Regulatory-Compliant Photostability Studies by Neopharm

Neopharm specializes in conducting compliant photostability studies to assess the effect of light quickly and accurately on the quality, stability, and performance of your products.

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Our state-of-the-art, fully validated chambers are designed to meet the rigorous standards outlined in the ICH Q1B guideline, Option 2. We offer protocol assistance and study design support to ensure that your photostability studies are conducted effectively and in accordance with regulatory requirements. Trust Neopharm for reliable photostability testing that preserves the integrity of your products.


Compliance with Regulatory Guidelines

Photostability studies are a critical component of regulatory compliance for pharmaceutical, biotechnology, and medical device products. Our expertise in following the ICH Q1B guideline, Option 2 ensures that your studies are conducted in accordance with international regulatory standards. We help you demonstrate product stability and assess the potential impact of light on your formulations.

Product Quality and Shelf-Life Assessment

Light exposure can cause degradation, color changes, loss of potency, and other undesirable effects in pharmaceutical and cosmetic products. Our photostability studies provide valuable insights into the product's vulnerability to light-induced degradation. By evaluating the impact of different light sources and exposure durations, we help you determine appropriate packaging, storage, and labeling recommendations to maintain product quality and extend shelf life.

Protocol Assistance and Study Design

Our experienced team is ready to assist you with protocol development and study design tailored to your specific product requirements. We understand the importance of well-designed studies that consider factors such as light intensity, exposure duration, sample positioning, and control groups. With our guidance, you can confidently conduct photostability studies that generate reliable data and support regulatory submissions.

Neopharm Answers to Common Questions About Photostability Studies

At Neopharm, we strictly adhere to the International Conference on Harmonization (ICH) Q1B guideline, specifically Option 2, which outlines the conditions for conducting photostability studies. This guideline provides comprehensive guidance on the choice of light sources, exposure durations, and sample handling to ensure accurate and standardized testing.

Our photostability chambers undergo rigorous validation to ensure they meet the highest standards of performance and accuracy. We validate the chambers based on parameters such as temperature, humidity, light intensity, and uniformity of exposure. By using validated chambers, we can provide reliable and consistent results for your photostability studies.

Absolutely! Our team of experts has extensive experience in protocol development and study design for photostability studies. We collaborate closely with you to understand your product, regulatory requirements, and specific testing needs. Based on this information, we provide protocol assistance and design studies that align with industry best practices, ensuring robust and reliable results.

Photostability testing is applicable to a wide range of products, including pharmaceuticals, cosmetics, dietary supplements, and medical devices. It is particularly important for products that are likely to be exposed to light during storage, transportation, or usage. Our photostability studies can help assess the effects of light on product quality and provide valuable information for product development, formulation optimization, and labeling recommendations.

Preserve the quality and stability of your products with Neopharm's reliable Photostability Studies. Our fully validated chambers, adherence to regulatory guidelines, and expertise in study design ensure accurate and compliant testing. Contact us today to discuss your photostability testing needs and benefit from our experience in the life sciences industry.

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