Press release
Tizanidine Nitroso Impurity 1 - High-Purity Reference Standard for Reliable Impurity Profiling, Regulatory Compliance, and Safer Tizanidine Drug Development | Aquigen Bio Nitroso Impurity Standards
At Aquigen Bio, we are proud to offer Tizanidine Nitroso Impurity 1, a high-purity reference standard meticulously synthesized and validated to meet the rigorous demands of pharmaceutical quality control, analytical method development, and regulatory filing processes.
What is Tizanidine Nitroso Impurity 1?
https://aquigenbio.com/product/tizanidine-nitroso-impurity-1/
Tizanidine is a centrally acting α2-adrenergic agonist commonly prescribed as a muscle relaxant to treat conditions like multiple sclerosis and spinal cord injuries. During the synthesis or degradation of the Tizanidine active pharmaceutical ingredient (API), nitroso impurities may be formed, either through unintended reactions or environmental exposure.
Tizanidine Nitroso Impurity 1 is one such potential impurity that must be identified, monitored, and controlled as per international guidelines (ICH M7, Q3A, Q3B). Nitroso compounds are under heightened scrutiny due to their potential genotoxicity and carcinogenic risk. As a result, the ability to detect even trace amounts of Nitroso Impurity 1 is essential during pharmaceutical development and batch release.
Why Tizanidine Nitroso Impurity 1 Matters in Drug Safety
The importance of Tizanidine Nitroso Impurity 1 is rooted in its impact on patient safety and drug approval:
Regulatory Compliance: Regulatory bodies like the USFDA, EMA, and CDSCO now mandate stringent control of nitrosamine-related impurities. Tizanidine Nitroso Impurity 1 falls within this category.
Risk Assessment & Mitigation: Its inclusion in risk assessments allows pharmaceutical manufacturers to confidently demonstrate product safety.
Explore Nitroso Impurities
https://aquigenbio.com/products/impurity-standards/nitroso/
Analytical Method Development: With the availability of certified reference standards, QC teams can develop and validate accurate testing methods for routine batch analysis.
The availability of high-purity, well-characterized impurity standards from reliable sources such as Aquigen Bio enables seamless regulatory submissions and improves the overall safety profile of the pharmaceutical product.
Aquigen Bio: Trusted Partner for Nitroso Impurity Standards
At Aquigen Bio, we understand that access to certified impurity standards is critical to the drug development lifecycle. Our extensive range of nitroso impurities includes:
Tizanidine Nitroso Impurity 1
Tizanidine Nitroso Impurity 2
Tizanidine Nitroso Impurity 3
https://aquigenbio.com/product/tizanidine-nitroso-impurity-3/
These are part of our broader Nitroso Impurity Standards category, specially curated to meet industry needs for genotoxic impurity profiling.
Each of our impurity products undergoes:
Analytical characterization via NMR, IR, Mass, and HPLC.
Certificate of Analysis (CoA) with traceable documentation.
Batch-to-batch consistency to support long-term research needs.
Custom pack sizes and prompt global shipping to support urgent R&D timelines.
Applications of Tizanidine Nitroso Impurity 1 in Pharma R&D
Analytical Method Development & Validation
Impurity 1 serves as a reference for developing stability-indicating methods, validating HPLC/LC-MS techniques, and preparing calibration curves for quantification.
Stability Studies
During forced degradation or accelerated stability studies, the detection of Tizanidine Nitroso Impurity 1 helps determine degradation pathways and product shelf-life.
Regulatory Submissions
ICH guidelines require full disclosure and documentation of all potential nitroso impurities in APIs. Having a validated standard like Tizanidine Nitroso Impurity 1 ensures data accuracy and regulatory readiness.
Toxicological Evaluation
In silico and in vitro studies require well-characterized impurities to assess their genotoxicity potential - vital for justifying permitted daily exposure (PDE) limits.
Why Choose Aquigen Bio?
Aquigen Bio is a pioneer in supplying high-purity pharmaceutical impurity reference standards to leading manufacturers and CROs worldwide. Our R&D scientists and analytical chemists follow strict quality protocols to deliver reliable standards that support:
Faster drug development timelines
Regulatory risk mitigation
Cost-effective and reproducible impurity profiling
Our customers appreciate the transparency of our analytical reports, responsiveness to technical queries, and a robust logistics framework that ensures timely delivery in compliance with global transport regulations.
Additional Tizanidine Nitroso Impurities Available
Along with Impurity 1, Aquigen Bio also offers:
Tizanidine Nitroso Impurity 2:
https://aquigenbio.com/product/tizanidine-nitroso-impurity-2/
Ideal for orthogonal method development and related substance analysis.
Tizanidine Nitroso Impurity 3: Useful for confirming degradation patterns under various stress conditions.
Together, these standards offer a comprehensive impurity profiling toolkit for your Tizanidine projects.
Global Delivery & Custom Orders
Whether you are conducting early-stage R&D or preparing for regulatory submission, Aquigen Bio can support your needs with:
Custom synthesis of rare impurities
Flexible pack sizes
Secure packaging and fast global delivery
Dedicated customer support for documentation and technical questions
Our team ensures that your lab gets the exact material you need - with full traceability and compliance assurance.
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 Gefitinib 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.
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