When a product is exposed to light beyond appropriate level , the active principle in a drug formulation and final product or package becomes toxic. This is why Photostability testing is important to ensure that the light exposure does not lead to unacceptable changes in dosage form. It studies the effect of light on the stability of pharmaceutical products,cosmetics and new active substances. The Photostability study evaluates any possibility of photodegradation that leads to bleaching or discoloration of product , loss of viscosity of formulation, degradation of active principle and alteration in dissolution rate.
Sunlight may induce interaction between drug molecules and endogenous substrates, convert the drug into toxic decomposition products or induce formation of reactive oxygen species which may further contribute to oxidative breakdown and toxicity to human tissues and loss of product potency.
During the course of drug/cosmetic development, investigations are made of the stability of active/drug substances and products to a range of stress factors such as heat, pH, oxidizing conditions and light (photosensitivity and photo-degradation). In addition to meeting regulatory requirements, these investigations provide valuable information which may aid the selection of formulation, product-pack combinations or the recommended storage conditions. Regulatory authorities usually require a statement on the photostability of products and the means of protection.
During a photostability study, characteristics are evaluated to demonstrate that unacceptable changes do not result from light exposure. It does offer regulatory compliance and meet product safety & efficacy standards. It prevents post-market product recall problems related to stability. cGMP photostability testing is an integral part of stress testing required under International Council for Harmonisation (ICH) Q1B.
Photostability studies evaluate the intrinsic photostability characteristics of new drug substances and products, in order to detect any product changes. This study informs the consumer about quality, efficacy, and safety of formulated products during manufacture, storage, distribution & use.
Products are exposed to artificial light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the substance and product as per ICH Q1B.
A systematic approach to photostability testing is recommended covering, as appropriate, studies such as:
In the Pharmaceuticals & Cosmetics industries the following products are tested.
Photostability studies carried out by using USFDA’s 21CFR compliant photostability chambers that meet ICH Q1B cumulative visible and UV light exposure requirements. A comprehensive range of advanced instrumentation is utilized to evaluate the overall photosensitivity and photo-degradation of active pharmaceutical and cosmetic products.
Costing and further product specific procedure please contact our business development team on [email protected]
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