Application Notes: Pharmaceuticals

Monoclonal antibodies (mAbs) are effective therapeutics for cancers, auto-immune diseases, viral infections, and other diseases. Recent developments in antibody therapeutics aim to add more specific binding regions (bi- and multi-specificity) to increase their effectiveness and/or to downsize the molecule to the specific binding regions (for example, scFv or Fab fragment) to achieve better penetration of the tissue. As the molecule gets more complex, the possible high and low molecular weight (H/LMW) impurities become more complex, too. In order to accurately analyze the various species, more advanced detection than ultraviolet (UV) is required to characterize a mAb sample.

Wyatt’s instruments and techniques constitute platform methods for effective product and process development, as well as quality control, of AAVs for gene therapy.

Efficient and accurate HPLC analysis of lamotrigine in compliance with USP

USP-compliant assay analysis of hydrocortisone using a PerkinElmer LC 300 HPLC System

Efficient and compliant HPLC analysis of pregabalin

A rapid and simple LC method for the analysis of six common VOC metabolites in urine for monitoring occupational exposure to VOCs

This application notes introduces an SPE LC–MS/MS methodology using the Microlute™ CP SCX SPE 96-well microplate for the determination of 12 opioids from human urine.

We show the separation of tacrolimus from its related substances following Ph. Eur. monograph 2244 using the Luna 3 µm C18(2) and Luna Omega µm.

We report the separation of diazoxide and its related organic impurities using a Kinetex ™2.6 µm biphenyl column according to the USP monograph for diazoxide.

This step-by-step selectivity guide is an overview of the reversed-phase HPLC/UHPLC options available to you, highlighting the differences between the columns.

LC–UV assay and organic impurities for paliperidone drug substance based on USP monograph where a L1 (C18) column with 100 x 4.6 mm, 3 µm dimensions was used

LC–MS/MS method to separate furosemide and its metabolite using three different columns: Kinetex 2.6 µm Biphenyl, Luna Omega 1.6 µm C18, and Luna Omega 1.6 µm Polar C18

Luna Omega 1.6µm, 3µm, and 5µm HPLC/UHPLC columns culminate 20 years of technological prowess, advancements, and innovation.

Easily determine the allowable adjustments that can be made to European Pharmacopoeia (EP) methods and find the right column for your method.

Quickly view allowable adjustments outlined by the United States Pharmacopeia (USP) and select the proper Phenomenex column for your monograph using this simple guide.

Analysis of ABN7 test mix used to assess scalability for Luna Omega C18 columns across a range of particle sizes (1.6 µm, 3 µm, and 5 µm) in three different dimensions.

Improve United States Pharmacopeia (USP) method performance with allowable adjustments

 In this application note we demonstrate the excellent performance of Sapiens-624MS columns for the analysis of e-liquids based on ISO 20714.

The fight against cancer employs many tools. Paclitaxel, a compound found in the bark of the Pacific yew tree, is one that that has been found to make a big difference.

The pharma industry is embracing the challenge of sustainability by using greener solvents. A GC–MS method for analyzing 32 green solvents is presented.  

To monitor FcR receptor binding, a recombinant FcγRIIIa-ligand has been commercialized into TSKgel FcR-IIIA high-performance affinity chromatography (AFC) columns that separate antibodies based on affinity differences to FcγRIIIa.

This technical article outlines the analysis of long-chain oligonucleotides utilizing a simple eluent containing acetonitrile with a relatively low level of salt and no ion-pair reagent.

Purification of peptide-peptoid hybrids can be obtained by reversed phase chromatography with excellent recovery and resolution.

The ability to collect compounds is directly related to the ability to detect them. Many compounds possess weak or non-existent chromophores which causes UV detection to exhibit poor yields.

This methodology demonstrates an efficient approach for identity and stability testing of lipids and lipid-based formulations like mRNA vaccines by HPTLC.

The fight against cancer employs many tools. Paclitaxel, a compound found in the bark of the Pacific yew tree, is one that that has been found to make a big difference.

In this application note we demonstrate the excellent performance of Sapiens-624MS columns for the analysis of e-liquids based on ISO 20714

The PRP–C18 isolates structurally diverse pharmaceutical compounds in under 6 min using basic solutions.  

This application note demonstrates robust, sensitive quantitation of 10 nitrosamines, and the use of the LC–SRM-MS method to quantify nitrosamine impurities in metformin.

This application note demonstrates fast, highly sensitive quantitation of nine nitrosamines, and the use of the LC–MS method to measure nitrosamine.