High-Purity N-Nitroso Betahistine D3 for Precise Pharmaceutical Analysis | Deuterated Nitrosamine Impurity Standard for Method Development, Validation, Quality Control, and Regulatory Submissions in Betahistine Impurity Profiling and Research

Product Overview
N-Nitroso Betahistine D3 is a premium deuterated nitrosamine impurity standard, specifically developed for precise analytical testing in pharmaceutical laboratories. This reference standard is widely used for analytical method development, validation, and quality control processes to meet stringent regulatory guidelines. With exceptional purity, complete documentation, and reliable traceability, it is ideal for research, development, and compliance applications.

https://aquigenbio.com/product/n-nitroso-betahistine-d3/

Key Features and Benefits
Deuterated Design for Precision: The incorporation of deuterium improves mass spectrometric detection, providing enhanced sensitivity and accurate quantification.

Regulatory Support: Complies with global pharmacopeial standards and is suitable for analytical method validation, quality control, and ANDA submissions.

Rapid Dispatch: Available in stock to support urgent project timelines with prompt 24-hour dispatch.

High Purity and Stability: Manufactured under stringent quality processes to ensure reliable, reproducible results in critical analyses.

Comprehensive Documentation: Supplied with a Certificate of Analysis (COA) and Safety Data Sheet (SDS) for traceability and compliance.

Applications
N-Nitroso Betahistine D3 is extensively used in pharmaceutical and analytical research, particularly in:
Analytical method development and validation
Routine quality control testing
Impurity profiling in drug substances and formulations
Regulatory submissions, including ANDA and DMF filings
Stability studies and toxicological evaluations

This reference standard is intended for laboratory analytical use only and is not for human consumption.

Safety and Handling Guidelines
Laboratory safety is critical when working with nitrosamine standards. Follow these safety protocols to ensure safe handling:
Review the Safety Data Sheet (SDS) thoroughly before use.

Explore Betahistine Impurities
https://aquigenbio.com/products/impurity-standards/betahistine/

Always wear appropriate personal protective equipment (PPE), including safety goggles, gloves, and lab coats.

Handle in a well-ventilated area or fume hood to avoid inhalation of vapors or dust.

Ensure proper labeling and storage to prevent contamination and accidental exposure.

Keep emergency equipment, such as eyewash stations and spill kits, readily accessible.

Follow approved procedures for chemical waste disposal in compliance with local regulations.

Clean reusable equipment after handling, and remove contaminated clothing immediately.

Adhering to these safety measures helps maintain a safe laboratory environment and ensures consistent quality in analytical work.

Why Choose N-Nitroso Betahistine D3

Selecting the right impurity standard is crucial for achieving reliable analytical outcomes. N-Nitroso Betahistine D3 is backed by rigorous quality control and traceability processes, ensuring confidence in every application. Its deuterated design improves analytical performance in LC-MS and GC-MS workflows, making it an indispensable choice for laboratories working on precise impurity profiling or regulatory submissions.
With prompt global shipping and expert technical support, Aquigen Bio ensures that researchers and analysts can access high-quality reference materials when they need them most.

Category Reference
N-Nitroso Betahistine D3 is part of the Betahistine impurity standards range, designed to support analytical requirements across different stages of drug development. This category includes a comprehensive portfolio of Betahistine-related impurities and derivatives, ensuring a one-stop solution for pharmaceutical R&D and quality control laboratories.

Related Products
Betahistine EP Impurity A

https://aquigenbio.com/product/betahistine-ep-impurity-a/

Betahistine EP Impurity A, also known as 2-Vinylpyridine, is an essential reference standard used for analytical testing and method validation. With high purity and well-documented analytical data, it is suitable for trace impurity profiling, stability studies, and regulatory submissions. This compound is strictly intended for laboratory use only and is supplied with full documentation to support compliance and traceability.

Betahistine Dihydrochloride

https://aquigenbio.com/product/betahistine-dihydrochloride/

Betahistine Dihydrochloride is another key reference material for pharmaceutical analysis. It is widely used in method development, quality control, and ANDA or DMF filing processes. Produced under stringent quality standards, this compound ensures reproducibility and accuracy in analytical workflows. Like all Aquigen Bio products, it is intended exclusively for research and analytical purposes and is not for human use.

Technical and Analytical Advantages
N-Nitroso Betahistine D3 offers several technical advantages that make it a preferred choice for advanced laboratories:
Enhanced Sensitivity in Detection: The deuterium labeling aids in achieving lower detection limits in LC-MS and GC-MS methods.

Improved Traceability: Each batch is fully characterized with spectral data and purity confirmation, ensuring consistent quality.

Compatibility with Multiple Platforms: Suitable for various analytical techniques, including HPLC, LC-MS, GC-MS, and NMR

Regulatory Alignment: Developed to support compliance with ICH, USP, and EP guidelines for impurity standards.

Commitment to Quality and Compliance
Every batch of N-Nitroso Betahistine D3 undergoes rigorous testing for purity, identity, and stability. Detailed analytical data, including mass spectrometric profiles and chromatographic purity, are provided in the COA. This ensures confidence in reproducibility and accuracy, which is vital for regulatory audits and submission dossiers.

Ordering and Support
N-Nitroso Betahistine D3 is available in various pack sizes to meet different research and analytical requirements. With efficient logistics, orders are processed and dispatched within 24 hours to minimize downtime in ongoing projects. Technical support is available to help with product selection, analytical method compatibility, and documentation needs.

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Bio Sciences
Aquigen Bio Sciences is at the forefront of pharmaceutical excellence, serving as the leading resource for Betahistine impurity standards in India. With a strong commitment to safety, innovation, and regulatory compliance, the organization specializes in impurity profiling, synthesis, and analysis, empowering pharmaceutical manufacturers globally with premier standards. Aquigen Bio Sciences' dedication to cutting-edge research ensures it remains a trusted partner in refining quality benchmarks across the pharmaceutical landscape.

This release was published on openPR.