Pharmaceutical
From Sample Preparation to Analysis, We Have You Covered
The analysis of pharmaceutical molecules provides challenges which we aim to help you overcome. From sample preparation of PK/ADME samples, to complex HPLC/UHPLC separations and residual solvent analysis we have the solutions you need. We provide:
- Method development/pharma workflow support,
- Troubleshooting for sample preparation, HPLC, and GC
- Cost effective analytical solutions.
Discover a variety of pharmaceutical solutions tailored to you. You can also easily access the Nitrosamines and NDSRI application portal.
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Therapeutic Peptides
Therapeutic peptides are short chains of amino acids that have emerged as a promising class of drugs due to their high specificity, potency, and favorable safety profiles. They mimic natural peptides in the body, allowing them to engage with specific receptors and pathways involved in various physiological processes. This makes them particularly effective in treating a wide range of conditions, including metabolic disorders, cancer, and infectious diseases. Their small size and ability to be easily modified for improved stability and delivery further enhance their therapeutic potential. As a result, therapeutic peptides are becoming increasingly important in the development of novel treatments with fewer side effects compared to traditional small molecule drugs.
High-Performance Liquid Chromatography (HPLC) is a vital technique for purifying therapeutic peptides, ensuring their efficacy and safety. By exploiting differences in peptide properties such as size, charge, and hydrophobicity, HPLC effectively separates and isolates the desired peptide from impurities and by-products. The method's high resolution and precision make it ideal for producing peptides with high purity, which is crucial for clinical applications. Additionally, HPLC can be scaled up for industrial production, providing a reliable and consistent means of purification. This ensures that therapeutic peptides meet stringent regulatory standards, ultimately leading to more effective and safer treatments for patients.
GLP-1 (Glucagon-Like Peptide-1) analogues are a specific focus, with their potential to regulate blood sugar levels, slowing gastric emptying and promoting a feeling of fullness. Several drugs are already on the market (semaglutide, dulaglutide, exenatide and liraglutide) and finding successful strategies for the purification and quality assurance of these therapeutic peptides is of current interest to many pharmaceutical companies.
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Originator Pharmaceutical Drug Development
Our team of experts understand the challenges associated with developing methods to support small molecule Drug development and analysis. Let us help you to utilise our portfolio of HPLC and UHPLC products to your benefit during method development and validation.
- Tackle challenging separations with our broad portfolio of stationary phase selectivities
- Achieve the sensitivity you need with our core-shell LC products
- Cleanup complex PK/ADME sample matrices to ensure reliable metabolite quantitation
- Support you with forced degradation studies
- Reliably run your pharma workflows, day after day, with reproducible HPLC and UHPLC columns
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Generic Pharmaceuticals
Bringing drugs to market in a quicker, more affordable manner poses significant challenges. We have solutions allowing you to reduce analysis time and cost, giving you a competitive advantage.
- Pharmacopeia monograph method examples run on our HPLC/UHPLC column portfolio for both the United States Pharmacopeia (USP) and European Pharmacopeia (EP)
- Listings of pharmacopeia columns (both USP and EP) to allow for ease of column selection
- Core-shell columns offer increased sample throughput
- Details of allowable adjustments that can be made to pharmacopeia monographs (United States Pharmacopeia Chapter 621 and European Pharmacopeia 2.2.46) to save you time and money.
- USP and Ph.Eur. Calculator to perform necessary calculations when making allowable adjustments according to USP Chapter 621 or Ph. Eur. 2.2.46.
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Active Pharmaceutical Ingredient Manufacturing
When developing your method we offer high resolution core-shell and thermally modified particles to provide you with high resolution separations to help you resolve related organic impurities from your API. We can provide support in method development, proposing suitable stationary phases in combination with mobile phases together with screening recommendations to save time and money. We also offer products which are scalable, for those separations where chromatographic purification is the only option.
- From molecular properties to LC method, just give us a call
- Kinetex core-shell columns providing high efficiency on any system, scalable from uHPLC to HPLC to preparative
- Luna Omega thermally modified fully porous materials providing the highest level of inertness to reduce tailing and enhance resolution
- Chromatographic library available to provide starting points for method development
For further information on our pre-packed preparative columns manufactured using AXIA technology, please click here. We also offer bulk material for DAC systems, further details can be found by following this link.
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