Displaying 1–25 of 309 results for USP

Sort By Relevance Sort By Date
1 2 3 4 5 ...13

USP Updates and for Microbial Testing of Non-Steriles

(Article)

The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts

USP Tests to be Updated

(Article)

Emil Ciurczak talks with Bill Cook, Chief Metrology Officer, and Darrell Abernethy, Chief Science Officer, USP

USP's DeStefano on Defining, and Detecting, Pharmaceutical Impurities

(Article)

Economically-motivated adulteration is one of many issues that industry, and USP, is tackling

Inside USP’s New Pharmaceutical Ingredient Verification Program

(Article)

The U.S. Pharmacopeia's program is designed to assure manufacturers, regulatory authorities and consumers that drug substances and excipients bearing the “USP Program Mark” are of consistent, high quality.

USP's Gary Ritchie with an Update on PAT Standards Development

(Article)

Emil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP. Listen to the interview or read the transcript here.

USP CEO Roger L. Williams, M.D., to Step Down in 2014

(News)

USP Board of Trustees initiates transition process of CEO Roger L. Williams in accordance with previously agreed contractual commitments

Thermo Scientific Handheld Instruments Chosen for USP Project

(News)

USP will use Thermo Scientific TruScan RM and microPHAZIR RX instruments to develop raman and NIR libraries for pharmaceutical manufacturers

Tales from the Counterfeiting Front: USP’s Drug Quality Matrix

(Whitepaper)

USP has released an updated version of its matrix tracking public reports of counterfeit and substandard drugs worldwide. The report is more anecdotal than comprehensive—there’s no way to chronicle all incidents—but tells a vivid story of the challenges facing local authorities worldwide in ...

Measuring Samples Per USP 26 Using Shimadzu TOC-VW

(Whitepaper)

The United States Pharmacopoeia has established guidelines for determining system suitability and established the acceptance of Water For Injection (WFI) purposes and Purified Water (PW) (USP Revision 26 method <643>). Shimadzu’s TOC-VW analyzer is adapted to meet the requirements of USP Rev. 26 ...

Anticounterfeiting the Focus of USP Science Meeting

(Article)

At the USP Science Meeting in Toronto last week, the topic of anticounterfeiting and assuring drug quality took center stage. A number of presentations addressed the use of analytical technologies to protect public health. Raman spectroscopy appears to be gaining use to help detect fakes in the ...

One-Third of Antimalarial Medicines Sampled in Three African Nations Found to...

(News)

The first results from a large-scale study of key antimalarial medicines in ten Sub-Saharan African countries reveal that a high percentage of medicines circulating on national markets are of substandard quality and thus may contribute to the growth of drug-resistant strains of Plasmodium ...

USP Re-evaluates Dissolution Test Tablets, Methods

(News)

USP has re-evaluated the currently available Prednisone RS Tablets Lot P0E203 and established new acceptance criteria based on a whole-assembly geometric mean and standard deviation approach rather than the individual-position (per tablet) approach.

Strategic Cold Chain Management: USP, EC and Evolving Regulations

(Whitepaper)

eBook on meeting USP and EU GDP regulatory requirements. Learn the latest revisions from the U.S. Pharmacopeial Convention (USP) Good Distribution Practices (GDP) according to the European Commission.

Focus on Pharma Episode 20: FDA and USP Collaborate to Update Standards for ...

(Multimedia)

A September workshop sponsored by FDA and USP will examine progress in modernizing analytical methods and test procedures, to help prevent adulterated over-the-counter medications from reaching the public. Impurities testing and material identification will be critical. Both Agencies summarized ...

New USP Sterile Water Testing Requirements

(Whitepaper)

On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to ...

Analyzing for Elemental Impurities

(Article)

Understanding new guidance from the USP so that you can determine which approach to adopt when performing elemental impurity analysis.

USP Microbial Examination of Non-Sterile Products

(Article)

A road map to the world of non-sterile testing regulations

Residual Solvents by HT3 Headspace in Reference to USP 467

(Whitepaper)

Residual solvents in pharmaceuticals are defined as volatile organic chemicals that are used or produced in the manufacture of drug substances, excipients or in the preparation of drug products. Because residual solvents do not provide therapeutic benefits, they should be removed, to the extent ...

USP Updates and for Microbial Testing of Non-Steriles

(Article)

Significant changes include more clarity on enumberation and specified organisms

Tracking Substandard Medicines; USP, FDA to Evaluate OTC Drugs

(Article)

The PQM program has launched a new public database of medicines collected and analyzed.

USP India’s New Facility Opens its Doors

(Article)

AstraZeneca India's former president oversees the operation, which includes a business office and testing laboratories.

Will USP and FDA Reach Consensus on Stability Testing?

(Article)

Editor in Chief Agnes Shanley observes that standards will guide drug manufacturing's future, if everyone can agree on what's important.

USP Presents Heparin Quality Standards

(Article)

Small but necessary steps towards new and improved standards

PAT in Perspective: Do We Need Final Release Tests with PAT?

(Article)

NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests…and concludes that they’re still essential as a reference method and important in minimizing liability.

Stopping Counterfeits and Substandard Drugs

(Article)

An interview with Patrick Lukulay, Director of USP’s Drug Quality and Information Program, a grant-funded program funded by US AID with the goal of strengthening QA and QC in developing countries. The program is now working in Africa, Latin America and Southeast Asia.

Sort By Relevance Sort By Date
1 2 3 4 5 ...13