Displaying 1–25 of 309 results for USP
The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts
Emil Ciurczak talks with Bill Cook, Chief Metrology Officer, and Darrell Abernethy, Chief Science Officer, USP
Economically-motivated adulteration is one of many issues that industry, and USP, is tackling
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.
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 Board of Trustees initiates transition process of CEO Roger L. Williams in accordance with previously agreed contractual commitments
USP will use Thermo Scientific TruScan RM and microPHAZIR RX instruments to develop raman and NIR libraries for pharmaceutical manufacturers
USP has released an updated version of its matrix tracking public reports of counterfeit and substandard drugs worldwide. The report is more anecdotal than comprehensivetheres no way to chronicle all incidentsbut tells a vivid story of the challenges facing local authorities worldwide in ...
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>). Shimadzus TOC-VW analyzer is adapted to meet the requirements of USP Rev. 26 ...
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 ...
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 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.
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.
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 ...
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 ...
Understanding new guidance from the USP so that you can determine which approach to adopt when performing elemental impurity analysis.
A road map to the world of non-sterile testing regulations
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 ...
Significant changes include more clarity on enumberation and specified organisms
The PQM program has launched a new public database of medicines collected and analyzed.
AstraZeneca India's former president oversees the operation, which includes a business office and testing laboratories.
Editor in Chief Agnes Shanley observes that standards will guide drug manufacturing's future, if everyone can agree on what's important.
Small but necessary steps towards new and improved standards
NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests and concludes that theyre still essential as a reference method and important in minimizing liability.
An interview with Patrick Lukulay, Director of USPs 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.