Nettet4. aug. 2024 · High-molecular weight products (HMWP) are an important critical quality attribute in research and development of insulin biopharmaceuticals. We here demonstrate on two case studies of covalent insulin dimers, induced by Fe 2+ incubation or ultraviolet (UV) light stress, that de novo characterization in top-down mass … Nettet14. jan. 2015 · Purpose To identify High Molecular Weight Products (HMWP) formed in human insulin formulation during storage. Methods Commercial formulation of human insulin was stored at 37°C for 1 year and HMWP was isolated using preparative size exclusion chromatography (SEC) and reverse phase (RP) chromatography. The …
Formation of subvisible particles in commercial insulin …
Nettet5. sep. 2024 · Simultaneous characterization of insulin HMWP and protamine sulphate in complex formulations through SEC-coupled mass spectrometry. Author links open overlay panel Koduru ... Further investigations under stress conditions of Insulin analogues revealed the capability of the method to separate higher order … Nettet9. mar. 2005 · Determination of the covalent insulin protamine product (CIPP) formed during storage [7], especially at accelerated storage conditions, was performed by using a size exclusion chromatographic (SEC) method equivalent to the high molecular weight protein (HMWP) method adopted in the European Pharmacopoeia monograph for … convalescent homes burbank ca
Simultaneous characterization of Insulin HMWP and
NettetWaters Insulin HMWP Gel Filtration HPLC Column is designed specifically for use in the manufacture and quality control of insulin products. Waters has tested this column for … Nettet1. aug. 2024 · Morphologic characterization of insulin HMWP by TEM. The insulin formulations (regular H, regular N, LisPro and Aspart, as indicated) were aliquoted at baseline and after 35 d of successive weekly handling and stored at 4 °C and 37 °C as indicated, deposited onto Formvar-coated copper grids, negative stained and examined … NettetDuring the 6-day sampling period, the potency of all insulin samples was maintained at 95.0–105.0% of the bulk solution concentration of the insulin vials. The levels of HMWP and related substances remained well below labeling limits. The preservative concentration decreased with time but remained bacteriostatic effective. convalescence cat food