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EP38767
Abstract: Active pharmaceutical ingredients (APIs) are the core of modern pharmaceutical products, and are also the basis of many innovative and effective therapeutic programs that have been applied and are being developed. To comply with these requirements and industry, clinical, and production best practices is absolutely necessary for any participant in the pharmaceutical product supply chain. Quality assurance, clinical trials and user assessment are key parameters for various stakeholders to review.
Summary: The latest USP/ USP-NF API analysis contains the identification of the chemical structure and the examination of validity, impurity and safety. Although USP now has removed and reduced properties test, but it can be used as a supplement to identification.References: Thurman, E. M., & Ferrer, I. (2010). ‘The isotopic mass defect: a tool for limiting molecular formulas by accurate mass.’ Analytical & Bioanalytical Chemistry, 397(7), 2807-2816.
R. Fr?tschl, & L. Müller. (2015). ‘Ich m7: guideline for the assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit carcinogenic risk.’ Bulletin of the School of Oriental & african Studies, 38(3), 658-661.
Niazi, S. K. (2009). ‘Good manufacturing practice guide for active pharmaceutical ingredients. Chapter, 376.’
Guideline, I. (2004). ‘Impurities in new drug substances. Q3a,’ 18(4), 118-122
https://www.alfachemic.com/testinglab/blog/active-pharmaceutical-ingredient-analysis.html
Summary: The latest USP/ USP-NF API analysis contains the identification of the chemical structure and the examination of validity, impurity and safety. Although USP now has removed and reduced properties test, but it can be used as a supplement to identification.References: Thurman, E. M., & Ferrer, I. (2010). ‘The isotopic mass defect: a tool for limiting molecular formulas by accurate mass.’ Analytical & Bioanalytical Chemistry, 397(7), 2807-2816.
R. Fr?tschl, & L. Müller. (2015). ‘Ich m7: guideline for the assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit carcinogenic risk.’ Bulletin of the School of Oriental & african Studies, 38(3), 658-661.
Niazi, S. K. (2009). ‘Good manufacturing practice guide for active pharmaceutical ingredients. Chapter, 376.’
Guideline, I. (2004). ‘Impurities in new drug substances. Q3a,’ 18(4), 118-122
https://www.alfachemic.com/testinglab/blog/active-pharmaceutical-ingredient-analysis.html
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