BASF Kollidon CL
- PharmAssess™ GMP Audit
About BASF Kollidon CL
BASF was founded in 1865 and is one of the world’s largest producers of fine chemicals.
Kollidon® CL has long been celebrated as a truly superlative disintegrant.
To meet differing customer requirements, BASF is now launching two additional grades, called Kollidon® CL-F and Kollidon CL-SF.
Kollidon® CL-F is a fine grade with a mean particle size of 29 µm, while Kollidon® CL-SF is a superfine grade with a mean particle size of 17 µm. Thanks to its fine particle size, with a concomitantly excellent mouth-feel, Kollidon® CL-SF is an optimal disintegrant for fast-dispersible tablets. Besides the particle size, the various Kollidon® CL grades also differ in terms of their water uptake capacities.
In addition to their disintegrative power, all Kollidon® CL grades enhance the solubility of many active ingredients.
BASF also offers Kollidon® CL-M, a micronized grade that acts as a suspension stabilizer.
All Kollidon® CL grades meet the requirements of Ph.Eur., USP-NF, JPE, and are produced under c-GMP conditions.
About the Audit
BASF Kollidon CL was audited between 8 - 9 November 2007. The Report is 27 pages long, excluding appendices. Including appendices, the Report is 47 pages long.
The Audit Report provides information on the site facilities and covers a wide range of cross-linked materials, and BASF’s expertise is in the cross-linked polymerisation of N-vinylpyrrolidone to produce the Kollidon CL polymer, including; Crospovidone C, Kollidon CL, Kollidon CL-F, Kollidon CL-SF, Kollidon CL-M, Kollidon CL-CY.
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