Pharmaceutical Analytical Impurities - US Pharmacopeia (USP) 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 regulatory expectations
Extractables and Leachables - US Pharmacopeia (USP) 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 chemically react with drug product components, including Active Pharmaceutical Ingredients (API) and excipients E L impurities are commonly found in various complex drug products, including parenterals
Discover Impurity Reference Standards from USP Trust official USP Reference Standards, Pharmaceutical Analytical Impurities (PAIs), monographs and general chapters to help ensure accurate complex impurity profiling; develop robust, fit-for-purpose analytical methods; design appropriate stability studies and have confidence about your impurity controls
Elemental Impurities—Procedures - US Pharmacopeia (USP) A major revision to the harmonized standard for 〈233〉Elemental Impurities—Procedures has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page Learn more
232 ELEMENTAL IMPURITIES—LIMI - US Pharmacopeia (USP) INTRODUCTION This general chapter specifies limits for the amounts of elemental impurities in drug products Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products These impuri-ties may occur naturally, be added intentionally, or be introduced inadvertently (e g , by interactions with processing equip-ment and
Microsoft Word - 233 Elemental Impurities--Procedures 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 Contaminants in Dietary Supplements <2232> Two procedures and criteria for the acceptability of alternative procedures are described Alternative procedures that meet the validation requirements
Microsoft Word - 232 Elemental Impurities--Limits <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 substances, except where specified in this chapter or in the individual monographs However, elemental impurity levels present in drug substances and excipients must be known and reported
~h232i ELEMENTAL IMPURITIES— LIMITS - US Pharmacopeia (USP) Class 1 Elemental Impurities Compliance with the limits specified for Class 1 ele-mental impurities is required for all drug products, re-gardless of the likelihood of the presence of impurities The presence of unexpected elemental contaminants, as well as that of impurities likely to be present, should be considered in determining compliance and planning the risk-based extent of testing