Biotin sulfone
Product Code：B042024
English Name：Biotin sulfone
English Alias：5-((3aS,4S,6aR)-5,5-dioxido-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid
CAS No.：40720-05-6
Molecular Formula：C₁₀H₁₆N₂O₅S
Molecular Weight：276.31
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Biotin impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in methanol-water solution within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of sulfone impurities in Biotin API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Biotin sulfone formation during Biotin synthesis or storage, reducing generation by >40% by adjusting oxidation conditions (e.g., temperature ≤30℃, avoiding strong light).
Metabolic Studies：As the final oxidation product of Biotin in vivo or in vitro, used to study Biotin's oxidative metabolic pathway and assist in evaluating drug stability during storage and metabolism.
Biotin, an essential water-soluble vitamin, is widely used in pharmaceuticals, food, and cosmetics. Biotin sulfone, a sulfone oxidation impurity of Biotin, may form during production due to over-oxidation or exposure to oxidants (e.g., peroxides, oxygen) during storage. Its sulfone group (-SO₂-) significantly alters molecular polarity, potentially affecting Biotin's biological activity and product stability. With stricter FDA and EMA requirements for drug impurities, studying this impurity is crucial for ensuring Biotin product quality.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 5 minutes, with LOD of 0.003 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by two-step oxidation of Biotin's thioether group, accelerated by light, high temperature, or metal ions (e.g., Fe³⁺). Inhibition is achieved by adding antioxidants (e.g., vitamin E) or using inert gas protection.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 215.6 μM against HEK293 cells (Biotin has no significant toxicity), with low toxicity but requiring ≤0.1% control. Long-term stability testing monitors degradation under different humidity (40%-75%RH), light (4500lx), and temperature (25℃/60℃) conditions.
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E-mail: anna@molcoo.com
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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