Dissolution testing measures the rate and extent to which an active pharmaceutical ingredient (API) is released from a solid dosage form (tablet, capsule) into a dissolution medium. It is a critical quality control test defined in Ph. Eur. 2.9.3 and USP <711>, essential for batch release and demonstrating bioequivalence. Ovalab provides GMP-compliant dissolution testing for pharmaceutical manufacturers.
Key Facts About Dissolution Testing
- Pharmacopoeial methods: Ph. Eur. 2.9.3 (Dissolution test for solid dosage forms) and USP <711> define standardized apparatus, media, and acceptance criteria.
- Standard apparatus: Apparatus 1 (basket) and Apparatus 2 (paddle) are the most commonly used. USP also defines Apparatus 3 (reciprocating cylinder) and Apparatus 4 (flow-through cell).
- Regulatory role: Dissolution testing is required for marketing authorization (EMA) and batch release under GMP. Comparative dissolution profiles (f₂ similarity factor ≥ 50) are required for bioequivalence studies.
- Media: Standard dissolution media include pH 1.2 (0.1 N HCl), pH 4.5 (acetate buffer), and pH 6.8 (phosphate buffer), simulating gastrointestinal conditions.
- Acceptance criteria: Typically Q ≥ 80% dissolved in 30 or 45 minutes for immediate-release products (per individual monographs).
Testing Methods at Ovalab
Ovalab performs dissolution testing using calibrated paddle and basket apparatus per Ph. Eur. 2.9.3 and USP <711>. Analysis of dissolved API is conducted by HPLC or UV spectrophotometry. Testing operates under GMP certification (SÚKL 74726/2023) and ISO/IEC 17025:2017 accreditation (ČIA 537/2025), ensuring results are accepted for batch release and regulatory submissions.
Frequently Asked Questions
What is the purpose of dissolution testing?
Dissolution testing ensures that a solid dosage form releases its active ingredient at the intended rate. It serves as a quality control tool for batch release, a key parameter in bioequivalence studies, and a method to detect manufacturing variations.
What is the f₂ similarity factor?
The f₂ factor is a mathematical comparison of two dissolution profiles. A value ≥ 50 indicates similarity between test and reference products. It is required by EMA for bioequivalence studies and post-approval changes.
Which apparatus does Ovalab use?
Ovalab uses Apparatus 1 (basket) and Apparatus 2 (paddle) as specified in Ph. Eur. 2.9.3 and USP <711>. The choice of apparatus depends on the dosage form and the relevant pharmacopoeial monograph.
Can Ovalab perform dissolution profiling at multiple pH values?
Yes. Ovalab conducts dissolution testing at pH 1.2, 4.5, and 6.8 as required by EMA guidelines for bioequivalence studies, providing complete dissolution profiles for regulatory submissions.
Is dissolution testing required for generic medicines?
Yes. EMA requires comparative dissolution testing (f₂ similarity) between generic and reference products as part of bioequivalence assessment. Additionally, routine dissolution testing is required for every batch released under GMP.