HPLC Engineers offers laboratories the pharmaceutical dissolution testing apparatus, dissolution accessories, and dissolution software for efficient and reliable dosage form testing. Extensive dissolution skills training is also offered to meet the needs of all busy laboratory analysts.

Feel confident with Agilent dissolution testing apparatuses. All systems meet the international harmonized guidance requirements defined by USP, EP, CP, IPC, and JP for effective drug dosage form testing. Laboratory analysts can efficiently meet data integrity requirements too. Working to Title 21 Code of Federal Regulations (CFR) part 11 compliance standards is readily achieved using dissolution testing software.

PRODUCT DESCRIPTION

Standard Features

The system features advanced, user-friendly Micro-Processor Control, which comply with current USP, IP and EP specifications. It has a splash-proof keyboard, moulded water bath – enabling comparative studies – together with an in-built immersion pump. The mono shaft design has easy changeover between Apparatus I & II, which eliminates outine height validation as per USP. All paddles, baskets and vessels are laser marked with serial numbers for traceability. The tablet dispenser drops 12 doses in a single instance. The conical shaped, low evaporation recovery lids reduce media loss during a long run. The integrated pre-centred lids require no manual removal or positioning, ensuring the automatic centring of vessels and precise positioning of paddle/basket without any special tool, as per Pharmacopeia requirements. The system also features easy placement and locking of vessels, allowing the vessels to simply slide into place, and once placed, the vessels do not float, even when empty. There is also the facility to monitor vessel temperature with an external RTD Temperature Sensor.

Software

PG 14000 is GLP compliant, with alphanumeric entries of sample name, sample number and identification number for authentication. It has a built-in Real Time Clock, a Daily Auto Incremented Run Number and factory entered Customer Name with instrument serial number on report printouts. It has non-volatile memory storage of 15 methods with parameters, together with validation software, validating Revolutions Per Minute, temperature, sampling volume and replenish volume. It also features user interactive software in dialogue mode for ease of operation, together with multilevel password protection for method editing (10 users). The dissolution run can be started with last run parameters, and the facility to view set parameters during run. The Auto Start facility can continue the dissolution analysis in the event

Regulatory Compliance

The new PG DS 14000 meets all requirements relating to validation, qualification and calibration. Appropriate qualification documents can be supplied with the instrument.