Displaying 1–18 of 18 results for USP

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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.

Exploring Advances in Conductivity Technology

(Whitepaper)

This executive summary from GE Analytical Instruments discusses an advancement in Conductivity analysis technology that can significantly reduce the time spent to comply with the USP <645> regulation.

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 ...

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

Thermo Scientific TruScan Fast, Cost-Effective Method Development

(Whitepaper)

Thermo Scientific TruScan is a rugged, handheld system for rapid material verification. On-the-spot results are delivered in seconds with nondestructive point-and shoot sampling through sealed packaging. TruScan reduces the need for quarantine areas and staging of raw materials, while minimizing ...

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 ...

Fact or Fiction: Automated Dissolution Testing Reduces Operator Error and ...

(Whitepaper)

While the automation of dissolution testing is primarily touted as a means to reduce operator bench time, the reduction in operator error is often overlooked. In fact, many pessimists argue that the calibration and service hours associated with automation negate the overall reduction in operator ...

USP Acceptable TOC Levels for Pharmaceutical Water: How to Achieve Them?

(Whitepaper)

Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the pharmaceutical industry must develop economical and competitive production and cleaning methods,...

USP acceptable TOC levels for pharmaceutical water: How to achieve them?

(Whitepaper)

Compliance with acceptable TOC levels in pharmaceutical water regulations must be maintained within the pharmaceutical industry throughout different manufacturing processes. This white paper attempts to classify these necessary regulations and compliance through preparation, production and waste ...

ANATEL TOC600 Online Total Organic Carbon Analyzer

(Whitepaper)

ANATEL TOC analyzers are the industry standard for purified water and ultrapure water. The ANATEL TOC600 provides online TOC analysis for a range of applications requiring USP Chapter <643> and EP Chapter 2.2.44 for TOC requirements, as well as USP Chapter <645> for conductivity measurement. The ...

ANATEL PAT700

(Whitepaper)

The ANATEL PAT700 is a science and risk-based on-line TOC analyzer that simplifies the application of process analytical technology in life science water system applications. Designed as a fully compliant TOC analyzer that meets the requirements of USP <643> and EP 2.2.44 for TOC, USP <645> and ...

ANATEL A643a Total Organic Carbon (TOC) Analyzer

(Whitepaper)

The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring. Designed specifically to meet the needs of the pharmaceutical market, the ANATEL A643a is fully compliant with industry methods including USP<643> and <645>, EP 2.2.44 and JP XV<60>. With a number of key...

HIAC 9705 Liquid Particle Counting System

(Whitepaper)

HIAC quality and reliability take new shape in the 9705, with exciting developments in liquid particle sampling technology. An innovative sampling process, housed within the 9705’s streamlined case, provides consistent dispersion and highly pure sampling. The 9705 sets new standards for accuracy ...

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 ...

Particle Counting in Injectable Solutions

(Whitepaper)

This paper, by Particle Measuring Systems, in its third revision, discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that ...

Benefits of Adopting Rapid Microbial Methods

(Whitepaper)

It's no secret that Rapid Microbial Methods (RMM) can save pharmaceutical manufacturers time and money, yet widespread adoption of these technologies remains slow due to perceived regulatory hurdles.

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