ICH Photostability 测试 of 药品 & 生物制剂

im体育APP’s flexible and customized photostability and photodegradation protocols and study designs evaluate the intrinsic photostability characteristics of new drug substances and products, determining and monitoring how pharmaceuticals, therapeutics and biologics are affected by exposure to light over time.

The effects of degradation due to light exposure during manufacturing, storage and administration may result in the loss of 效力, altered efficacy and adverse biological effects for light-sensitive drugs and therapies. Photostability and photodegradation studies provide the critical data that is needed to assess light sensitivity and stability, in addition to determining the effectiveness of 包装 systems for small and large molecule light-sensitive formulations.

International Council for Harmonization (ICH) Q1B guidelines cite cGMP photostability testing as an integral part of stress testing requirements to ensure the quality, efficacy and safety of formulated products during manufacture, 储存与使用. 另外, ICH Q5C guidance for stability testing of biotechnological and biological products states that some biologics should be exposed to light as part of stability study condition parameters, as determined on a case-by-case basis. Therapeutic properties of biologic products can be affected significantly by subtle changes brought on by stress conditions the product is exposed to throughout the shelf life of the biologic, including exposure to light.

cGMP photostability testing and photodegradation studies

im体育APP’s comprehensive photostability testing programs are delivered by a consultative team with decades of experience following ICH Q1B guidelines and a wealth of up-to-date knowledge of regulatory guidance and standards. We use a wide range of advanced instrumentation, including Caron Photostability Chambers designed to meet ICH Q1B cumulative visible and UV light exposure requirements, to evaluate the photosensitivity and photodegradation of biopharmaceutical drug products and active pharmaceutical ingredients (APIs). Our photostability programs adhere to ICH guidance, whereby drugs must be exposed to at least 1.2 million lux-hours of visible light and 200 WHr/m2 of UVA (near UV) light.

In early stages of drug development, photodegradation studies can provide valuable information regarding the stability of light-sensitive formulations. Our ICH guideline-compliant photostability testing programs and testing protocols are customized to meet the specific requirements and needs of each product tested, and studies can be conducted to assess the effects of light exposure during handling and manufacturing.

im体育APP优势

Understand and characterize degradation pathways of light-sensitive biologics and pharmaceuticals with im体育APP’s extensive knowledge of light-induced degradation of APIs and drug products. As an experienced CDMO partner with proven success in developing, 验证, and transferring robust analytical methods for pre- and post- exposure stability studies, 在一起, we can improve product quality, 加快上市时间, and verify 包装 and exposure conditions for photosensitive substances.

To learn more about im体育APP’s ICH-compliant photostability and photodegradation studies for pharmaceuticals and biologics, or to speak with one of our experts, im体育APP 今天.