💧 Dissolution (Comparative Dissolution Profile) — Quick Concept & Beginner Guide
📘 Quick Concept
What is a Comparative Dissolution Profile (CDP)?
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Comparative Dissolution Profile (CDP)
A CDP measures the % of API released from a Test product against a Reference (innovator/comparator) product, at the same series of time points (e.g. 5, 10, 15, 20, 30, 45, 60 min), typically across 12 units each. It's the core study used to demonstrate that a generic or reformulated product releases its drug the same way as the reference.
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Why CDP Uses f2
A CDP's two profiles are compared using the f2 similarity factor — a logarithmic measure of closeness between the Test and Reference curves. f2 between 50 and 100 means the profiles are similar. f2 is generally not required when both products release ≥ 85% within 15 minutes, since fast-dissolving profiles are inherently similar.
💡 Beginner Tip
Beginner Tips — How to Use This Calculator
- Standard Weight: The accurately weighed mass of your reference/working standard, from the balance record.
- Dilution Factor: The combined dilution factor used in your standard/sample preparation, per your SOP.
- Standard Potency: From your reference standard's Certificate of Analysis (CoA).
- Label Claim: The API content stated on the product label, per tablet/capsule.
- Instrument Type: Choose HPLC if you're reading Peak Area, or UV-Vis if you're reading Absorbance — all labels on the page update to match.
- Factor (if have): Optional. Leave blank if your method doesn't use an extra correction factor — treated as 1.00.
- Covering Standard: Optional, found inside each Test/Reference panel. If you injected extra "covering" standards alongside that product's samples, add them here — they combine with the System Suitability readings above for that panel's own average and %RSD.
- System Suitability: Enter each standard injection/reading (5 by default) — add or remove rows as your SOP requires. The average is used in the % Result formula.
- Time Points & Units: Add a block for each dissolution time point. Each block has 12 unit rows by default — enter Area/Absorbance per unit; % Result is calculated automatically.