Radiochemical Purity Evaluation Services
Rdcthera is a leading CRO offering extensive radiochemical purity analysis services. We commit ourselves to the development of radiopharmaceuticals through the most stringent testing and analysis to ensure the highest standards of quality for our clientele.
What is Radiochemical Purity?
Radiochemical purity is an important index in evaluating radiopharmaceuticals. It is defined as the percentage of total radionuclides in a radioactive sample that are present in a specific chemical form. To meet the regulatory approval of radiopharmaceuticals, a high RCP is mandatory, and establishing methods for the accurate, rapid, and convenient analysis of radiochemical purity is a critical issue in the clinical translation and development of novel radiopharmaceuticals. Rdcthera offers one stop solution for radiochemical purity analysis.
Fig. 1. Radiochemical purity of radiolabeled compounds measured by HPLC. (Wen X, et al., 2022)
Comprehensive Radiochemical Purity Evaluation Services
Rdcthera has established accurate, rapid, and convenient methods for radiochemical purity analysis. A comprehensive radiochemical purity assessment service is provided for clients to ensure that results are accurate, reliable, and meet the highest industry standards.
- Radiochemical Purity Evaluation Services
Our services for the determination of radiochemical purity are designed to give clear and total analytical information of radiopharmaceuticals by different advanced techniques.
- High-Performance Liquid Chromatography
We offer HPLC for high-precision separation and quantitative determination of radiochemicals. High resolution and sensitivity of this technology make it perfect for the identification of impurities and degradation products. Our state-of-the-art HPLC systems, with various detectors, help us to develop, optimize and validate reliable methods for specific radiopharmaceuticals.
- Thin-Layer Chromatography
We offer our clients the TLC technique for the estimation of radiochemical purity. TLC requires minimal sample preparation, is cost-effective, and gives a quick turnaround. Our fully-featured TLC setup with automated detection systems provides the exact interpretation of chromatograms and reliable quantification of radiochemical purity.
High sensitivity and high specificity gas chromatography is conducted to detect radiochemical purity in the analysis of volatile radiochemicals and organic solvents.
We provide radioelectrophoresis for purity determination and are suitable for complicated ion mixtures. Our radioelectrophoresis instruments are fully equipped and dealt with skilled technicians for the purpose of accurate processing and interpretation of electrophoretic separation results.
- Method Development and Validation
We offer method development and validation services to our customers through the development of a method tailor-made for each specific radiopharmaceutical to meet particular project needs.
We offer full regulatory support with complete documentation and assistance in meeting all the necessary guidelines and standards to help smooth your path to translation.
To learn more about our services related to radiochemical purity evaluation or to discuss your specific needs, please contact us today. Rdcthera looks forward to cooperating with you for the advancement of the radiopharmaceutical sector.
Reference
- Wen X, Shi C, Yang L, et al. (2022). A radioiodinated FR-β-targeted tracer with improved pharmacokinetics through modification with an albumin binder for imaging of macrophages in AS and NAFL. Eur J Nucl Med Mol Imaging. 49(2):503-516.
For research use only. Not intended for any clinical use.
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