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Preservative effectiveness testing

Large-volume parenterals (LVPs) and small-volume parenterals (SVPs) containing no antimicrobial agent should be terminally sterilized. It is common practice to include an antimicrobial agent in SVPs that cannot be terminally sterilized or are intended for multiple-dose use. The general exceptions are products that pass the USP Antimicrobial Preservative Effectiveness Test [1] because of the antimicrobial activity of the active... [Pg.396]

In some situations, it is advisable to have a preservative effectiveness test conducted on a preparation that may require routine compoimding or extended storage for some reason. [Pg.26]

The following principles apply to preservative effectiveness testing within a pre- and postmarketed product stability program. [Pg.224]

Preservative effectiveness testing should be included at the 3, 12, 24, and 36 months intervals for pilot validation batches or for the first three commercial batches of a new product. [Pg.227]

E. coli is recommended. The microbiological assessment of preservatives is required when preservatives are used in a pharmaceutical product to control microbial bioburden. The test microorganisms and methods for evaluating the efficacy of the preservative in pharmaceutical products are described in the general chapter on preservative effectiveness tests [26]. [Pg.551]

Japanese Pharmacopoeia (JP) (2001), Preservatives—Effectiveness tests, general information chapter 12, Society of Japanese Pharmacopoeia, Tokyo. [Pg.556]

Preservative Effectiveness Test carried out at lowest specified preservative level. [Pg.476]

Test documentation chemistry documentation Application/compendial product release requirements Preservative effectiveness test carried out at lowest preservative level... [Pg.770]

Preservative effectiveness test carried out at lowest preservative level... [Pg.770]

The test for antimicrobial effectiveness is used to demonstrate the effectiveness of any added antimicrobial preservative(s). Compendial references include USP 24 Chapter 51, Antimicrobial Effectiveness Test JP XIII, General Information 3, Preservatives-Effectiveness Tests and Ph. Eur. 3rd Ed., Biological Tests, 5.1.3., Efficacy of Antimicrobial Preservation. [Pg.2785]

USP-type preservative effectiveness test USP microbial limits test Shelf life-testing requirements Shelf life sterility... [Pg.179]

See other pages where Preservative effectiveness testing is mentioned: [Pg.474]    [Pg.551]    [Pg.8]    [Pg.494]    [Pg.308]    [Pg.1627]    [Pg.2988]    [Pg.120]    [Pg.302]    [Pg.8]    [Pg.343]    [Pg.313]    [Pg.314]    [Pg.22]   
See also in sourсe #XX -- [ Pg.1627 , Pg.2786 ]

See also in sourсe #XX -- [ Pg.120 ]



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Preservatives testing

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