Stability Testing is the process for determining, through storage at defined conditions and testing at specific intervals, how long a drug substance or product remains safe and effective at storage conditions. CD Formulation's teams manage state-of-the-art laboratories, equipped with stability storage rooms, and mapped and continuously monitored using a proven continuous monitoring system to extend the shelf life of your medicines and ensure regulatory compliance with our stability testing and storage services.

The Importance of Stability Testing for Oral Thin Film

Because the skeleton of oral thin films is mainly polymer, which are easy to absorb moisture, special attention needs to be paid to the stability of the oral thin films. The stability program of oral thin films is one of the important measures to ensure the quality and efficacy of oral thin film drug delivery systems. Through the development of scientific and reasonable stability test plan and method, the stability of oral dissolved film can be evaluated under different storage conditions, and provide guidance for the production, packaging and storage of oral thin films. Therefore, developing a drug stability program is very important for both oral thin film manufacturers and regulatory authorities.

Our Oral Thin Film Stability Testing

CD Formulation provides customized storage conditions and frequently introduces new storage options to expand our capabilities. We conduct tests tailored to our clients' needs. Whether we follow customer-provided methods, pharmacopoeia methods, or those developed and validated by our own analysts, these facilities can meet the requirements of stability studies, shelf-life testing, and shelf life determination. We provide efficient research management, flexible storage conditions and testing capabilities to meet your real-time stability testing, including long-term, intermediate, accelerated, forced degradation, photostability, etc.

Available ICH Stability Conditions

We have an extensive range of ICH pharmaceutical stability storage stability conditions spanning the ICH climatic zones and also bespoke storage capabilities:
21℃ / 45% RH
25℃ / 40% RH
25℃ / 60% RH
30℃ / 25% RH
30℃ / 35% RH
30℃ / 65% RH
30℃ / 75% RH
40℃ / 75% RH
40℃ / NMT 25%RH
Cabinets 50℃, 57℃, 60℃
Storage at 2-8℃
ULT storage -20℃, -40℃, -80℃
ICH Photostability (ICH Q1B Photostability Options 1 & 2)
Specialised conditions
Freeze/thaw temperature cycling tests

Our Advantages in Oral Thin Film Stability Testing

• We have sufficient capacity to respond to emergencies, and in the event of a power failure, our laboratory and monitoring systems are supported by external backup generators.
• Our stability storage rooms are equipped with a proven continuous monitoring system.
• Following the ICH stability testing guidelines, our analytical laboratory utilizes a range of techniques to develop and validate stability indication methods to identify and quantify degradation products.
• We provide customized storage conditions and often introduce new storage options to expand our capabilities.
• We have professional stability researchers who check all stability samples before starting any stability study.
• We have strong analytical teams to analyze samples at routine time points for stability studies.

Published Data

With years of experience in stability research combined with a comprehensive understanding of the latest developments in regional, national and ICH stability research guidelines, CD Formulation provide truly flexible stability testing services. If you have a requirement about our oral thin film stability testing services, please contact us by phone or email, our colleagues will reply to you within three working days.