Dissolution Tester

Dissolution Tester

QualiPharma™ DIS & DIS SA Series — USP <711> / EP / JP / 21 CFR Part 11 Compliant

A Dissolution Tester is a precision pharmaceutical instrument that measures the rate and extent at which an active pharmaceutical ingredient (API) is released from its dosage form — tablet, capsule, modified-release matrix, transdermal patch — into a controlled aqueous medium that simulates physiological conditions. Dissolution testing is one of the most rigorously regulated and most frequently performed tests in pharmaceutical quality control: it predicts in-vivo bioavailability, confirms batch-to-batch consistency, supports bioequivalence claims for generic drugs, demonstrates GMP compliance during FDA pre-approval inspections, and provides the foundational data on which every NDA, ANDA, and Marketing Authorization Application depends.

Pharmacopeial standards codify dissolution testing with extraordinary precision. USP <711> Dissolution, USP <1092> Dissolution Procedure Development & Validation, EP 2.9.3, and JP 6.10 describe standardized apparatus configurations — Apparatus 1 (Basket), 2 (Paddle), 5 (Paddle-over-Disc), and 6 (Rotating Cylinder) — operating under defined conditions of 37 °C ± 0.5 °C bath temperature, precise rotational speed, and rigid hydrodynamic equivalence. Modern instruments must additionally satisfy FDA 21 CFR Part 11 electronic-record requirements, 21 CFR Part 211 cGMP laboratory controls, and ICH Q1A stability-testing protocols — delivering complete audit trails, electronic signatures, and tamper-proof records that pharmaceutical regulators now demand.

Qualitest offers a comprehensive four-platform QualiPharma™ Dissolution Tester portfolio. The QualiPharma™ DIS 2008 (Automated) is the entry 8-vessel automated platform for routine QC and R&D. The QualiPharma™ DIS 2014 (Advanced) is the 14-vessel comparative dissolution platform engineered for bioequivalence studies of generic vs innovator drug formulations. The QualiPharma™ DIS SA 2008 is the fully integrated 8-channel dissolution + automated sampling + media-replenishment system, combining an 8-channel imported precision syringe pump with multi-method dissolution apparatus, segmented-shaft design that eliminates height re-adjustment on method changeover, a square integrated water bath with arc corners and bottom-drain, and 21 CFR Part 11-aligned data integrity (40 user accounts, 3-tier access, encrypted audit trail, thermal printer). And the flagship QualiPharma™ DIS SA 2014 (Advanced) delivers production-ready FDA audit-ready performance: 316L stainless steel segmented propeller shaft, multi-point SS guide rod machine head, embedded fixing-hoop dissolution vessels, imported PTFE micro-transparent sampling pipelines, eight independent temperature probes (one per vessel), 10-inch color touchscreen, AIQ IQ/OQ/PQ certification services, and minimum 2-minute sampling interval for the most demanding ICH Q1A multi-point dissolution profiles.

Dissolve with Precision. Approve with Confidence.

In every pharmaceutical company on Earth, the dissolution tester is the gatekeeper of bioavailability — the silent instrument that decides whether a tablet will actually deliver its API as intended, whether a generic drug will achieve bioequivalence with its innovator reference, and whether a regulatory submission will pass FDA review or trigger a costly Refuse-to-File. A poorly performing dissolution program means failed batch releases, blocked product launches, GMP warning letters, recalled inventory, and lost market access. The pharmaceutical manufacturers, generic-drug developers, R&D scientists, and QC professionals who consistently launch compliant, bioavailable, regulator-approved products are the ones equipped with dissolution testers built for pharmacopeial accuracy, full automation, and FDA 21 CFR Part 11 data integrity — and the Qualitest QualiPharma™ portfolio gives you exactly that.

Whether you are running routine batch-release QC, supporting generic-drug bioequivalence studies, developing modified-release formulations, building a CRO contract-research operation, or preparing an NDA / ANDA / 505(b)(2) submission, Qualitest has the dissolution-testing platform engineered to meet your exact needs. From the entry QualiPharma™ DIS 2008 to the bioequivalence-ready DIS 2014 and the integrated QualiPharma™ DIS SA 2008 / QualiPharma™ DIS SA 2014 sampling-system flagships, every Qualitest dissolution tester delivers world-class regulatory-compliant performance backed by industry-leading service and support.