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in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024. Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes.
Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024. In the document, the following leachables thresholds were recommended – parts per million (ppm): Reporting threshold: 1 ppm.
On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Chaudhary explained the necessity of sampling excipients and the exemption for dedicated facilities.
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