PHOTOSTABILITY TESTING OF PHARMACEUTICAL PRODUCTS

Implications of Photostability on the Manufacturing , Packaging , Storage , and Testing of Formulated Pharmaceutical Products

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study. hotostability testing in the pharmaceutical industry has evolved rapidly, particularly since the May 1997 publication of the ICH Q1B guidance “...

Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products.

The ICH Q1B guidance and additional clarifying manuscripts provide the essential information needed to conduct photostability testing for pharmaceutical drug products in the context of manufacturing, packaging, and storage. As the previous 2 papers in this series highlight for drug products administered by injection (part 1) and drug products administered via topical application (part 2), there...

Comparison of endotoxin testing methods for pharmaceutical products.

Bioluminescence for USP sterility testing of pharmaceutical suspension products.

Bioluminescence measurement significantly improved the accuracy, sensitivity, precision, and reliability of the current visual endpoint determination for the USP sterility test and eliminated the day 7 transfer/dilution step required for testing suspension products. Thirteen strains of bacteria and fungi (representing potential contaminants in sterile products), three pharmaceutical suspension ...

Roughness Model for Adhesion Testing of Pharmaceutical Coating Materials

Objective Roughness is the main parameter in interlocking bonding mechanism. Yet there is no model designed to evaluate the effect of surface roughness on adhesion of coating materials in pharmaceutical sciences. Materials and Methods In this study polymethyl metacrylate spherical beads with different sizes were poured into 10 mm mold, then it was pressed by hand screw and finally heated to 141...