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Note for guidance on specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances ICHQ6A (CPMP/ICH/367/96

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Elder, D. P. and Snodin, D. J. (2009), Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation. Journal of Pharmacy and Pharmacology, 61: 269

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Analytical Profiles of Drug Substances and Exc

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Guideline to Registration of Drug Substances(英

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TICAL PROFILES OF DRUG SUBSTANCES 【

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