N-nitroso-N-octylglucamine NEW

N-nitroso-N-octylglucamine

Product Information

• Product Code：N031281

• English Name：N-nitroso-N-octylglucamine

• English Alias：N-octyl-N-((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)nitrous amide

• CAS No.：[Not Available]

• Molecular Formula：C₁₄H₃₀N₂O₆

• Molecular Weight：322.40

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and circular dichroism for structure, suitable for precise analysis of N-nitroso impurities.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile-water solution within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of N-nitroso impurities in meglumine-containing drugs (e.g., contrast agents), controlling content to meet ICH M7 standards (≤1.5 μg/day).

• Process Optimization Research：Monitors N-nitroso-N-octylglucamine formed by nitrosation side reactions during meglumine derivative synthesis or storage, reducing generation by >60% by adjusting reaction temperature (e.g., 5-10℃) and antioxidant dosage.

• Method Validation：Serves as a standard for developing nitrosamine impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3 minutes, with LOD of 0.002 ng/mL for trace nitrosamine analysis.

• Formation Mechanism：Formed by reaction of octyl meglumine with sodium nitrite under acidic conditions (pH<4); optimizing reaction pH (neutral) and avoiding nitrite additives inhibits its formation.

• Safety Evaluation：In vitro Ames tests show mutagenicity; the permitted daily intake (TTC value) is determined as 1.5 μg/day, requiring strict content control. Accelerated stability testing is ongoing to monitor nitrosation rates under different humidity and light conditions.

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!

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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!