Impurities
Assessing Immunogenicity Risk of Peptides
Immunogenicity risk assessment is crucial in developing highly purified synthetic peptide drug products, especially when referencing recombinant DNA (rDNA)-origin biologics. The FDA’s Synthetic Peptide Guidance and Product-Specific Guidances (PSGs) provide a structured approach to evaluating these risks and ensuring generic peptide safety and efficacy. Key Takeaways from the Guidance & ... Read More
Impurity Specification Across Different Regulatory Bodies
Impurities in pharmaceutical products play a critical role in ensuring drug quality, safety, and efficacy. Regulatory bodies such as the USFDA, EMA, PMDA, and others have specific guidelines for identifying, quantifying, and controlling impurities. Types of Impurities Key Guidelines for Impurity Control USFDA EMA PMDA (Japan) WHO Indian Pharmacopeia Differences ... Read More
Justification for Control of Elemental Impurities in Formulation
Introduction Definition: Elemental impurities are trace levels of metals that can be introduced into drug products from raw materials, manufacturing processes, or container closure systems. Regulatory requirement: ICH Q3D and relevant pharmacopeial guidelines (USP <232>, <233>) specify acceptable limits for elemental impurities to ensure patient safety. Identification of Potential Sources ... Read More
Classification of Elemental Impurities
The elemental impurity classes are: Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements ... Read More
Potential Sources of Elemental Impurities
In considering the production of a drug product, there are broad categories of potential sources of elemental impurities. The following diagram shows an example of typical materials, equipment and components used in the production of a drug product. Each of these sources may contribute elemental impurities to the drug product, ... Read More
Highlights of Recent FDA Guidance on Nitrosamine Drug Substance
For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
The EMA and other Health authorities have published requirements (EMA/189634/2019) and Health Canada Letter for the API industry and the MAH for drug products to expand the scope of potential sources of nitrosamines beyond that of ICH M7. This requirement is based on the fact that, as the Industry and ... Read More
Isolation and Identification of Impurities and Degradants
The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation to prevent these impurities and degradants. ... Read More
Best Practices to control N-Nitrosamine Impurities
N-Nitrosamine impurities are a major concern for pharmaceutical industry. Because it is regulatory requirement to control the nitrosamine impurities in human drugs. In this article we are sharing 10 best practices to control the nitrosamine impurites. Use high-quality raw materials: The quality of raw materials used in the manufacturing process ... Read More