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：C₁₀H₁₅N₃O₄S
Molecular Weight：273.31
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.
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.
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.
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.
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
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!
China
