Huanghai

RCZ-8A Dissolution Tester – USP-Compliant Pharmaceutical Testing Equipment

Q: Which pharmacopoeia methods does this dissolution tester follow?

USP 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.

From $11,305.00 USD

Distributor & agent pricing available on request. Equipping a full QC lab? Ask about multi-unit bundle pricing.

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At a glance: RCZ-8A is an 8-vessel intelligent dissolution tester from Huanghai Pharmaceutical Instruments (Shanghai, since 1978), with the same feature set as the RCZ-12A: separate stirring system and automatic tablet dropping. It runs USP Apparatus 1 and 2 per USP <711>, ChP 0931 and Ph. Eur. 2.9.3, with 3-level user management, audit trail and USB export.

Dissolution Instruments

RCZ-8A Intelligent Pharmaceutical Dissolution Tester

The RCZ-8A Intelligent Dissolution Tester is a reliable and efficient pharmaceutical testing instrument for solid dosage dissolution. Designed for accuracy and compliance with USP guidelines, it features automated controls and real-time monitoring. This dissolution tester supports pharmaceutical R&D and production testing with repeatable performance and precise control.

Description

The RCZ-8A 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 8-channel dissolution system ensures precise testing and complete data integrity. It is compatible with the ZQY-8A 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 and sampling solutions can be stored for convenient reuse.

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

Parameter	Specification
Model	RCZ-8A
Product Number	10100110
Dissolution Channels	8 channels
Swing Radius Consistency	≤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.