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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)
This guidance provides sponsors with the information requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Office of Medicines Authorisation||09/08/2013|