400-DS Specifications - Specification Sheet

Importance of the topic

Small‐volume dissolution testing plays a critical role in the characterization of drug release from combination medical devices. By enabling precise, reproducible measurement of active ingredients in minimal media volumes, laboratories can optimize formulations, ensure regulatory compliance and support both R&D and quality control activities.

Objectives and overview of the specification sheet

The 400-DS Dissolution Apparatus specification sheet presents the design features, performance criteria and compliance standards of Agilent’s compact system built for USP Apparatus 7 testing. The document aims to inform users of key operating parameters, hardware dimensions and regulatory approvals that underpin its suitability for small‐volume dissolution studies.

Methodology

The apparatus is engineered to conduct compendial dissolution tests under controlled conditions. Core functions include programmable reciprocation of samples, temperature regulation and automated sampling. Integrated software supports time‐point scheduling, data logging and 21 CFR Part 11–compliant audit trails.

Used Instrumentation

• Agilent 400-DS Dissolution Apparatus with built-in autosampler
• USP Apparatus 7 compliance for up to five media exchanges per test
• Software package meeting 21 CFR Part 11 requirements

Main performance characteristics and discussion

• Sample reciprocation: 20 mm ±1.0 mm travel at 1–35 dips per minute (±0.5 % rate accuracy)
• Temperature control: ambient + 5 to 55 °C with ±0.2 °C stability
• Media volume: 3–5 mL cells or 8–12 mL cells with ±1 % volume accuracy
• Sampling: up to 13 time points per test, ±2 % timing precision
• Throughput: up to 13 samples per test and up to 5 different media types
• Evaporation control: ≤0.2 % volume loss over 24 h
• Dimensions: 53.3 cm (H) × 58.4 cm (W) × 59.7 cm (D); weight 59 kg
• Regulatory certifications: EMC Directive, Machinery Directive, EN 61326-1, IEC 61010-1, CAN/CSA-C22.2, UL 61010-1

Benefits and practical applications

The 400-DS apparatus delivers enhanced bench‐space efficiency through its compact footprint and integrated autosampler. Its high precision in dip rate, temperature and volume control improves reproducibility in both R&D formulation screening and routine quality control. Compliance with international safety and electronic-record regulations simplifies validation in regulated environments.

Future trends and applications

Advances in miniaturization and real‐time analytical detection may be integrated with dissolution platforms to provide continuous online monitoring. Coupling with advanced data analytics and PAT frameworks is expected to streamline method development, reduce sample consumption and accelerate formulation optimization.

Conclusion

The Agilent 400-DS Dissolution Apparatus establishes a new benchmark for small‐volume, compendial dissolution testing. Its precise performance, regulatory compliance and space‐saving design make it an effective tool for both research laboratories and manufacturing QA/QC workflows.

Reference

• Agilent Technologies, "400-DS Dissolution Apparatus Specification Sheet", 2013, document number 5991-2120EN.