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Characterizing Pharmaceuticals Utilizing Chemical Imaging

July 26, 2011 Chemical imaging is an analytical technique that combines digital imaging with spectroscopy to characterize materials in various drug delivery systems, including nasal spray and inhalation products, semi-solids, solids, transdermal and controlled release systems, as well as medical devices. From determining a polymorphic form to evaluating the particle size distribution of an active

Case Studies in Foreign Particulate Analysis

Authors & ContributorsDavid Exline July 01, 2015 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Highlighted Topics An

Case Studies in Foreign Particulate Analysis Using Manual Testing Methods

April 27, 2016 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Case Studies in Foreign Particulate Analysis will

Using Raman Spectroscopy and LIBS for Automated Particle Identification

Authors & ContributorsDavid Exline July 01, 2015 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. Highlighted Topics

Proactive vs. Reactive Testing for Glass Delamination in Pharmaceuticals

Authors & Contributors Emily Landsperger February 16, 2016 Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the

Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated

Authors & ContributorsCara Plese July 27, 2016 Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is

In-depth characterizations of OINDPs from R&D to regulatory submission

October 15, 2015 Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive

Challenges in Counting and Sizing Glass Lamellae using an Automated Method

Authors & ContributorsRebekah ByrneDavid ExlineNovember 18, 2015 Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers.  By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known