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Elemental Impurities – Parenteral Dosage Form Case Study – Approach and Challenges
by J. Mason of Merck & Co., Inc., shared as part of the PQRI/USP Elemental Impurities Workshop (November 2016) on the PQRI website
Potential sources of impurity risks in a parenteral drug product: equipment, water, gases, excipients, drug substances and container closure systems.
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