N‐Nitroso Methylphenidate D3: A Critical Reference Standard in Pharmaceutical Analysis - Rude0214851/Blog GitHub Wiki

In the realm of pharmaceutical research and quality control, the identification and quantification of impurities are paramount. Among these impurities, nitrosamines have garnered significant attention due to their potential carcinogenic properties. One such compound of interest is N-Nitroso Methylphenidate D3, a deuterated analog of N-Nitroso Methylphenidate. This article delves into the significance of N-Nitroso Methylphenidate D3, its applications, and its role in ensuring drug safety and efficacy.​

Understanding N-Nitroso Methylphenidate D3 Chemical Profile:

Chemical Name: Methyl-d3 (R)-2-((R)-1-nitrosopiperidin-2-yl)-2-phenylacetate​ Molecular Formula: C14H15D3N2O3​ Molecular Weight: 265.3 g/mol​ CAS Number: Not assigned​ N-Nitroso Methylphenidate D3 is a stable isotope-labeled compound, where three hydrogen atoms are replaced with deuterium. This modification makes it an ideal internal standard for mass spectrometric analyses, allowing for precise quantification of N-Nitroso Methylphenidate in various matrices.

The Emergence of Nitrosamine Impurities in Pharmaceuticals Nitrosamines are a class of compounds characterized by the presence of the nitroso functional group attached to an amine. Their potential carcinogenicity has led regulatory agencies worldwide to mandate stringent controls on their presence in pharmaceuticals.​

Regulatory Landscape:

Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established acceptable intake limits for various nitrosamines. These regulations necessitate the development of sensitive and specific analytical methods to detect and quantify nitrosamine impurities, including N-Nitroso Methylphenidate.​

Analytical Applications of N-Nitroso Methylphenidate D3

  1. Method Development and Validation

In the development of analytical methods, particularly those involving liquid chromatography-tandem mass spectrometry (LC-MS/MS), N-Nitroso Methylphenidate D3 serves as an internal standard. Its structural similarity to N-Nitroso Methylphenidate ensures comparable behavior during chromatographic separation and ionization, while its distinct mass allows for differentiation during detection.​

  1. Quality Control and Batch Release Testing

Pharmaceutical manufacturers utilize N-Nitroso Methylphenidate D3 in quality control laboratories to monitor nitrosamine levels in methylphenidate-containing products. By incorporating this internal standard, laboratories can achieve accurate quantification, ensuring that nitrosamine levels remain within regulatory limits.​

  1. Stability Studies

Stability studies assess the propensity of methylphenidate formulations to form nitrosamines over time. N-Nitroso Methylphenidate D3 aids in these studies by providing a reliable reference point for quantification, enabling researchers to evaluate the effectiveness of formulation strategies aimed at minimizing nitrosamine formation.​

AquigenBio’s Commitment to Quality and Innovation At AquigenBio, we recognize the critical role that reference standards play in pharmaceutical analysis. Our N-Nitroso Methylphenidate D3 is synthesized under stringent quality control measures, ensuring high purity and consistent performance.​

Product Specifications:

Storage Conditions: 2–8°C for long-term storage​ Shipping Conditions: Stable at room temperature during transit​ By providing high-quality reference standards, AquigenBio supports pharmaceutical companies and research institutions in their efforts to ensure drug safety and compliance with regulatory standards.