Cytarabine Analysis Service

Drive Accuracy with Our Cytarabine Analysis

The purpose of the detection technologies used for cytarabine is to determine its presence and purity and to ensure its safety, efficacy, and quality. As one of the important services of Pharmaceutical and Biological Analysis Services, CD BioGlyco provides a comprehensive cytarabine analysis, including but not limited to identification, quantitative analysis, impurity tests, and specific tests.

Fig.1 Cytarabine analysis service. (CD BioGlyco)Fig.1 Cytarabine analysis service. (CD BioGlyco)

  • Identification
    • Determining melting point: We preliminarily evaluate the presence of cytarabine by measuring the melting point.
    • Infrared spectroscopy (IR): We identify the functional groups and chemical bonds of cytarabine through IR, which helps determine its crystal form and isomers.
    • Hydrogen nuclear magnetic resonance spectrum (1H-NMR) and carbon spectrum (13C-NMR): Through this analysis, we gain an in-depth understanding of the chemical environment of hydrogen and carbon atoms within the cytarabine molecule, thereby determining the internal configuration and conformation of the molecule.
    • X-ray Diffraction: We use X-ray diffraction to determine the crystal structure and morphology of cytarabine.
  • Quantitative analysis
    • Ultraviolet-visible spectroscopy (UV-Vis): We use the standard curve method or the comparative method to determine the content of cytarabine by measuring its absorbance at a specific wavelength. This method is simple and fast.
    • High-performance liquid chromatography (HPLC): This method provides an efficient means to separate and detect individual components within complex samples. By using different columns and detectors, we accurately determine the content of cytarabine; known for its high resolution and sensitivity.
    • Titration method: Cytarabine reacts chemically with a reagent of known concentration, and we determine the content of cytarabine through the titration process.
  • Impurity tests
    The main methods are detection through HPLC and gas chromatography (GC). These methods can separate and detect impurities in cytarabine, thereby controlling its purity.
  • Specific tests
    Specific tests mainly include optical rotation, loss on drying, sterility tests, bacterial endotoxins tests, etc. These tests are used to evaluate the quality and safety of cytarabine.
    • Optical rotation: We determine the optical purity of cytarabine by measuring its optical rotation. This method is capable of detecting chiral impurities.
    • Loss on drying: We evaluate the moisture content and stability of cytarabine by measuring the loss on drying.
    • Sterility tests: Through sterility testing and microbial limit testing, we evaluate the sterility status and degree of microbial contamination of cytarabine to ensure its safety and effectiveness. This method provides rigorous and accurate results.
    • Bacterial endotoxins tests: We evaluate the sterility status and degree of microbial contamination of cytarabine to ensure its safety and effectiveness through sterility testing and microbial limit testing. This method provides rigorous and accurate results.

Importantly, we also provide an analysis of cytarabine for injection. For the analysis of cytarabine for injection, the following specific tests are added in addition to all cytarabine analysis items: pH, water determination, constituted solution, and sterility tests.

Publication Data

Technology: Liquid chromatography tandem mass spectrometry (LC-MS/MS)

Journal: Journal of Pharmaceutical and Biomedical Analysis

IF: 3.571

Published: 2016

Results: The author presents a procedure for the simultaneous determination of clofarabine and cytarabine in human plasma. Extraction of these substances from plasma samples was achieved through protein precipitation with acetonitrile. Analyte separation was performed on a column, with subsequent detection conducted using a triple-quadrupole MS with an electrospray ionization source. The mobile phase was constituted by a blend of acetonitrile, ammonium acetate, and formic acid and used in gradient mode at a 0.5 mL/min rate of flow. Calibration ranges were separately established for both clofarabine and cytarabine as 8-1000 ng/mL and 20-2500 ng/mL respectively.

Here are some of the results shown in this article:

Fig.2 LC–MS/MS chromatograms. (Büttner, et al., 2016)Fig.2 LC-MS/MS chromatograms. (Büttner, et al., 2016)

CD Bioglyco provides clients with professional Pharmaceutical Analysis Services to ensure the quality, safety, and effectiveness of drugs. In terms of cytarabine analysis service, we have a professional research team that conducts comprehensive and accurate detection and analysis of cytarabine. In addition, we also offer analysis of cytarabine for injection to meet the needs of our clients. Please feel free to contact us if you need cytarabine or cytarabine for injection analysis service.

Reference

  1. Büttner, B.; et al. Simultaneous determination of clofarabine and cytarabine in human plasma by LC-MS/MS. Journal of Pharmaceutical and Biomedical Analysis. 2016, 125: 286-291.
This service is for Research Use Only, not intended for any clinical use.

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