000 02452cam a22004454a 4500
001 3824
003 BD-DhEWU
005 20190227150354.0
008 080729s2003 nyua g b 001 0 eng d
010 _a 2002035194
020 _a0824708857 (alk. paper)
020 _a9780824708856
035 _a(OCoLC)50851952
040 _aDLC
_cDLC
_dDLC
_dBD-DhEWU
_beng
041 _aeng
050 0 0 _aRS201.P37
_bA54 2003
082 0 0 _a615.19
_bAKP 2003
100 1 _aAkers, Michael J.
_98677
245 1 0 _aParenteral quality control :
_bsterility, pyrogen, particulate, and package integrity testing /
_cMichael J. Akers, Daniel S. Larrimore, Dana Morton Guazzo.
250 _a3rd ed.
260 _aNew York :
_bMarcel Dekker,
_cc2003.
300 _aix, 389 p. :
_bill. ;
_c24 cm.
440 0 _aDrugs and the pharmaceutical sciences ;
_vv. 125
_921405
504 _aIncludes bibliographical references and index.
505 _tTOC
_a1. Sterility testing -- 2. Pyrogen testing -- 3. Particulate matter testing -- 4. Package integrity testing -- Appendixes: -- I. Example of standard operating procedure for sterility testing by direct inoculation -- II. Example of standard operating procedure for sterility testing by membrane filtration -- III. Aseptic procedures at the laminar flow workbench.
520 _aSummary: Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities.
526 _aPharmacy
590 _aSagar Shahanawaz
650 0 _aParenteral solutions
_xAnalysis.
_98678
650 0 _aParenteral solutions
_xStandards.
_98679
650 0 _aPharmaceutical industry
_xQuality control.
_91081
700 1 _aLarrimore, Daniel S.,
_d1975-
_98680
700 1 _aGuazzo, Dana Morton.
_98681
856 4 2 _3Publisher description
_uhttp://www.loc.gov/catdir/enhancements/fy0647/2002035194-d.html
856 4 2 _3WorldCat details
_uhttp://www.worldcat.org/title/parenteral-quality-control-sterility-pyrogen-particulate-and-package-integrity-testing/oclc/50851952&referer=brief_results
856 4 2 _3E-book Fulltext
_uhttp://lib.ewubd.edu/ebook/3824
942 _2ddc
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_02
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