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Aquigen Bio Expands Its Impurity Standards Portfolio with High-Quality Nicotine Impurities for Advanced Research and Pharmaceutical Development

06-30-2025 11:04 AM CET | Chemicals & Materials

Press release from: Aquigen Bio Sciences

Aquigen Bio Expands Its Impurity Standards Portfolio with

Aquigen Bio, a trusted name in the pharmaceutical reference standard industry, is proud to announce the expansion of its Nicotine Impurity Standards category. This strategic addition includes a specialized range of nicotine-related impurities such as Nicotine Nitroso Impurity 1, Nicotine EP Impurity A, Nicotine Impurity 1, and Nicotine Impurity 3, catering to the stringent needs of the global pharmaceutical, research, and testing communities.
https://aquigenbio.com/products/impurity-standards/nicotine/

Nicotine and its derivatives are commonly studied compounds, particularly in the development and quality control of nicotine-containing products, including smoking cessation aids and e-cigarette formulations. As regulatory agencies such as the US FDA, EMA, and WHO demand higher safety profiles and accurate impurity profiling, the need for reliable impurity reference standards has never been greater.

Precision and Purity for Analytical Excellence
Aquigen's Nicotine Impurity Standards are manufactured and tested to meet international pharmacopoeial requirements, including EP, USP, and ICH guidelines. With a focus on quality, consistency, and purity, each impurity standard undergoes rigorous quality control protocols using advanced analytical techniques such as NMR, MS, and HPLC.

Among the newly listed nicotine impurity standards:
🔹 Nicotine Nitroso Impurity 1
https://aquigenbio.com/product/nicotine-nitroso-impurity-1/
This impurity is critical in carcinogenicity studies and genotoxic impurity profiling, especially for manufacturers working on nicotine APIs or dosage formulations.

🔹 Nicotine EP Impurity A
https://aquigenbio.com/product/nicotine-ep-impurity-a/
Listed in the European Pharmacopoeia, this impurity is essential for regulatory submissions and quality benchmarking of nicotine-containing medicinal products.

🔹 Nicotine Impurity 1
https://aquigenbio.com/product/nicotine-impurity-1/
Used extensively in routine impurity profiling and method validation studies, offering reliable data in stability and shelf-life assessments.

🔹 Nicotine Impurity 3
https://aquigenbio.com/product/nicotine-impurity-3/
Supports analytical development and batch consistency evaluation, assisting pharmaceutical companies in remaining compliant with global standards.

Why Choose Aquigen Bio?
Aquigen Bio has positioned itself as a premier partner for pharmaceutical impurity standards. Its vertically integrated manufacturing, quality-centric approach, and customer-focused support ensure rapid delivery and reliable results. Each standard is shipped with a Certificate of Analysis (CoA), Safety Data Sheet (SDS), and full characterization data.

"Our nicotine impurity standards are a reflection of Aquigen's dedication to scientific accuracy, regulatory compliance, and the pharmaceutical community's evolving needs," said a spokesperson for Aquigen Bio. "We believe in making high-quality impurity standards accessible to researchers and manufacturers worldwide."

Available Globally
Aquigen Bio Nicotine Impurity Standards are now available for global delivery, serving R&D labs, CROs, generics manufacturers, and regulatory submission teams across continents. With a robust logistic framework and responsive customer support, Aquigen ensures timely assistance for bulk requirements, documentation, and technical inquiries.

Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Visit: www.aquigenbio.com

Aquigen Bio Sciences stands as India's premier resource for high-quality N-Nitroso impurity standards, impelling advancements in pharmaceutical research and manufacturing. Specializing in providing precise impurity standards - including degradation impurities, process impurities, and deuterated isotopes - Aquigen Bio Sciences empowers the industry to comply with the most rigorous global regulations. The contract research organization's commitment to precision and reliability makes it the trusted partner for addressing complex issues like N-Nitroso impurities in pharmaceuticals.

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