Nitroso Compounds - NDSRI's
References
FAQ's
Frequently Asked Questions
Why are Nitroso Compounds Impurities a concern?
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.
How are Nitroso Compounds Impurities controlled?
Strict quality control measures help during the manufacturing process of Nitroso compounds. Regulatory authorities set specific limits for impurity levels of compounds.
Can Nitroso Compounds Impurities impact generic versions?
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.
What are the temperature conditions required to store Nitroso Compounds Impurities?
Nitroso compound impurities are kept at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).
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