title: Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection.
abstract: Basic guidance on the photostability testing of pharmaceuticals, designed to cover manufacturing and storage over shelf life, has long been established within ICH Q1(ICH,B(10) , but the guideline does not cover the photostability of drugs during or after administration (i.e., under conditions of use). To date, there has been a paucity of guidance covering the additional testing that would be of value during the clinical preparation and use of products. This commentary suggests a systematic approach, based on realistic "worst case" photoexposure scenarios and the existing ICH Option 1 and 2 light sources, to provide valuable data to pharmaceutical manufacturers and compounding pharmacists for the safe and effective use of photosensitive injection products.
authors.affiliation: Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, Indiana, 46285.
authors.forename: Steven W
authors.initials: SW
authors.lastname: Baertschi
authors.forename: David
authors.initials: D
authors.lastname: Clapham
authors.forename: Chris
authors.initials: C
authors.lastname: Foti
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Jansen
authors.forename: Solveig
authors.initials: S
authors.lastname: Kristensen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Reed
authors.forename: Allen C
authors.initials: AC
authors.lastname: Templeton
authors.forename: Hanne Hjorth
authors.initials: HH
authors.lastname: Tønnesen
mesh_terms: D004348:Drug Labeling / Q000379:methods / Q000592:standards; D004355:Drug Stability; D006801:Humans; D007267:Injections; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry; D010782:Photolysis; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations
keywords: chemical stability; injectables; photochemistry; photodegradation; physical stability; preformulation; stability