Rapid and high-resolution analysis of sodium heparin using the APC system

Rapid and high-resolution analysis of heparin sodium using ultra-efficient polymer chromatography (APC) system Sun Qinglong, Qian Kejun, Mao Yanni Waters Technology (Shanghai) Co., Ltd.

Application advantages:
â–  Significantly shortens the analysis time of heparin sodium compared to conventional GPC analysis
â–  Rapid monitoring of heparin sodium for early detection of changes in product development and quality control

As an anticoagulant, heparin has been officially used in clinical treatment since 1935 for nearly 80 years. At present, heparin is still the most effective and clinically most used anticoagulant in the world, and has been accepted by the Pharmacopoeia of many countries in the world. In China, heparin drugs have not only successfully entered the national basic medical insurance catalog, but also raised the price of medicines for a small number of prices. In addition, heparin is the only anticoagulant that has entered the national essential medicines list. Due to the rapid expansion of the heparin drug market in its downstream products and maintaining rapid growth, the demand for heparin bulk drugs in the international market is very strong. In particular, heparin API products whose quality meets the US FDA certification or the EU CEP certification standards have been in short supply and become an important resource for global downstream manufacturers.

After the recent exposure of heparin safety incidents, the quality of heparin sodium APIs has been highly concerned by the global heparin drug companies, and the market supervision has been surging. Companies are under pressure to improve the testing standards for heparin APIs, increase costs, and become more stringent in terms of environmental standards and energy conservation.

This application compares separations based on ACQUITY APCTM ultra-high performance polymer chromatography systems with conventional GPC-based separations and uses a low-diffusion system with sub-3 μm hybrid particle technology columns to speed up analysis and increase Resolution. The combined use of these techniques enables the determination of molecular weight parameters of heparin more stably, more accurately, and more rapidly.

This application compares separations based on ACQUITY APCTM ultra-high performance polymer chromatography systems with conventional GPC-based separations and uses a low-diffusion system with sub-3 μm hybrid particle technology columns to speed up analysis and increase Resolution. The combined use of these techniques enables the determination of molecular weight parameters of heparin more stably, more accurately, and more rapidly.

Heparin sodium analysis: breakthrough in productivity

Waters Solutions
â–  ACQUITY APC Ultra High Performance Polymer Chromatography System
â–  ACQUITY APC AQ Column
■ Empower® 3 Chromatography Data Software with GPC Option

Experimental conditions:

ACQUITY APC system conditions <br> Detector: ACQUITY® RI (differential detector)
RI flow cell: 35 °C
Mobile phase: 100 mMol ammonium acetate aqueous solution flow rate: 0.6 mL/min
Column: ACQUITY APC AQ 200 Ã… column, 4.6 x 150 mm
Column temperature: 35 °C
Sample diluent: ammonium acetate aqueous solution injection volume: 10 μL

Data processing software:
Empower 3 Chromatography Data Software

sample:
5 mg/mL sodium heparin

Results and discussion:
The Water Quality ACQUITY APC (Advanced Polymer Chromatography) ultra-high performance polymer chromatography system is a breakthrough technology based on the principle of size exclusion chromatography, providing you with more detailed information on polymer materials at an unprecedented rate of analysis.

ACQUITY APC reduces run time and helps monitor heparin feedstock and manufacturing processes to facilitate the development of heparin sodium and speed time to market.

Compared to conventional GPC systems, the ACQUITY APC system has a lower degree of diffusion and therefore produces less peak broadening. In addition, the low-diffusion APC system combined with a stable sub-3 μm APC column technology that supports higher flow rates and back pressures improves resolution of heparin samples and reduces analysis time by a factor of seven.

Thoracoscopy Instruments

We're professional Thoracoscopy Instruments manufacturers and suppliers in China, specialized in providing high quality medical instruments with reasonable price. We warmly welcome you to buy or wholesale bulk Thoracoscopy Instruments for sale here and get quotation from our factory.

Thoracoscopy Instruments,Thoracic Instruments,Thoracotomy Instruments,Thoracotomy Set Instruments

Tonglu WANHE Medical Instrument Co., Ltd , https://www.vanhurhealth.com