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FDA Guidance for Industry: Q3D(R2) ELEMENTAL IMPURITIES

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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