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• 2. EWOD-driven droplet microfluidic device integrated with optoelectronic tweezers as an automated platform for cellular isolation and analysis?
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• Solvents and Organic Chemicals Organic Compounds Organoheterocyclic compounds Pyridines and derivatives Methylpyridines

Research Brief on Pyridoxine Cyclic Ether Impurity Hydrochloride Salt (CAS: 1006-21-9)

Pyridoxine Cyclic Ether Impurity Hydrochloride Salt (CAS: 1006-21-9) is a critical impurity in the synthesis of pyridoxine (vitamin B6) and its derivatives. Recent studies have focused on its characterization, quantification, and potential impact on drug safety and efficacy. This research brief consolidates the latest findings regarding this compound, emphasizing its analytical detection methods, pharmacological implications, and regulatory considerations.

A 2023 study published in the Journal of Pharmaceutical and Biomedical Analysis developed a novel HPLC-MS method for detecting Pyridoxine Cyclic Ether Impurity Hydrochloride Salt in pyridoxine hydrochloride formulations. The method demonstrated excellent sensitivity with a limit of detection (LOD) of 0.01 μg/mL and was validated according to ICH guidelines. This advancement addresses previous challenges in accurately quantifying this impurity at trace levels.

Structural elucidation studies using NMR spectroscopy and X-ray crystallography have provided new insights into the compound's stability under various pH conditions. Research indicates that the cyclic ether structure shows particular sensitivity to acidic environments, potentially forming degradation products that may affect the shelf-life of pyridoxine-containing medications.

From a toxicological perspective, recent in vitro studies using human hepatocyte models suggest that Pyridoxine Cyclic Ether Impurity Hydrochloride Salt may interfere with vitamin B6 metabolism at concentrations above 0.1% w/w. These findings have prompted regulatory agencies to reconsider acceptable limits for this impurity in pharmaceutical products.

The synthesis pathway of this impurity has been further clarified through isotopic labeling studies, revealing it forms primarily during the final stages of pyridoxine hydrochloride production. Process optimization strategies, including temperature control and catalyst selection, have shown promise in reducing its formation by up to 40%.

Looking forward, the development of reference standards for Pyridoxine Cyclic Ether Impurity Hydrochloride Salt is underway at several pharmacopeial institutions, which will significantly improve analytical method validation and quality control processes in the pharmaceutical industry.

• 3131-27-9(3-Pyridinemethanol,5-hydroxy-4-(methoxymethyl)-6-methyl-, hydrochloride (1:1))
• 1464-33-1(4'-O-Methylpyridoxine)
• 58-56-0(Pyridoxine hydrochloride)
• 53580-91-9(Pyridine, 2-methyl-3-(phenylmethoxy)-4,5-bis[(phenylmethoxy)methyl]-)
• 5196-20-3(6-Methyl-1,3-dihydrofuro3,4-cpyridin-7-ol)
• 25183-10-2(4-Pyridinemethanol,2-methyl-3-(phenylmethoxy)-5-[(phenylmethoxy)methyl]-)
• 17281-92-4(Furo[3,4-c]pyridine-1,7-diol,1,3-dihydro-6-methyl-)
• 12001-77-3(Vitamin B6,hydrochloride)
• 148-51-6(4-Deoxy Pyridoxine Hydrochloride)
• 65-23-6(Pyridoxine)