Dissolution and Drug Release Testing DISSOLUTION SYSTEMS SOURCE BOOK 2011-2012 Edition Agilent Technologies

Welcome Agilent Technologies, Inc. is well known within the pharmaceutical community for its broad portfolio of instruments and supplies, and now offers a variety of dissolution and pharmaceutical testing equipment. Agilent’s unique position as a leader in analytical instruments allows us to meet all your needs for equipment, software and reporting packages, qualification documentation and services, training and post-sale support – anywhere you operate around the globe. The latest edition of the Dissolution Source Book provides a detailed view of this portfolio, including dissolution apparatus,...

Market Solutions Market Solutions Agilent Solutions for the Pharmaceutical Industry About Agilent Agilent Technologies is the world’s premier measurement company. Through the company’s acquisition of Varian, Inc. in 2010, we expanded our already extensive product portfolio for the pharmaceutical industry. The former VanKel Technology Group, which Varian acquired in 2001, offered many instruments for testing and evaluating pharmaceutical dosage forms including dissolution, disintegration, friability, hardness and tapped density. These products and accessories are now fully integrated in the worldwide...

Market Solutions Workflow Enhancements We strive to provide solutions for every type of dissolution user, from routine applications to early drug development. Our equipment is designed to be easy to use, flexible and modular in nature. As the workload increases, we offer greater degrees of automation, both in the dissolution test run and sample collection as well as the data analysis and reporting. Purchasing a dissolution system from Agilent ensures you have one vendor to turn to should you have questions or require assistance, so you have less downtime and better utilization of your equipment....

Industry Information Industry Information Apparatus, Pharmacopeia and Regulatory Affairs Overview The design of dissolution apparatus is specified by the various pharmacopeias from around the world. In addition, both the FDA and ASTM have called for tighter mechanical specifications. The apparatus is routinely operated in facilities regulated by federal agencies, such as the US Food and Drug Administration, which require laboratories to operate under good manufacturing practices (GMPs). Agilent’s dissolution apparatus are developed to operate under GMP environments which require installation,...

Industry Information Applications and Testing Capabilities of Agilent Dissolution Apparatus Dissolution Apparatus Description Common Products Types Stirred Vessel Methods - The basket and paddle dissolution apparatus are the most commonly used throughout the world. These methods traditionally require the placement of individual dosage forms into 1L glass vessels containing a fixed volume of fluid referred to as dissolution medium. Rotating Basket Shaft with attached mesh basket fabricated from 316 stainless steel; the dosage form is contained within the basket, lowered into media 1 Floating dosage...

Dissolution Apparatus and Accessories Apparatus 1, 2, 5, 6 and Intrinsic Agilent 708-DS Dissolution Apparatus The 708-DS Dissolution Apparatus provides an ideal platform for laboratories to standardize their dissolution testing. This instrument is designed to deliver consistent performance and results while conforming to current internationally harmonized pharmacopeial specifications for basket, paddle, rotating cylinder, paddle over disk and intrinsic dissolution tests. The instrument’s versatile dissolution platform is capable of drug performance testing under the most demanding laboratory...

Dissolution Apparatus and Accessories Designed with Compliance in Mind The recessed head with unobstructed access on the 708-DS makes setting and verifying physical parameters easier than ever, which is especially critical for Mechanical Qualification. Agilent has not only raised the standard for dissolution instrumentation with the 708-DS, but has made available a fully enhanced laboratory solution. This includes the traditional AIQ compliance services and documentation consisting of IQ, OQ, PQ and/or MQ. In addition to these traditional offerings, Agilent provides training and familiarization,...

Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus Bundles Bundles are available for the most common 708-DS configurations, and include a standard 708-DS with specified features, accessory kits, 1L TruAlign clear vessels and receptor shafts. Paddle shafts, basket shafts and baskets must be ordered separately. In addition to the 708-DS bundles, a custom configuration gives you the flexibility to choose additional options to support your testing needs. • 6- or 8-position apparatus and accessory kits • DDM option to automate dosage delivery • Sampling option via an automated manifold...

Dissolution Apparatus and Accessories Non-resident sampling cannulas in a TruAlign vessel on To configure a custom 708-DS, select an option from each of the subsections in the Custom Configurations table on the following pages. See the example below for a 6-position, 2L 708-DS with vessels, motorized lift, Autosampling option, AutoTemp option, DDM option, printer, baskets and paddles. 708-DS Custom Configuration Ordering Example Quantity Description 708-DS/709-DS thermal printer assembly 708-DS assembly, common accessories, 1 and 2L, 6-position Upper receptor shaft, 21 in. Paddle, lower interchangeable,...

Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus - Custom Configurations Part Number 708-DS Dissolution Apparatus - Base Unit Choose one (1) 708-DS base unit from this section 708-DS, 1 L, manual lift, for DDM and sampling 708-DS, 1 L, manual lift, without DDM and sampling 708-DS, 1 L, motorized lift, for DDM and sampling 708-DS, 1 L, motorized lift, without DDM and sampling 708-DS, 2L, manual lift, for DDM and sampling 708-DS, 2L, manual lift, without DDM and sampling 708-DS, 2L, motorized lift, without DDM and sampling 708-DS Dissolution Apparatus - Printer Option Choose one...