Stability studies designed for international standards and customized for your product
Stability studies are a vital part of the development process, ensuring that a final product’s integrity or efficacy is not compromised. These studies don’t just help prove a product is safe and effective under a variety of conditions, they also establish its recommended storage conditions, shelf life, and compliance with international OTC regulations.
At CAPTEK Pharma, we know that every drug product is different, and we develop stability studies that are customized for the unique properties of your product’s characteristics and formulation.
Unmatched Softgel Stability Expertise
All of our stability studies are developed in accordance with ICH Q1A(R2) stability requirements and the ICH stability guidance. We can perform stability testing on bulk product or in your product’s marketing packaging.
Softgels in particular have special stability testing needs that must be addressed, including appearance, color, odor, hydrolysis, leakage, precipitation, cloudiness and many other factors. Only an experienced softgel manufacturer like CAPTEK has the analytical expertise required to develop effective softgel-specific stability studies, conduct them properly, and generate final reporting.
CAPTEK Pharma’s state-of-the-art facility includes stability chambers that provide the ideal testing environment for your custom stability study, with temperature and humidity uniform throughout the duration of the test. Each chamber has been qualified under IQ/OQ/PQ standards and has approved qualification reports available for review.
Speak With An Expert
Quality & Validation Specialist
Hiren offers 28 years of pharmaceutical development and manufacturing experience with emphasis on product/process development, validation and quality. Hiren also leads the quality unit and CAPTEK’s product development/validation team. With his oversight of product development, validation and quality at CAPTEK Pharma, Hiren is prepared to discuss any challenges on your upcoming project.