Impurities in medicines can arise throughout the manufacturing process and even in transportation or storage. To minimize such risks, manufacturers must find ways to limit levels of impurities early and …

Finding and addressing impurities earlier in R&D and process development reduces the risk of unsafe impurity levels later in manufacturing processes, helping you stay on time and in compliance with …

Extractables and Leachables (E&Ls) are a subset of impurities derived from manufacturing systems, container closure systems, drug product delivery systems, and other packaging material that …

Jun 26, 2022 · Control of Impurities Manufacturers must employ measures for the proper control of unwanted impurities in dietary ingredients and dietary supplements. Manufacturers should consider …

Apr 25, 2025 · A major revision to the harmonized standard for 〈233〉Elemental Impurities—Procedures has been approved by the Pharmacopeial Discussion Group (PDG) as …

INTRODUCTION This chapter describes analytical procedures for the evaluation of elemental impurities that are suitable for the limits described in Elemental Impurities – Limits <232> and Elemental …

USP currently supports the following 17 peptide therapies, with oficial monographs published in the USP-NF. To support the development and manufacturing of these peptide therapies, USP also ofers …

<232> Elemental Impurities - Limits This General Chapter specifies limits for the amounts of elemental impurities in drug products. The limits presented in this chapter do not apply to excipients and drug …

Jan 1, 2018 · Rely on <233> Elemental Impurities -- Procedures for the analytical testing procedures rather than using the procedures in element specific chapters. Align the specific elemental impurities …

Opportunity to strengthen quality Manufacturers must control nitrosamine impurities in drugs because unacceptably high levels can delay product approvals, trigger product recalls, and otherwise disrupt …