Agilent Technologies Introduces Verified Dissolution Components for Pharmaceutical Market

Santa Clara, CA—May 15, 2013—Agilent Technologies Inc. (NYSE: A) today introduced a new series of verified dissolution components, including molded vessels as well as paddle and basket shafts. Designed to ensure compliance with mechanical qualification guidelines, these compo-nents will be available June 1 and offer verification that they conform to exact specifications.

Dissolution is a technique used in the pharmaceutical industry to determine the rate at which pure active pharmaceutical ingredients dissolve. To meet precise toleranc-es, the new molded vessels are vacuum formed around a set of Agilent's mandrels, which eliminates the warps and flaws of traditional hand-blown manufacturing.

"To better support the qualification needs of our customers, it was critical for Agilent to offer improved options for component verification and traceability," said Allan Little, director of marketing for dissolution systems at Agilent. "Not only do we offer these new vessels and shafts, but Agilent is leading the effort to educate pharmaceutical analysts on the importance of compliance with the developing qualification guidelines."

The verified paddle and basket shafts are being introduced to meet a growing demand for verified compo-nents. Made with updated manufacturing processes, these shafts are measured to exact specifications and certified for traceability with an individual certificate of conformance.

Qualification of dissolution apparatus in pharmaceutical laboratories involves performance verification testing, enhanced mechanical qualification, or a combination of the two procedures. With evolving guidance on qualifica-tion best practices, the adoption of verified components assists with long-term traceability and offers assurance that components meet tolerances set by the United States Pharmacopeia.

For more information, visit www.agilent.com/lifesciences/dissolution

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world's pre-mier measurement company and a technology leader in chemical analysis, life sciences, diagnostics, electronics, and communications. The company's 20,500 employees serve customers in more than 100 countries. Agilent had revenues of $6.9 billion in fiscal 2012. Information about Agilent is available at www.agilent.com

EDITORIAL CONTACT: PRCA13026
Eric Endicott
+1 408 553 2005
eric_endicott@agilent.com

Agilent Technologies Introduces Software for Performing and Analyzing Dissolution via HPLC

Santa Clara, CA—April 25, 2013—Agilent Technologies Inc. (NYSE: A) today introduced LC Dissolution Software, an add-on module for use with the ChemStation Edition of the Agilent OpenLAB Chromatography Data System. This software module simplifies the quantification and reporting of dissolution samples analyzed by HPLC, maximizing the user's investment in dissolution apparatus, liquid chromatographs, and informatics.

Once dissolution samples have been collected, they are loaded into the chromatograph and analyzed. The LC Dissolution Software module automates the setup of the chromatograph, incorporates the dissolution methodology, performs the sample analysis, and generates the final reports. Real-time views of the dissolution profiles of all active ingredients are available as the analysis progresses.

"Pharmaceutical customers can maximize their current workflow by integrating dissolution with LC analysis using LC Dissolution Software," said Allan Little, Agilent director of marketing for dissolution systems. "This software eliminates the need to export data to a spreadsheet and thus ensures the integrity and security of dissolution analysis data, all in a 21 CFR Part 11 environment."

• Easy integration of existing chromatographic methods for automatic generation of analysis sequences.
• Sequence generation independent of hardware.
• Full utilization of all Agilent LC ChemStation software capabilities.

For more information, visit www.agilent.com/lifesciences/lcdissolution

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world's pre-mier measurement company and a technology leader in chemical analysis, life sciences, diagnostics, electronics, and communications. The company's 20,500 employees serve customers in more than 100 countries. Agilent had revenues of $6.9 billion in fiscal 2012. Information about Agilent is available at www.agilent.com

EDITORIAL CONTACT: PRCA13026
Eric Endicott
+1 408 553 2005
eric_endicott@agilent.com

April 2013—SOTAX Group, an international leader in the development and manufacturing of pharmaceutical testing equipment, is pleased to announce the expan-sion of its global subsidiaries with the opening of a new office in the Czech Republic. This new subsidiary, based in Prague, will operate under SOTAX Pharmaceutical Testing s.r.o.

"The goal of expanding the SOTAX Group with the opening of the Prague office is to provide our Czech customers with more efficient access to the latest phar-maceutical testing products as well as technical support. It will allow us to offer even greater personalized service and to explore higher levels of collaboration with the local pharmaceutical community," says Thomas Pfammatter, CEO of the SOTAX Group.

The newly found subsidiary will be managed by Ing. Iva Martincova, who possesses substantial knowledge of the Czech and Slovakian pharmaceutical market. "We are excited to respond to the growing demands of our clients by estab-lishing a new presence in Eastern Europe. Iva's background and experience make her ideally suited to lead our Czech operations to ensure we remain client centric," says Ramsey Khinda, Head of Sales & Marketing (Business Unit Europe).

In Europe, SOTAX also maintains subsidiary offices in Germany, Great Britain, France, and Italy, apart from its European headquarters in Switzerland.

New SOTAX Office in Czech Republic:

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About SOTAX:

The SOTAX Group is an international leader in the development and manufacturing of pharmaceutical testing equipment. With a global network of service engineers, the company is also a trusted provider of installation, maintenance, repair, and qualification services for its SOTAX and Zymark brand products.

Good news if you use FaSSIF-V2 in your laboratory

Good news if you use FaSSIF-V2 in your laboratory— biorelevant.com has just launched SIF Powder FaSSIF-V2. As with SIF Powder Original, users simply add the powder to buffer for instant biorelevant media, but this product is specifically formulated to make FaSSIF-V2. Bastian Kloefer, product manager at biorelevant.com, explains why it has been introduced:

"An updated version of FaSSIF, known as FaSSIF-V2, was published in 2008 by Jantradit et al., and many of our customers have been requesting a SIF Powder product that makes it. SIF Powder FaSSIF-V2 has taken us quite a while to develop because we wanted to ensure that it delivers the same ease of use and high quality results as SIF Powder Original. We're very happy to launch the new product, and our customers seem really pleased with it, too."

SIF Powder FaSSIF-V2 is available in three different bottle sizes (making 250 L, 25 L, and 2.5 L FaSSIF-V2) and is priced the same as SIF Powder Original. Dissolution Technologies readers can use the exclusive promo code DTFIVEat the biorelevant.com checkout for a 5% dis-count (valid until 31 August 2013).

Introducing a Basket Mesh Evaluation Tool to Ensure Regulatory Compliance for USP Apparatus 1— ELECTROLAB EMM-01

Bridgewater, NJ—April, 2013—The ELECTROLAB Mesh Integrity Microscope-EMM-01 is a patent-pending, first-of-its-kind, basket mesh evaluation tool designed for qual-ity conscious laboratories. Because dissolution baskets tend to deform from mishandling and from the reaction of the basket mesh with acid media, they should be evalu-ated for conformance with specifications. Basket shapes or dimensions that are out of compliance with USP require-ments could alter the observed dissolution rate and cause an erroneous dissolution result.

The EMM-01 enables the analysis and micromeasure-ment of woven mesh integrity with the help of a powerful microscope with magnification up to 80', a 2M pixel CMOS sensor, and four white LEDs to provide appropriate light-ing for the basket. The EMM-01 with its intuitive software allows the user to verify in real time the cylindrical and bottom mesh of the basket to ensure its compliance with regulatory standards. The software allows measurement of the wire diameter and hole opening as well as observa-tion of any surface etching, frayed wires, rust spots, gold or PTFE coating, or residual material from a prior test. The mesh can be photographed for compliance purposes.

The calibrator slide of the EMM-01 allows the calibra-tion of the measurement software to traceable standards. ELECTROLAB recommends that the compliance of the basket mesh should be determined as frequently as the performance verification test for the equipment.

"With a greater push toward using only mechanical qualification to qualify a dissolution instrument, the EMM-01 is an essential tool for every laboratory," says Bharat Zaveri, Technical Director, ELECTROLAB who oversaw the development of the EMM-01. "The EMM-01 was devel-oped after listening to multiple scientists in laboratories worldwide, with an aim to shift from merely meeting regulatory requirements to be closer toward dissolution science."

http://www.electrolabindia.com
usa@electrolabindia.com

About ELECTROLAB

With over 8500 dissolution systems installed worldwide, ELECTROLAB is one of the leading manufacturers of pharmaceutical testing equipment. In addition to dissolution testers, ELECTRO-LAB manufacturers several types of equipment like disintegration, friability, tap density testers, etc. The company has a well-trained production team supported by in-house CAD, software, hardware design engineers, and well-established vendors to support production targets and a manage-ment that understands the importance of quality and timely delivery. This together with a flexible production process and cost effective operations has enabled it to be competitive, responsive, and reliable.

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A Video Monitoring Tool to Record the Dissolution Process on Any Brand Dissolution Tester—ELECTROLAB iDisso™-06u

Bridgewater, NJ-April, 2013—ELECTROLAB launches iDisso™-06u, a patent-pending video monitoring tool that works with all brands of dissolution testers to observe and record the dissolution process. Observation of the dissolu-tion process is especially useful during method develop-ment and formulation optimization.

The six cameras allow recording of the dissolution process in all six vessels and can be easily adjusted for height, intervessel distance, and tilt for the 1-L and 2-L vessel configurations. The intuitive software interface can be easily programmed to record video and take snapshots simultaneously. The unit can be networked for remote live viewing or later playback on any browser-enabled smart-phone, tablet, or computer. The device has over 1000 hours of continuous video recording capacity. Storage can be optimized by recording video at preprogrammed recording times and intervals. BlackOut™ is a unique optional feature that allows the conversion of any dissolution bath to test light-sensitive dosage forms with the help of amber-colored lights while observing and recording the dissolution process.

"Only chromatography results are no longer sufficient in understanding the dissolution profile of a dosage form; visual observations coupled with chromatogra-phy results help in bringing drugs to market faster," says Amit Marfatia, Managing Director, ELECTROLAB. "We understand that most laboratories have multiple suppliers for their equipment. The iDisso™-06u was developed to maximize the laboratories return on investment by ensuring compatibility across multiple suppliers."

http://www.electrolabindia.com
usa@electrolabindia.com

About ELECTROLAB

With over 8500 dissolution systems installed worldwide, ELECTROLAB is one of the leading manufacturers of pharmaceutical testing equipment. In addition to dissolution testers, ELECTRO-LAB manufacturers several types of equipment like disintegration, friability, tap density testers, etc. The company has a well-trained production team supported by in-house CAD, software, hardware design engineers, and well-established vendors to support production targets and a manage-ment that understands the importance of quality and timely delivery. This together with a flexible production process and cost effective operations has enabled it to be competitive, responsive, and reliable.

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