RCZ-12A Intelligent Pharmaceutical Dissolution Tester - Advanced Drug Dissolution Testing

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.

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

l   Model    RCZ-12A

l   Product Number 10100109

l   Dissolution Channels  12 channels

l   Swing Radius Accuracy    ≤0.5mm

l   Rotation Speed Deviation ≤1.0mm

l   Axial Deviation   ≤1.0mm

l   Speed Range      10–300 RPM

l   Stability ≤1%

l   Adjustment Range     Room temperature to 45.0°C

l   Temperature Uniformity     0.1°C

l   Control Precision ±0.3°C

l   Sampling Volume       <100ml

l   Sampling Time     ≤999.9h/59min59s

l   Power Supply       AC220V±10%, 50Hz

Note: Our lab instruments support basic audit trails strictly per USP/ChP standards.

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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 ±0.5°C 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 your batch size and testing throughput. A 6-channel tester (RCZ-6N) suits small-volume labs running one formulation at a time. An 8-channel tester (RCZ-8A) accommodates USP <711> 6-vessel runs with 2 spares. A 12-channel tester (RCZ-12A) is ideal for high-throughput labs running two products simultaneously. As a rule: choose at minimum 8 channels for routine QC; upgrade to 12 if you have more than 3 active products in QC testing. Contact us for pricing.

Q: What is the difference between syringe pump and peristaltic pump in automated sampling?

A: Syringe pumps (used in Huanghai RCZ-QY series) deliver precise, pulsation-free sample withdrawal—critical for viscous media or flow-sensitive APIs. Peristaltic pumps are lower cost but introduce pulsation artifacts that can affect UV absorbance readings in inline detection. For validated methods submitted to regulatory agencies, syringe-pump systems such as the RCZ-QY12 are preferred because they demonstrate superior reproducibility in audit-trail-backed data.

Q: Does the dissolution tester support FDA 21 CFR Part 11 compliance?

A: Huanghai intelligent dissolution testers (RCZ-8N, RCZ-12A, RCZ-QY series) include audit trail functionality—timestamped records of all parameter changes and operator actions—meeting basic USP and ChP audit trail requirements. However, they are not certified as fully 21 CFR Part 11 compliant because certain parameters remain modifiable for R&D flexibility. For FDA-regulated QC environments, pair the instrument with a validated LIMS or laboratory software stack to achieve full Part 11 compliance. Contact us to discuss compliance configuration for your specific regulatory submission.

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 in a single cycle using vacuum + UV sterilization, eliminating microbial contamination risk. For labs running 8–12 channel testers, a dedicated degasser prevents throughput bottlenecks between runs.