Photostability Testing of Pharmaceutical Products Per ICH Q1B Guidelines
A number of drugs are sensitive to light, and as a result, their formulated products may degrade during manufacturing, storage, and administration. The effects of degradation due to light exposure may result in loss of potency, altered efficacy, and adverse biological effects. Photostability testing is needed to assess biopharmaceutical drug products and substances for light sensitivity and stability. Additionally, photostability studies are a critical tool in determining the effectiveness of specific packaging systems for light-sensitive pharmaceutical drugs.
During a photostability study, characteristics are evaluated to demonstrate that unacceptable changes do not result from light exposure. cGMP photostability testing is an integral part of stress testing required under International Council for Harmonisation (ICH) Q1B, which ensures the quality, efficacy, and safety of formulated products during manufacture, storage, and use. Our comprehensive photostability testing evaluates the intrinsic photostability characteristics of new drug substances and products, in order to detect any product changes.
Flexible and customized protocols and study designs that determine and monitor the effects of light on biopharmaceuticals, pharmaceuticals, and therapeutics over time.
Decades of experience following ICH Q1B guidelines with up-to-date knowledge of regulatory guidance and standards.
Extensive knowledge of light-induced API degradation and proven success developing, validating, and transferring sophisticated analytical methods for pre- and post- exposure stability studies.
cGMP Photostability Testing & Photodegradation Studies
We work with our partners to tailor our ICH Q1B guideline-compliant, comprehensive photostability testing programs to their specific requirements and needs, offering compliant customized testing protocols. A wide range of advanced instrumentation is utilized to evaluate the overall photosensitivity and photodegradation of active pharmaceutical ingredients and biopharmaceutical drug products. Photostability studies utilize Caron Photostability Chambers that are designed to meet ICH Q1B cumulative visible and UV light exposure requirements.
Avomeen’s photostability programs adhere to ICH guidance which states that drugs must be exposed to at least 1.2 million lux-hours of visible light and 200 WHr/m2 of UVA (near UV) light. Q1B does not specify either temperature or humidity parameters during testing, other than to require “appropriate” control of temperature to “minimize…localized temperature changes”.
ICH Q1B guidelines allow for two light source options for photostability testing of pharmaceutical products. Option I testing is performed with a wide-range light source, encompassing both near UV (UVA) and visible light spectra. The light source is typically either fluorescent D65, xenon or metal halide (HID). Option II uses two different lamp types, fluorescent cool white lamps for VIS exposure and near UV fluorescent lamps (320 nm to 400 nm) for UVA exposure.
Rigorous Quality & Compliance to ICH Q1B Photostability Standards
Avomeen’s stability testing team combines experienced, Ph.D.-backed scientists with leading technology and uncompromising quality to deliver comprehensive photostability testing and programs to life science companies serving a diverse range of market segments. Our regulatory and industry experts carefully and securely monitor products throughout photostability testing programs in an organized and controlled environment.
Together, we can improve product quality, speed to market, and verification of correct packaging and exposure for photosensitive substances. Get in touch with an expert to explore a partnership with Avomeen.