March 12th 2025
Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.
February 17th 2025
Removal of Particles by Ultrafiltration Systems
May 1st 2005Pure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.
X-ray Microtomography of Solid Dosage Forms
April 2nd 2005X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage.This article describes the basic principles of the technique and provides examples of its potential applications.
Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
April 2nd 2005The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
April 2nd 2005An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.
Establishing Target Fills for Semisolid and Liquid Dosage Forms
April 2nd 2005To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.
X-ray Microtomography of Solid Dosage Forms
April 1st 2005X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.
Establishing Target Fills for Semisolid and Liquid Dosage Forms
April 1st 2005To meet the requirements of the USP ?755? Minimum Fill and ?698? Deliverable Volume tests, target fill levels greater than 100% must be established. This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.
Appraisal of the Laser Diffraction Particle-Sizing Technique
March 2nd 2005Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.