N-Nitroso Granisetron EP Impurity C NEW

N-Nitroso Granisetron EP Impurity C

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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• Product Information

• Product Number: G006020

• English Name: N-Nitroso Granisetron EP Impurity C

• English Alias: 1-methyl-N-((1R,3r,5S)-9-nitroso-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide

• CAS Number: None

• Molecular Formula: C₁₇H₂₁N₅O₂

• Molecular Weight: 327.38

• Advantages

• As a European Pharmacopoeia (EP) nitroso impurity of Granisetron, this compound has the following advantages:
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• Well-defined and distinct structure: Contains 9-nitroso-9-azabicyclo[3.3.1]nonane ring and 1-methylindazole-3-carboxamide group, differing from Granisetron by nitroso (-NO) substitution on the azabicyclic amine. It can be accurately distinguished by techniques such as HPLC and LC-MS, providing a specific marker for impurity detection;

• High stability and traceability: The conjugated structure of nitroso group and azabicyclic ring is relatively stable under neutral conditions. As a product of nitrosation during Granisetron storage, it directly reflects the degree of deterioration, improving the accuracy of quality tracing;

• High detection sensitivity: The conjugated system of indazole and nitroso groups shows characteristic UV absorption (240-260nm), and combined with specific mass spectral response, trace analysis can be achieved via LC-MS, compatible with heterocyclic drug detection systems.

• Applications

• Pharmaceutical quality control: Used as an EP standard impurity reference to identify and quantify N-Nitroso Granisetron EP Impurity C in Granisetron APIs and formulations, ensuring residual nitroso impurities meet EP requirements;

• Stability evaluation: Assessing the stability of Granisetron formulations under light and high temperature by monitoring impurity content, supporting the development of appropriate storage conditions;

• Impurity profile enhancement: Contributing to the improvement of Granisetron's impurity profile, providing key data for comprehensive evaluation of drug purity and potential safety risks.

• Background Description

• Granisetron is a 5-HT3 receptor antagonist used to prevent chemotherapy-induced nausea and vomiting, with a structure containing 9-azabicyclo[3.3.1]nonane ring. During storage (especially when exposed to nitrites or acidic environments), the amino group on the azabicyclic ring may undergo nitrosation to form a 9-nitroso-substituted derivative, namely N-Nitroso Granisetron EP Impurity C. Nitrosamines are potentially genotoxic and listed as controlled specific impurities in the European Pharmacopoeia, making their control critical for Granisetron quality assurance.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using UPLC-MS/MS with optimized parameters based on characteristic fragment ions of nitroso groups (e.g., NO⁺) to achieve trace detection (detection limits up to ppb level);

• Nitrosation kinetics: Studying impurity formation rates under varying pH and nitrite concentrations to clarify key factors driving azabicyclic amine nitrosation in Granisetron;

• Toxicological assessment: Evaluating genotoxic potential via in vitro assays to establish strict impurity limits;

• Stabilization strategies: Developing anti-nitrosation formulations (e.g., adding reducing agents) and packaging materials to minimize impurity formation in Granisetron products.

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 17386083646
E-mail: anna@molcoo.com