What are USP’s expectations relating to General Chapter <467> between now and July 1, 2008 and after July 1, 2008 for all pharmaceutical companies? The USP General Notices require all products to meet the requirements in General Chapter <467> by July 1, 2008.

Understand the historical approaches and standards contained in USP General Chapter <467>. Apply a risk-based strategy concept for complying with residual solvents content in pharmaceutical requirements of USP <467>. Illustrate Options 1 and 2, as well as Procedures A, B, and C as described in USP <467>.

The application of <467> Residual Solvents to all USP-NF official articles is a requirement articulated through the USP-NF General Notices 5.60.20 since its inception:

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ROCKVILLE, MD, March 8, 2024 - As a public standards-setting organization committed to safeguarding public health, the U.S. Pharmacopeia (USP) reviewed the recent Citizen Petition to the U.S. FDA by a third-party laboratory testing company. Its study described in the Citizen Petition found high levels of benzene, a known carcinogen, in commonly used topical acne …

Si la USP está trabajando en armonizar los Capítulos Generales USP, ¿por qué la USP no armoniza por completo el capítulo 467> con la Farmacopea Europea antes de implementar el capítulo? Existen únicamente unas diferencias menores entre los métodos de la USP y la Farmacopea Europea.

2016年6月1日 · the charge to: “Rewrite Chapter <467> Residual Solvents” A survey was conducted in the Pharmaceutical Industry during 2013 on the use of the chapter and ways to improve and enhance it. Proposed Revision was published in Pharmacopeial Forum 41 (5). A total of 136 comments/suggestions were received from 22 organizations.

No. If the product or substance is covered by a USP or NF monograph, the monograph standards and the General Notices apply, whether or not it is labeled "USP" or "NF", The General Notices requirement that the substance or product comply with <467> applies to all substances and products covered by USP and NF monographs.

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2024年3月8日 · peroxide and its dosage forms and General Notice 5.60.20 Residual Solvents in USP and NF Articles, which states that the requirements of the USP General Chapter <467> Residual Solvents are applicable to all United States Pharmacopeia and the National Formulary articles. General Chapter <467> states that no more than (NMT) 2 parts per million ...