RCZ-1B Dissolution Tester – Pharmaceutical Testing Instrument for Tablets

Dissolution Instruments

RCZ-1B Dissolution Tester

The RCZ-1B is a high-precision pharmaceutical testing instrument ideal for dissolution testing of tablets and capsules. This dissolution tester meets USP standards and is widely used in pharmaceutical quality control labs. As part of our range of pharmaceutical testing instruments, the RCZ-1B ensures consistent, accurate results for drug dissolution studies.

Description

The RCZ-1B Single-Channel Dissolution Tester is fully compliant with the latest Chinese Pharmacopoeia and United States Pharmacopeia standards, as well as the Mechanical Validation Guidelines for Dissolution Testers. It is designed for a variety of standardized dissolution tests.

 

Product Features

 

1. User-Friendly Interface

   •  Equipped with a touch-screen human-machine interface for ease of operation.

   •  Supports bilingual (Chinese and English) interface to meet diverse user needs.

 

2. Advanced Data Management

   •  USB connectivity for test data export and report generation.

 

3. High-Precision Dissolution Control

   •  Real-time temperature monitoring with dual-layer temperature protection and calibration functionality.

   •  Independent temperature control ensures accuracy and stability.

 

4. Automated and Modular Design

   •  Modular sampling system enables quick replacement.

   •  Supports automated centering of dissolution cups and paddles.

 

5. Compliance and Certification

   •  Fully compliant with pharmacopoeia standards.

   •  Includes IQ/OQ certification documentation.

 

Product Specifications

l   Parameter    Specification

l   Model    RCZ-1B

l   Product Number 10100111

l   Dissolution Channels  1 channel

l   Swing Radius Consistency ≤0.5mm

l   Rotation Speed Deviation ≤1.0mm

l   Axial Deviation   ≤2.0mm

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 Cycle  ≤15 cycles

l   Sampling Time     ≤9999 minutes

l   Power Supply       AC220V±10%, 50Hz

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📄 Download User Manual

You can download the full user manual of the RCZ-1B Tablet Hardness Tester below:

📥 Click here to download RCZ-1B User Manual (PDF)

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.