Using Superficially Porous Particles and Ultrahigh Pressure Liquid Chromatography in Pharmacopeial Monograph Modernization of Common Analgesics

Author:

Kresge Glenn A.,Wong Jenny-Marie T.,De Pra Mauro,Steiner Frank,Grinias James P.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry

Reference77 articles.

1. Santos LM, Davani B, Anthony CM, Clark JE (2015) USP monograph modernization initiative. Am Pharm Rev 18(2)

2. Russo K, Dressman S (2011) Monograph makeover requires industry input. Pharm Technol 35:90–94

3. Alsante KM, Huynh-Ba KC, Baertschi SW et al (2014) Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: safety considerations of impurities in pharmaceutical products and surveying the impurity landscape. AAPS Pharm Sci Technol 15:237–251. https://doi.org/10.1208/s12249-013-0061-z

4. United States Pharmacopeial Convention (2017) Chromatography. In: United States Pharmacopeia and National Formulary (USP 40-NF 35), Rockville, pp 8071–8082

5. Dolan JW (2017) Method adjustment the USP way. LC-GC North Am 35:368–373

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