is acknowledged that each drug substance, formulation, and manufacturing process is unique and that multiple techniques and instruments are available to the analyst.
Snorek
Sharon M
SM
Eli Lilly & Company, Lilly Corporate Center, Indianapolis, Indiana 46285-0001, USA. snorek_sharon_m@lilly.com
Bauer
John F
JF
Chidambaram
Nallaperumal
N
Doub
William H
WH
Duffy
Eric P
EP
Etzler
Frank M
FM
Kelly
Richard N
RN
Lane
Justin J
JJ
Mueller
Ronald L
RL
Prasanna
Hullahalli R
HR
Pujara
Chetan P
CP
Reif
Van D
VD
Scarlett
Brian
B
Stowell
Joseph G
JG
Toma
Pascal H
PH
D000284:Administration, Oral; D016477:Artifacts; D004345:Drug Industry; D008853:Microscopy; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012542:Scattering, Radiation; D013678:Technology, Pharmaceutical / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations