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Guidance 18: Impurities in drug substances and drug products

(Updated from ARGPM Appendix 18: Impurities in active pharmaceutical ingredients and finished products)

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG)

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This guidance provides sponsors with the information requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

Contents

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 09/08/2013

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