Dissolution Tester
The Dissolution Tester is a sophisticated analytical apparatus integral to pharmaceutical quality assurance and regulatory compliance. It quantifies the dissolution behavior of solid oral dosage forms (e.g., tablets, capsules) under standardized conditions, simulating drug release in the human gastrointestinal tract. Operating in full alignment with international pharmacopeial guidelines (USP Apparatus 1/2, Ph.Eur. 2.9.3), the system employs precisely controlled temperature (±0.5°C), calibrated paddle/basket agitation, and automated sampling at programmable intervals.
Technical Specifications:
| Parameter | Specification |
|---|---|
| Agitator Oscillation Amplitude | ≤0.3 mm |
| Basket Oscillation Amplitude | ≤0.8 mm |
| Shaft-Vessel Alignment Error | ≤1 mm |
| Speed Adjustment Range | 20–200 rpm |
| Speed Resolution | 1 rpm |
| Water Bath Temperature Range | RT – 45°C |
| Temperature Resolution | 0.1°C |
| Temperature Control Accuracy | ≤±0.3°C |
| Pre-settable Sampling Cycles | 9 cycles |
| Sampling Cycle Duration* | 1–999 min/cycle |
| Timing Error | ±0.5 min |
| Pharmacopoeia Parameters | 300 preloaded CP dissolution parameters (on-call retrieval) |
| Display & Operation | Large LCD screen with intelligent menu controls |
| Test Head Mechanism | Auto-lift with flip function (user-optimized model) |
| Temperature Monitoring | Multi-point electronic sensors |
| Standard Configuration | 8 paddles & 8 vessels |
| Optional Accessories | Small-vessel kit |
| Heating Power | 1100 W |
Advanced models feature integrated UV/Vis fiber optics, robotic sample handling, and 21 CFR Part 11-compliant software for real-time data analysis, validation, and audit trails. Applications span drug development, batch release testing, and formulation optimization, ensuring product efficacy, safety, and compliance with FDA/EMA requirements.
Robust construction, modular design, and intuitive interfaces further enhance reliability for critical laboratory workflows