Free E-Book
Quality Control Tests for Soft Capsules: A Comprehensive Guide
Soft capsules present a fascinating challenge for quality control professionals in ensuring the safety, efficacy, and stability of these innovative dosage forms. In this free e-book, we discuss the quality control tests, the monographs that describe these requirements, and the acceptance criteria for each test. We also give insights about the comparability of the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP/Ph.Eur.) monographs and indicate additional recommended testing parameters beyond the pharmacopeial requirements.
What You’ll Get in this Free Guide
Ph. Eur vs. USP Requirements on Testing of Soft Capsules
Understand the similarities and differences between quality control tests for soft capsules in the European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP), including uniformity of dosage units, disintegration, dissolution, and microbial quality.
Technical Requirements and CQAs
Learn about the specific critical quality attributes for soft capsules beyond the pharmacopeial requirements, and understand how to define the CQAs based on the unique characteristics of the drug substance and the formulation concept.
Applicable ICH guidelines
Get an overview of the relevant ICH guidelines that impact the quality control strategy for soft capsules, such as ICH Q3B (impurities), ICH Q6A (specifications), and ICH Q8 (pharmaceutical development). Learn how to apply these guidelines to define the specification limits for assay, degradation products.
Dissolution testing of soft capsules
Understand the complex topic of dissolution testing for soft capsules, and learn practical tips and best practices for developing and validating robust dissolution methods for soft capsules.
From our e-book:
“The disintegration test plays a crucial role for soft capsules, as the disintegration is the first limiting step for the release of the capsule fill mass. Several monographs in the Ph. Eur. and USP provide information on disintegration testing. The two pharmacopeias have very similar requirements for the tests and the disintegration apparatus. Both pharmacopeias state that you should conduct the test for immediate-release capsules on 6 units using water or, in justified cases, 0.1N HCl; however, you may encounter some differences. Gastro-resistant capsules must meet additional requirements.”
Why work with us
Despite a century of industrial production, softgel capsules remain poorly understood. Each formulation presents unique challenges, demanding expertise in excipients, processes, analysis, and regulations for success. Bringing together the best practices in soft gel development, we stand as independent experts with real solutions.
Mitigate softgel capsule quality control risks
Avoid risks in the development process. We consider critical aspects for the entire capsule from day one following our structured, risk-based approach tailored for soft gel capsules.
Become the expert for your soft gel product
We support you in finding the critical factors for your softgel product and ensure complete development documentation. With our expertise, our team is there to empower your product.
Prepare state-of-the-art CMC documentation
Uncertain about regulatory expectations, or which agencies to see? We enhance your soft gel CMC documentation and prepare CMC sections for your IND/IMPD file in CTD format.
Partner with top-tier quality control experts
Optimize your quality control strategy and lead efficient negotiations with our extensive partner database for the development and analytical services needed for the quality control of soft gel capsules.
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