Press Room

Event

Webinar - Heavy Metals determination by UPLC

Start
Thursday, January 29, 2015 - 14:00
End
Thursday, January 29, 2015 - 15:00

Speakers

António Ramos

Analytical Development Group Leader 

Lúcia Volta e Sousa

PhD Student / Analytical Chemist

 

Elemental impurities analysis has a great importance within pharmaceutical realm due to its impact on the quality, safety and efficacy of drug product and substances. These impurities can include catalysts and environmental contaminants that may be present in drug substances, excipients or drug product. For that reason, it is necessary to have a rigid control, during the manufacturing process in order to assure that the final product is within the specification limits described in the USP chapter 232> and recently approved ICH Q3D guideline. There are two procedures acknowledge by USP that can be used to analyze and control these materials, as ICP-MS and ICP-AES. These techniques are expensive and most of the times are not available in every manufacturing sites. According to USP 233> acceptable alternative procedures that meet validation requirements can be used. An alternative Microwave / UPLC / UV-VIS provides a powerful, advantageous and fast solution for heavy metals determination with improvements in terms of time and costs. The breakthrough is the use of microwave based digestion to obtain a universal method that can be applied to any organic matrix. The use of a Quality by Design approach will allow for a better understanding of the method design space and a more effective method development.

Also in the Press Room

See All

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

Article
Fierce Pharma, 26 March 2026

As expansions come online, CDMO Hovione aims to meet industry's 'dual supply and sourcing' zeal: exec

Mar 26, 2026

Twenty companies presented at the annual kickoff to DCAT Week. The Drug, Chemical & Associated Technologies Association (DCAT) opened DCAT Week 2026 with its Member Company Announcement Forum. The kickoff to the annual event in New York City, underway from March 23–26, 2026, showcased 20 companies. These were selected based on their announcements’ “news priority, criticality, and interest” to DCAT member companies. The following is a summary of highlights from the presentations, supplemented by additional information provided by some of the companies. (...) Hovione Hovione’s Vice President of Technical Operations for the Americas, David Basile, delivered the company’s Member Company Announcement Forum presentation. Basile will be speaking exclusively with Contract Pharma during DCAT Week, so check back for more on Hovione’s latest.   Read the full article at ContractPharma.com    

Press Clipping
Contract Pharma, 23 March 2026

DCAT Member Company Announcement Forum 2026: An Inside Look

Mar 23, 2026

With more than six decades of experience in pharmaceutical development and manufacturing, Hovione is an international CDMO offering a comprehensive range of services for New Molecular Entities (NMEs), including drug substances, intermediates, and drug products. The company also supplies niche generic APIs and delivers advanced technologies supporting multiple drug delivery platforms, including oral, injectable, inhalation, and topical formulations.  Today, Hovione employs 2,500 people worldwide and operates 900 m3 of manufacturing capacity across four sites in Europe, the U.S. and Asia. Japan has played an important role in the company’s global strategy since its early years. Initial export activities were followed in 2017 by the establishment of a Japanese subsidiary in Osaka.   Read the full article in Japanese at Yakuji.co.jp Read the article translated in English  

Press Clipping
Yakuji Nippo Magazine, 13 March 2026

International CDMO strengthens its presence in Japan: from active pharmaceutical ingredients to formulations, all at the same location

Mar 13, 2026

Also in Events

See All