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Management of organic impurities in small molecule medicinal products is regulated by a number of guidelines (ICH Q3A (R2), 2006, ICH Q3B (R2), 2006, ICH Q3C (R5), 2011, ICH M7, 2016).
Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or unidentified, volatile or non-volatile,
Read answers to frequently asked questions about USP's rationale for proposed standards for organic impurities.
This guidance note covers requirements for controlling organic process-related impurities and degradation products in APIs and FPPs, and provides guidance on how to assess compliance with Ph.Int. requirements.
Inorganic impurities can result from the manufacturing process. Their main difference from organic impurities is that they are usually known and identified. Inorganic impurities include reagents, ligands, catalysts, heavy or other residual metals, and inorganic salts. The main sources of heavy metals are the water
The organic impurities can arise from the manufacturing process and/or be formed during storage of the drug substances. They include starting materials, by-products, synthetic intermediates, degradation products, reagents, ligands and catalysts.
Organic impurities can arise during the manufacturing process and/or storage of the drug substance. They can be identified or unidentified, volatile or nonvolatile, and include the following: Inorganic impurities can result from the manufacturing process. They are normally known and identified and include the following:
This chapter covers formal requirements for controlling organic process impurities and degradation products in drug substances, and degradation products in drug products. Impurities are critical quality attributes of drug substances and drug products because they have the potential to affect safety and efficacy.
As part of an ongoing initiative to modernize monograph standards, USP has proposed drafts of new and revised general chapters related to organic impurities in drug substances and drug products.
This document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State.
The organic impurities to be controlled in the drug substance are the process impurities (starting materials, byproducts, intermediates, reagents, ligands, and catalysts) and
This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances.
Organic impurities, often called related, ordinary or synthesis-related impurities can originate from various sources and from various phases of the synthesis of bulk drugs and the preparation of pharmaceutical dosage forms.
