Keywords

• N-Nitroso-Biotin
• 56859-26-8
• C10H15N3O4S

Quick Details

• ProName: N-Nitroso-Biotin
• CasNo: 56859-26-8
• Molecular Formula: C10H15N3O4S
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details

WhatsAPP: +86 17320513646                      E-mail: anna@molcoo.com

Product Information

• Product Code：B042022
• English Name：N-Nitroso-Biotin
• English Alias：5-((3aS,4S,6aR)-1-nitroso-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid
• CAS No.：56859-26-8
• Molecular Formula：C??H??N?O?S
• Molecular Weight：273.31

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS, suitable for precise analysis of nitrosamine impurities in biotin and its formulations.
• Stability Assurance：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in DMSO solution within 3 months.

Applications

• Drug Safety Testing：Used for LC-MS/MS detection of N-nitroso impurities in biotin API and formulations, complying with ICH M7 guidelines for genotoxic nitrosamine control (≤0.1 ppm).
• Process Risk Assessment：Monitors N-Nitroso-Biotin generated from nitrosation side reactions during biotin synthesis, reducing impurity levels by optimizing reaction conditions (e.g., avoiding sodium nitrite excess, controlling acidic pH).
• Method Validation：Serves as a standard for developing nitrosamine detection methods, verifying sensitivity (LOD down to 0.01 ng/mL) and specificity.

Background Description

Biotin, a water-soluble vitamin, is commonly used to treat hair loss, brittle nails, and other conditions. N-nitroso compounds (such as N-Nitroso-Biotin) are prioritized for control by regulatory agencies (FDA, EMA) due to potential genotoxicity and carcinogenicity. These impurities can form during synthesis via reactions between secondary amines and nitrosating agents or accumulate under storage conditions. With the implementation of ICH M7, detection and control of such impurities have become critical for drug quality.

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.5 minutes, with LOD of 0.005 ng/mL for trace analysis.
• Formation Mechanism：Originates from nitrosation of the imidazole ring in biotin, with higher reactivity under acidic conditions (pH <3). Adding nitrosamine inhibitors (e.g., ascorbic acid) or optimizing purification (e.g., SPE) reduces content by >80%.
• Safety Evaluation：Preliminary toxicology shows positive Ames test results, indicating potential mutagenicity. Current standards limit it to ≤0.1 ppm, requiring continuous monitoring via accelerated and long-term stability studies.

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!