Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced.
Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed.
Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies.
Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc.
Liquid chromatography mass spectrometry (LC-MS) is a powerful analytical chemistry tool used in the pharmaceutical, biotechnological, and environmental industries. This equipment combines the separation capabilities of high-pressure liquid chromatography (HPLC) and the mass analysis capabilities of mass spectrometry to provide very sensitive and specific detection of a wide range of molecules.
Samples containing complex mixtures of compounds are pumped through a chromatography column and separated into its components, mainly based on polarity of the molecules. As each component appears at the end of the column, they are channeled into the ion source, where the solvent is removed, and compounds become ionized before entering the mass analyzer and mass detector. The mass analyzer sorts ions by their masses (expressed as mass to charge ratio, or m/z), and the mass detector determines the abundance of each ion. There are different ion sources that use slightly different mechanisms for creating ions.
Tandem LC-MS (LC-MS/MS) is used as an analytical tool to detect and quantify molecules in a variety of samples.
Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) is a powerful analytical technique that combines the separating power of liquid chromatography with the highly sensitive and selective mass analysis capability of triple quadrupole mass spectrometry.
The strength of this technique lies in the separation power of LC for a wide range of compounds combined with the capability of the MS to quantify compounds with a high degree of sensitivity and selectivity based on the unique mass/charge (m/z) transitions of each compound of interest.