The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examined the European Fine Chemicals Group (EFCG) and […]
Date: November 12-14 Location: Hamburg, Germany Venue: Hamburg Congress Center Come meet with the following team members: Pedro Couto Rosado Rachel Pearce SK pharmteco has lots of news to share, including the announcement of a significant expansion of its small molecule and peptide production capabilities – a $260 million investment to construct a new state-of-the-art facility in Sejong,
2024 TIDES Europe Oligonucleotide & Peptide Therapeutics Read More »
The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examine the European Fine Chemicals Group (EFCG) and
This is the first in a series of entries examining nitrosamines in a range of products. Nitrosamines are organic compounds found in the human diet and other environmental outlets. Being potent carcinogens that can cause tumors in nearly all organs, they have been classified as genotoxic impurities (GTIs). There are guidelines and rulings by various regulatory organizations, including
Nitrosamines: An Overview Read More »
Maintaining CGMP products in qualified stability chambers is crucial for determining the expiry period and establishing the safety of your products. SK pharmteco Analytical Services offers all ICH* stability storage conditions and has experienced analytical scientists to support all of your CGMP stability requirements. We can transfer or validate your existing analytical methods to support
Stability and Storage Read More »
A special thanks to Matt Webberley, Associate Director Analytical Research and Development at our Ireland site of SK pharmteco Analytical Services, for his assistance with the profiles of AAS, ICP-OES, ICP-MS, and XRD. A Definition of These Newsmakers Elemental impurities in food have been in the news recently, with reports of everything from lead being
Elemental Impurities Read More »
Extractables and Leachables (E&L) are essential areas of concern for the pharmaceutical and food industries, specifically regarding their packaging, usage components (e.g., medical devices or syringes), and the manufacturing chain. We will examine testing of analysis of them within pharmaceutical applications. The two terms are related but distinct, each with its own analytical requirements. Definitions of
Extractables and Leachables Read More »
Dynamic Vapor Sorption (DVS) is a gravimetric technique used to measure the change in mass of a material in response to changes to surrounding conditions such as temperature or humidity. DVS is primarily used with water vapor but can be applied to other organic solvents as well for the physicochemical characterization of solids. DVS was
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Background on Chiral Purity Chirality refers to the phenomenon that occurs when a mirror image cannot be superimposed. It is sometimes called “optical rotation”. The origin is from the late 19th-century Greek word kheir (‘hand’) and is one of the easiest demonstrations of the concept. Although a person’s hands may appear virtually identical, if they were switched, the
Chiral Purity Analysis – The Need to Know What Both Hands Are Doing Read More »
The term Reference Standard Qualifications (RSQ) “is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria,”1 and incorporate these quantitative reference standards to do so: purity, potency, identification, impurities content, and generally full characterization. Identity Testing There are a range of tests to ensure the identity of the drug product or drug substance.
Setting the Standard with Reference Standard Qualifications Read More »
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