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Home > NDSRI's > Nitroso Compounds

Nitroso Compounds - NDSRI's

References
FAQ's

References

Ganpisetti Srinivasa Rao,  Dharamasoth Ramadevi,  B. M. Rao,  Nagaraju Rajana,  K. Basavaiah, Novel stability indicating LC-MS method for N-Nitroso dimethyl amine genotoxic impurity quantification in ranitidine drug substance and drug product,  Research Article | Volume: 12, Issue: 7, July, 2022

Frequently Asked Questions

Nitroso Compounds impurities can affect the drug's quality, safety, and efficacy. They may alter the chemical properties, stability, or toxicity leading to adverse effects or reduced effectiveness.

Strict quality control measures help during the manufacturing process of Nitroso compounds. Regulatory authorities set specific limits for impurity levels of compounds.

Generic manufacturers must demonstrate that their products meet the same impurity standards as the branded version. Comparative studies and rigorous quality control ensure that generic versions are equivalent in drug purity, safety, and efficacy.

Nitroso compound impurities are kept at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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