Standalix develops and supplies high-purity reference standards designed to meet the evolving needs of pharmaceutical research, quality control, and regulatory compliance. Our core product lines include impurity standards and nitrosamine standards, both carefully characterized to ensure reliability, traceability, and suitability for even the most demanding analytical applications.
Impurity standards:
Our impurity standards are developed to support rigorous analytical control across all stages of pharmaceutical drugs development. These materials enable the detection, identification, and quantification of related substances, degradation products, and residual impurities, ensuring the integrity and safety of drug substances and finished products.
Manufactured under strict quality conditions, each standard is accompanied by a comprehensive Certificate of Analysis, including purity, structure confirmation, and full traceability documentation. Standalix impurity standards are widely used in method development, stability testing, specification setting, and ICH-compliant validation, making them a reliable tool for QC laboratories and regulatory submissions.
Nitrosamine standards:
Nitrosamines are a class of organic compounds with the general structure R₂N–N=O, where R is typically an alkyl group. They contain a nitroso functional group (NO⁺) bonded to a deprotonated amine, and are known for their potential carcinogenicity, particularly in non-human animals. Due to their possible formation as impurities during pharmaceutical manufacturing, they have become a major focus for regulatory authorities worldwide.
At Standalix, we offer a growing selection of nitrosamine reference standards developed to support the detection and quantification of these contaminants in active pharmaceutical ingredients and finished products. Our materials are aligned with the latest guidelines from the EMA, FDA, and ICH M7, and are suitable for use in risk assessments, routine testing protocols, and regulatory submissions.