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How Can Excipients Contribute to Nitrosamine Risk in Drug Products?
26
Oct
By No Comments

How Can Excipients Contribute to Nitrosamine Risk in Drug Products?

When pharmaceutical teams investigate nitrosamine risk, attention often begins with the active pharmaceutical ingredient (API) and its manufacturing process. But the API is only part of the picture. Excipients can contribute to nitrosamine risk by introducing trace nitrite or other relevant precursors into a drug product. When those precursors encounter a susceptible amine under favorable […]
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Why Sensitivity and Selectivity Matter in Pharmaceutical Nitrosamine Analysis
22
Oct
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Why Sensitivity and Selectivity Matter in Pharmaceutical Nitrosamine Analysis

Pharmaceutical nitrosamine analysis presents an unusual analytical challenge. The impurities of interest may need to be measured at extremely low concentrations, while the analytical sample can contain: a much higher concentration of active pharmaceutical ingredient (API); multiple excipients; process impurities; degradation products; solvents; and other matrix components. This creates two simultaneous requirements: Sensitivity — can […]
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How Can Excipients Contribute to Nitrosamine Risk in Drug Products?
17
Oct
By No Comments

How Can Excipients Contribute to Nitrosamine Risk in Drug Products?

When pharmaceutical teams investigate nitrosamine risk, attention often begins with the active pharmaceutical ingredient (API) and its manufacturing process. But the API is only part of the picture. Excipients can contribute to nitrosamine risk by introducing trace nitrite or other relevant precursors into a drug product. When those precursors encounter a susceptible amine under favorable […]
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Why Leachables Assessment May Need to Continue Through Pharmaceutical Stability Studies
14
Oct
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Why Leachables Assessment May Need to Continue Through Pharmaceutical Stability Studies

A container-closure system may appear chemically compatible with a drug product at the beginning of shelf life. That does not necessarily mean the leachables profile will remain unchanged months or years later. Leachables can migrate from packaging, delivery systems, manufacturing-contact materials, or other product-contact components into a pharmaceutical product over time. Their formation and accumulation […]
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Understanding Analytical Evaluation Thresholds in Extractables and Leachables Studies
13
Oct
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Understanding Analytical Evaluation Thresholds in Extractables and Leachables Studies

Extractables and leachables (E&L) studies can generate dozens—or even hundreds—of chromatographic peaks. But not every detected compound presents the same potential safety concern, and attempting to identify and quantify every analytical signal regardless of exposure would make many E&L programs unnecessarily complex. This is where the Analytical Evaluation Threshold (AET) becomes important. The AET provides […]
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9 Steps in Pharmaceutical Nitrosamine Risk Assessment
15
Sep
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9 Steps in Pharmaceutical Nitrosamine Risk Assessment

Nitrosamine risk assessment has become a critical part of pharmaceutical impurity control. Since nitrosamine impurities were first identified as a major regulatory concern in medicines, the scientific focus has expanded from well-known small-molecule nitrosamines such as NDMA and NDEA to a much broader range of potential impurities, including nitrosamine drug substance-related impurities (NDSRIs). The challenge […]
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