• ASTM E2363-05

ASTM E2363-05

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM International, 03/01/2005

Publisher: ASTM

File Format: PDF

$25.00$50.00


Published:01/03/2005

Pages:3

File Size:1 file , 56 KB

Note:This product is unavailable in Russia, Ukraine, Belarus

1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.

1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.

1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.

1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.

1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.

More ASTM standard pdf

ASTM E1840-96

ASTM E1840-96

Standard Guide for Raman Shift Standards for Spectrometer Calibration

$32.00 $65.00

ASTM A335/A335M-05a

ASTM A335/A335M-05a

Standard Specification for Seamless Ferritic Alloy-Steel Pipe for High-Temperature Service

$30.00 $60.00

ASTM Volume 04.13:2013

ASTM Volume 04.13:2013

ASTM Book of Standards Volume 4.13: Construction: Geosynthetics

$110.00 $221.25

ASTM D5057-90(1996)

ASTM D5057-90(1996)

Standard Test Method for Screening Apparent Specific Gravity and Bulk Density of Waste

$25.00 $50.00