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Huanghai
RCZ-12A Intelligent Pharmaceutical Dissolution Tester - Advanced Drug Dissolution Testing
RCZ-12A Intelligent Pharmaceutical Dissolution Tester - Advanced Drug Dissolution Testing
Distributor & agent pricing available on request. Equipping a full QC lab? Ask about multi-unit bundle pricing.
Sale Sold outAt a glance: RCZ-12A is a 12-vessel intelligent dissolution tester from Huanghai Pharmaceutical Instruments (Shanghai, since 1978) with a separate stirring system and automatic tablet dropping. It runs USP Apparatus 1 (basket) and 2 (paddle) per USP <711>, ChP 0931 and Ph. Eur. 2.9.3, with 3-level user management, audit trail and USB data export.
Dissolution Instruments
RCZ-12A Intelligent Pharmaceutical Dissolution Tester
The RCZ-12A is a high-throughput pharmaceutical testing instrument designed for large-scale dissolution testing. With capacity for up to 12 vessels, it supports efficient testing in pharmaceutical manufacturing and research labs. This dissolution tester is USP-compliant and ideal for batch testing and quality assurance.
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Description
The RCZ-12A Intelligent Pharmaceutical Dissolution Tester is designed in full compliance with the latest Chinese Pharmacopoeia and United States Pharmacopeia standards, as well as the Mechanical Validation Guidelines for Dissolution Testers. This advanced 12-channel dissolution system ensures high precision and complete data integrity. It is compatible with the ZQY-12A automatic sampling system for seamless operation.
Product Features
1. Advanced Data Management
• Built-in three-tier user permissions, audit trails, and test record management.
• USB connectivity supports direct test data export for reporting.
• Frequently used data storage for quick and easy access.
• Sampling solutions can be saved and reused conveniently.
2. High-Precision Dissolution Control
• Real-time temperature control with independent measurements for each dissolution cup.
• Dual-layer temperature protection ensures stability and reliability.
• Preheating functionality allows users to schedule start times for heating.
3. Automated and Modular Design
• Supports both manual and automatic drug addition and sampling.
• Modular design for sampling components enables quick replacement.
4. Optimized Sampling System
• Separate sampling and tray systems avoid cross-contamination.
• Vapor condensation design minimizes evaporation loss.
• Advanced circulation pipeline with professional quick-release connectors.
5. Compliance and Certification
• Fully compliant with pharmacopoeia standards.
• Includes IQ/OQ certification documentation for validation.
Product Specifications
| Model | RCZ-12A |
|---|---|
| Product Number | 10100109 |
| Dissolution Channels | 12 channels |
| Swing Radius Accuracy | ≤0.5mm |
| Rotation Speed Deviation | ≤1.0mm |
| Axial Deviation | ≤1.0mm |
| Speed Range | 10–300 RPM |
| Stability | ≤1% |
| Adjustment Range | Room temperature to 45.0°C |
| Temperature Uniformity | 0.1°C |
| Control Precision | ±0.3°C |
| Sampling Volume | <100ml |
| Sampling Time | ≤999.9h/59min59s |
| Power Supply | AC220V±10%, 50Hz |
Note: Our lab instruments support basic audit trails strictly per USP/ChP standards.
Frequently Asked Questions
Which pharmacopoeia methods does this dissolution tester follow?
USP <711> Apparatus 1 (basket) and Apparatus 2 (paddle), ChP 0931 and Ph. Eur. 2.9.3. The 10–300 RPM speed range covers the usual 50 RPM paddle and 100 RPM basket settings.
How many vessels does a QC lab need?
USP <711> tests 6 units per stage, so 6 vessels (RCZ-6N) run a full stage at once. 8 vessels (RCZ-8N, RCZ-8A) leave room for blanks or a reference, and 12 vessels (RCZ-12A) suit labs testing several products every day.
Does it support data-integrity requirements?
Yes. It has 3-level user management (Admin / Power User / User), an audit trail recording operator, date-time and event type, test data query, USB export and RS232 printing. It is designed with features that support a 21 CFR Part 11 workflow.
What options are available for light-sensitive drugs and automation?
Amber glass vessels of the same 1,000 ml size can replace clear vessels for photosensitive APIs. For automated multi-point sampling, RCZ-QY8 is supplied with RCZ-8A and RCZ-QY12 with RCZ-12A.
This Dissolution Tester is CE certified under two EU directives:
- Machinery Directive 2006/42/EC — EN ISO 12100:2010 · EN 60204-1:2018 · EN 61010-1:2010+A1:2019
- EMC Directive 2014/30/EU — EN IEC 61326-1:2021
Related: how to calibrate a dissolution tester, step by step, in our dissolution tester calibration guide.
