RCZ-8N Intelligent Dissolution Tester – Advanced Tablet Dissolution Testing Instrument

RCZ-8N Intelligent Dissolution Tester — 8-Channel

The RCZ-8N Intelligent Dissolution Tester delivers 8-channel simultaneous dissolution testing for tablets and capsules, compliant with USP <711> (Apparatus 1 basket / Apparatus 2 paddle), ChP 0931, and Ph.Eur. 2.9.3. It features built-in three-tier user permissions, timestamped audit trails, and USB data export — meeting the FDA data integrity (ALCOA+) principles required in regulated GMP laboratory environments.

Designed for pharmaceutical QC labs that run multiple formulations simultaneously, the RCZ-8N's simultaneous dosing mechanism and vapor condensation design reduce operator intervention and minimize evaporation loss across all 8 channels.

Product Features

1. Pharmacopoeia-Compliant Dissolution Method

• Fully compliant with USP <711> paddle (Apparatus 2) and basket (Apparatus 1) methods
• Compliant with ChP 0931 and Ph.Eur. 2.9.3 dissolution testing requirements
• Compliant with the Mechanical Validation Guidelines for Dissolution Testers
• Simultaneous dosing across all 8 channels — single operator action, synchronized start

2. Advanced Data Integrity & Audit Trail

• Built-in three-tier user permissions (administrator / supervisor / operator)
• Timestamped audit trail of all parameter changes and operator actions, meeting FDA data integrity (ALCOA+) principles
• USB connectivity for direct test data export to external systems or LIMS
• Frequently-used sampling solutions can be stored for efficient protocol reuse

3. High-Precision Temperature Control

• Temperature adjustment range: Room temperature to 45.0°C
• Temperature uniformity: 0.1°C
• Control precision: ±0.3°C
• Dual-layer temperature protection with real-time monitoring and calibration
• Preheating function — schedule start time to have media at target temperature before shift begins

4. Optimized Sampling System

• Speed range: 10–300 RPM with stability ≤1%
• Swing radius consistency: ≤0.5mm (meets USP mechanical suitability)
• Vapor condensation design minimizes evaporation loss during extended runs
• Advanced circulation pipeline with professional quick-release connectors for fast media changeover
• Supports both manual and automatic drug addition

5. Validation Documentation

• Includes IQ/OQ documentation templates for qualification at your facility
• Optional mini-paddle accessories available for small-volume dissolution tests

Technical Specifications

Parameter	Specification
Model	RCZ-8N
Dissolution Channels	8 channels
Speed Range	10–300 RPM
Speed Stability	≤1%
Swing Radius Consistency	≤0.5mm
Axial Deviation	≤1.0mm
Temperature 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
Weight	118 kg
Shipping Box	Main: 84×72×78 cm / 88 kg
Accessory Box	70×54×47 cm / 30 kg

---

Download User Manual

Click here to download RCZ-8N User Manual (PDF)

Note: Our lab instruments support basic audit trails strictly per USP/ChP standards, supporting FDA data integrity (ALCOA+) principles.

---

Frequently Asked Questions

Q: What pharmacopoeial standard governs dissolution testing?

A: Dissolution testing is governed by USP <711> (United States Pharmacopeia), ChP 0931 (Chinese Pharmacopoeia), and Ph.Eur. 2.9.3 (European Pharmacopoeia). All Huanghai RCZ-series dissolution testers are designed to comply with USP <711> paddle and basket methods, meeting the ±0.5 rpm speed tolerance and temperature control requirements. For international market access, verify which pharmacopoeia your target regulatory body recognizes.

Q: How many dissolution channels do I need for a QC lab?

A: Channel selection depends on batch size and testing throughput. A 6-channel tester (RCZ-6N) suits small-volume labs running one formulation at a time. The 8-channel RCZ-8N accommodates USP <711> 6-vessel runs with 2 spares — the standard configuration for routine QC. A 12-channel tester (RCZ-12A) is ideal for high-throughput labs running two products simultaneously. Contact us for pricing.

Q: Does the RCZ-8N support data integrity requirements for GMP labs?

A: Yes. The RCZ-8N includes built-in audit trail functionality — timestamped records of all parameter changes and operator actions — supporting FDA data integrity (ALCOA+) principles and basic USP/ChP audit trail requirements. For regulated QC environments, pair the instrument with a validated LIMS to complete your data integrity architecture. Contact us to discuss configuration for your regulatory requirements.

Q: What is the difference between the RCZ-8N and RCZ-8A dissolution testers?

A: Both are 8-channel intelligent dissolution testers compliant with USP <711>. The RCZ-8A is the higher-specification model and supports connection to the RCZ-QY8 automated sampling system for fully automated sample collection. The RCZ-8N features simultaneous dosing across all 8 channels and is the recommended entry point for regulated QC labs requiring 8-channel capacity with full audit trail. Contact us for a comparison.

Q: How often should dissolution media be degassed before testing?

A: USP <711> recommends degassing dissolution media immediately before use to remove dissolved oxygen that can cause bubble formation on tablet surfaces — leading to false-low dissolution results. Best practice: degas each media batch within 30 minutes of testing. The HTQ-1A Vacuum Degasser processes up to 25 liters per cycle using vacuum plus UV sterilization, preventing microbial contamination. For labs running 8-channel testers, a dedicated degasser prevents throughput bottlenecks between runs.