FDA Guidance for Industry: Q3D(R2) ELEMENTAL IMPURITIES

Title:
FDA Guidance for Industry: Q3D(R2) ELEMENTAL IMPURITIES

https://www.gmp-compliance.org/files/guidemgr/38535536_Q3D(R2) Draft Guideline.pdf

Origin/Publisher:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613410.pdf

Content:
Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits.

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