Enantiomeric Purity Analysis of the Drug Product Atorvastatin on Lux® Amylose-1 According to the United States Pharmacopeia (USP) Monograph 2263
Enantiomeric Purity Analysis of the Drug Product Atorvastatin on Lux® Amylose-1 According to the United States Pharmacopeia (USP) Monograph 2263
17 Mar 2016The USP establishes methods and provides reference standards used by regulatory agencies and pharmaceutical manufacturers to ensure that APIs and drug products are of the appropriate identity, strength, quality, purity, and consistency. In the case of chiral drugs, such as Atorvastatin, a chiral HPLC method is generally used to assess chiral purity. This application note reports the enantiomeric separation between Atorvastatin Calcium (the Active Pharmaceutical Ingredient) depicted in Figure 1 and Related Compound E (enantiomer of Atorvastatin) using the new Lux Amylose-1 chiral stationary phase (CSP) according to the current USP method.
Related Products
Request Quote for All Products
Lux™ Chiral LC & SFC Columns
Phenomenex IncPolysaccharide Chiral HPLC and SFC Columns at a Very Affordable Price. Optimize your chiral separation and chiral purification with Lux® polysaccharide chiral HPLC columns. The Lux family of amylose and cellulose chiral selectors provides a variety of complementary selectivities that allow you to screen for the most effective chiral separation under Reversed Phase, Polar Organic, Normal Phase, and SFC conditions. With numerous publications in peer reviewed journals and countless applications being developed, Lux chiral HPLC columns are rapidly becoming the premier choice for simplified chiral purification and chiral separation worldwide. Column Details: Phase: Amylose-2, Cellulose-1,2,3,4 Particle Size: 3, 5, 10, 20 µm Pore Size: 1000 Å Length: 50, 100, 150, 250 mm ID: 2.0, 4.6, 10.0, 21.2, 30.0, 50.0 mm