small molecules

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

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

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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Elemental Impurities

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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Raw Materials Testing: Trust – and Verify – Your Sources

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

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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