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Informational content on analytical services, cell and gene therapy, and small molecule topics.

Keys To Effective Method Development

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Effective method development is crucial for the quality control of Active Pharmaceutical Ingredients (API) and Drug Products (DP). Thorough method development enables successful downstream method validation.  The regulatory guidance  specifies that:  Method development and validation vary by application (quantitative, qualitative, etc.).  It is phase appropriate.  The client may provide additional guidance/validation criteria.  The validation guidance […]

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Chiral Purity Analysis – Know What Both Hands Are Doing

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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

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Shedding Light on Photo-Stability Forced Degradation

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Forced Degradation is the testing of a drug product or drug substance using situations more taxing than those if conditions were simply accelerated. This type of stability testing is designed to demonstrate various degradation pathways within the product or substance and assists with developing the product itself and its packaging. Within forced degradation testing, a

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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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Nitrosamines: An Overview

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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 the FDA, EPA, EMA, and the IARC (International Agency for Research on Cancer).

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