Rigorous and Attentive Service Related to Heparin Sodium Analysis at CD BioGlyco

CD BioGlyco provides flexible Pharmaceutical and Biological Analysis solutions to our clients. Heparin sodium is the sodium salt of sulfated glycosaminoglycan, formed by alternating linkages of O-sulfated alduronic acid and α-D-glucosamine. It is used in the study for a variety of diseases, including acute myocardial infarction. We provide a high-quality heparin sodium analysis service based on our rich experience in Pharmaceutical Analysis to support our clients' needs in related research. Our analytical services are available for heparin sodium, heparin sodium cream, and heparin sodium injection. The analytical protocols vary depending on the type of heparin sodium requested by our clients.

Heparin sodium analytical program at CD BioGlyco:

• Characterization: The appearance of the sample is observed and its specific rotation is detected.
• Molecular weight and distribution: We use molecular exclusion chromatography (MEC) to determine the molecular weight and distribution of the samples. The weight average molecular weight of heparin sodium should be 15,000-19,000.
• Total nitrogen: We detect the total nitrogen in the sample by nitrogen assay. The total nitrogen content of the sample should be 1.3% to 2.5% based on the dried product.
• Detection of related substances: The content of dermatan sulfate, etc., in samples, is detected by high-performance liquid chromatography (HPLC).
• Residual solvents: We detect the content of acetone, ethanol, and methanol in the samples by gas chromatography (GC).
• Loss on drying: The samples are placed in a phosphorus pentoxide desiccator and dried under reduced pressure until constant weight. Then the weight loss of the samples is calculated.
• Sodium (Na): Na is quantitatively analyzed using atomic absorption spectrophotometry. The Na content should be 10.5% to 13.5% based on the dried product.
• Potency determination: We perform potency determination by anti-factor IIa/anti-factor Xa potency assay. The potency of the samples is determined by comparing the activity of the heparin standard with that of the samples of anti-factor IIa and anti-factor Xa. The potency of the anti-IIa factor should be 90%-110% of the labeled value. The potency ratio of the anti-Xa factor to the anti-IIa factor should be by the regulations.
• Other related analyses: Heavy metals, clarity and color of the solution, bacterial endotoxin, sample identification, pH, microbiological detection, osmolality molar concentration, incineration residue, nucleic acid, protein content, etc.

Fig.1 Heparin sodium analysis service. (CD BioGlyco)

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Highlights of Us

• We have a dedicated team of analytical professionals. All the tests follow the pharmacopoeia of each country.
• We are equipped with specialized project leaders and project experts for each project to follow up and supervise the progress of the project promptly, to ensure that the project is delivered with high quality and high efficiency.
• We have a mature quality management system and are equipped with advanced analytical systems.

CD BioGlyco always puts the client in the center and develops the optimal pharmaceutical analysis solution. In addition to heparin sodium, we also provide Acarbose, Amikacin, and other analysis services. Please feel free to contact us to tell us about your needs regarding heparin sodium, heparin sodium cream, and heparin sodium injection analysis if you need in this regard.

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