Consistent release. Reliable results.
At Sciom, dissolution testing is integrated across product development, quality control, and stability studies to evaluate consistent drug release and in vitro performance across batches and strengths. It supports formulation optimisation, biopharmaceutical understanding, and the generation of dissolution data required for regulatory submissions and post-approval changes.
End-to-end dissolution capabilities.
Sciom provides advanced dissolution testing services to evaluate drug release performance, ensuring consistency, regulatory compliance, and reliable product quality across all dosage forms.
Dissolution Method Development: Custom method development tailored to formulation characteristics and regulatory expectations
Method Validation: Full validation in line with ICH and pharmacopeial requirements to ensure accuracy, precision, and robustness
Dissolution Profiling: Comparative and discriminative profiling to assess drug release behavior across batches or formulations
Routine QC Dissolution Testing: Batch release and stability testing to ensure consistent product performance
Comparative Dissolution Studies: Including testing for over-encapsulated products to support clinical and regulatory requirements
Disintegration Testing: Supporting dissolution studies with additional performance insights where required
Dosage Form Expertise: Testing for tablets, capsules, and softgels using USP Apparatus 1 (basket) and Apparatus 2 (paddle)
Clear workflow. Consistent outcomes.
Dissolution testing objectives are defined based on product requirements and guidelines, including QC testing, biowaiver support, and comparative profiling. Media selection, apparatus, and acceptance criteria are established to ensure suitability.
Testing conditions such as media, rotation speed, temperature, sampling time points, and filtration are optimised to develop a robust and discriminatory dissolution method suitable for routine QC use.
Validation is performed to assess accuracy, precision, robustness, filter and media suitability, and sample stability, ensuring the method is fit for its intended purpose.
Dissolution testing is conducted for single-point QC and multi-point profiling across development, bio-batches, scale-up, site changes, and stability studies.
Results are evaluated using statistical tools such as f2 similarity factors where applicable, with trends monitored over time. Clear reports are prepared to support CTD submissions and variation dossiers.
Standards met. Confidence built.
Dissolution strategies aligned with EMA, MHRA, and ICH expectations for QC methods, biowaiver justifications, and post-approval changes
Methods designed and validated in accordance with USP/Ph. Eur./ICH principles for robustness and suitability for routine control
Reporting structured to support Module 3 requirements, including profiles, justification of conditions, and method validation summaries
Supports regulatory submissions, stability studies, and batch release testing.
Deep expertise. Reliable release data.
Dissolution testing is designed using discriminatory methods tailored to formulation characteristics and critical quality attributes (CQAs), enabling accurate evaluation of drug release behaviour. Multiple media conditions, including varied pH ranges and surfactants where appropriate, are applied to characterise release profiles under relevant conditions.
Comparative dissolution profiles are generated across different strengths, formulations, and manufacturing changes to support consistent product performance. Dissolution data is integrated with stability, impurity, and assay results to provide a comprehensive understanding of overall product quality.
Testing is performed using USP Apparatus 1 (basket) and Apparatus 2 (paddle), supporting a wide range of dosage forms and ensuring reliable and reproducible results.
Proven expertise. Consistent results.
Sciom provides end-to-end dissolution testing support, from method development and validation through to routine QC testing and stability studies. Methods are designed to ensure consistent drug release performance across batches and throughout the product lifecycle.
Experience covers a wide range of dosage forms, including tablets, capsules, softgels, suspensions, and over-encapsulated products. Dissolution testing is integrated into batch release, stability programmes, and development studies, supporting regulatory requirements and lifecycle management, including post-approval changes.
Dissolution data is evaluated alongside assay, impurity, and stability results to provide a comprehensive understanding of product performance. Clear reporting and structured data tracking support informed decision-making throughout development and routine use.
Everything you need. One trusted partner.
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