Release testing is a process that ensures the quality and safety of oral thin film pharmaceutical products before they enter the market, including the release testing of raw materials used in the production of oral thin film, the release testing of intermediates, and the release testing of finished products. CD Formulations brings many years of experience and expertise to the analytical testing of a wide range of oral thin film raw materials, intermediates and finished pharmaceutical products, providing release testing services to customers. We strictly adhere to cGMP and provide our customers with the highest quality standards to ensure oral thin film quality.

What is Oral Thin Film Release Testing?

The release testing of oral thin film raw materials, intermediates and finished products is a comprehensive process that ensures the safety, efficacy, and quality of oral thin film products used in pharmaceutical formulations. This testing typically requires an analytical evaluation of chemical, physical, and biological product quality based on a validated compendial (e.g., USP) testing strategy to address product purity, concentration, consistency, identity, and safety. Typical testing includes appearance, analysis and impurity, dissolution, and microbiological testing. Release testing is a crucial step in ensuring the quality and safety of oral thin film products before they enter the market.

Our Oral Thin Film Raw Materials, Intermediates and Finished Products Release Testing

The release testing is crucial for the quality control of oral thin film products, and it involves a series of quality control tests to ensure that the raw materials, intermediates, and finished products meet specified quality standards for safety, efficacy, and quality before they enter commercial distribution.

Fig.1 Our Oral Thin Film Release Testing Services. (CD Formulation)

Release Testing of Raw Materials

Before oral thin film manufacturing, the raw materials used in oral thin film manufacturing (including excipients, active pharmaceutical ingredients (APIs), and any additives) need to be tested to ensure that their physical and chemical properties, purity, and content meet the quality standards.

Release Testing of Intermediates

In the production process of the oral thin film, we characterize the physical and chemical properties, stability, etc., of the intermediates to ensure consistency and quality before the final formulation.

Release Testing of Finished Product

The final steps involve comprehensive testing of the finished oral thin film product to ensure that the finished product falls within the specifications determined, and release testing analysis services of the oral thin film include:

• Pharmacopeia Testing
• Biological Properties Evaluation
• Physicochemical Properties Analysis
• Mechanical Properties Analysis
• Identification
• Assay
• Related Substances
• Impurities (Residual Solvents, Metals)
• Microbial Limits
• Moisture Analysis
• In-Vitro Release Testing
• In-Vitro Dissolution and Disintegration Testing
• ICH Stability Testing

Advantages of Our Oral Thin Film Release Testing

• We have extensive experience working with multiple types of oral thin film and have the flexibility and broad instrumentation capabilities, flexible protocols, and study designs.
• We are equipped with state-of-the-art equipment, such as LC/MS/MS, HPLC (UV, PDA, FLU, ELSD, RI), UPLC (TUV, PDA, SQD), ACQUITY UPLC H-Class, GC, GPC, SEC, KF, TOC, Maldi-Tof, APSD (NGI, ACI), etc.
• We provide complete clearance records as required by the regulatory authorities, these records follow the attributable, legible, contemporaneous, original, accurate, and traceable.

CD Formulation is very experienced in the release testing of oral thin film, working with you to conduct your oral thin film release testing to provide a positive impact on your oral thin film products to market, avoiding unnecessary costs or delays. If you require our oral thin film raw material, intermediates and finished products release testing services, please contact us by phone or email, and our colleagues will get back to you within three working days.