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The Principles of Green Chemistry – First Principle: Prevent Waste 

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Our latest blog series is designed to guide readers towards a greener, more sustainable laboratory [environment]. In 1998, Paul Anastas and John Warner defined the 12 principles of Green Chemistry in their book, Green Chemistry: Theory and Practice.1 Yale Professor Paul Anastas, also known as the “father of Green Chemistry,” defined the specific tenets required to […]

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SK pharmteco’s Swords Facility Celebrates 60 Years of Pharmaceutical Excellence

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Swords, Ireland – [August 26, 2024] – SK pharmteco’s Swords facility celebrated its 60th anniversary on August 8th, marking six decades of pharmaceutical manufacturing excellence. Since its establishment in 1964, the facility has grown into a global leader in the development and production of critical active pharmaceutical ingredients (APIs).  “It is an honor to commemorate

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2025 and Beyond: A Look at Upcoming NDSRI Regulations 

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The presence of nitrosamine drug substance-related impurities (NDSRIs) in medications has become an urgent issue for the pharmaceutical industry.  In response, the FDA issued critical new guidance in August 2023, setting strict acceptable intake limits (AIs) for NDSRIs. While some deadlines have already lapsed, an imminent deadline looms: August 1, 2025. By this date, manufacturers

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An Open Letter From Our CEO, Joerg Ahlgrimm to SK pharmteco Customers

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SK pharmteco’s mission is to improve patient outcomes and save lives by partnering with our customers to produce and deliver life-changing therapies through manufacturing and technical excellence, a positive and adaptable workforce, and an intense focus on safety, quality, and innovation. Our goal is to ensure the success of you, our customer, and partner. We

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Nitrosamines: An Overview

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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

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Stability and Storage

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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

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Elemental Impurities

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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

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Extractables and Leachables

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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

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Raw Materials Testing: Trust – and Verify – Your Sources

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The CGMP guidance for APIs from the FDA states that raw material specifications should be established and documented. The guide’s key line states, “Quality measures should include a system for testing raw materials, packaging materials, intermediates, and APIs. (19.23)”1  All raw materials used in producing APIs for clinical trials must be evaluated by testing or received from

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The Background, Advantages of, and Considerations for Radiolabeled Peptides

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Integrin αvβ3 and RGD Binding The use of radiolabeled peptides is a well-established tool in researching and treating many diseases and conditions. Selective receptor-targeting peptides are utilized as agents due to their rapid circulatory and tissue clearance and the high affinity and specificity to their targets. Peptides also have a relatively small size and low

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