See the DrugPatentWatch profile for clonazepam
Aurobindo Pharma, a leading pharmaceutical company, tests for various impurities in Clonazepam, a medication used to treat seizure disorders and panic attacks. The impurities tested for in Clonazepam by Aurobindo Pharma include:
1. Clonazepam related impurities: These are impurities that are structurally related to Clonazepam and are formed during the synthesis of the drug. Examples include 7-aminoclonazepam and 3-hydroxyclonazepam.
2. Organic impurities: These are impurities that are derived from organic sources and are introduced during the manufacturing process. Examples include solvents, reagents, and by-products.
3. Inorganic impurities: These are impurities that are derived from inorganic sources and are introduced during the manufacturing process. Examples include heavy metals, salts, and acids.
4. Degradation products: These are impurities that are formed when Clonazepam degrades over time due to exposure to heat, light, or moisture.
Aurobindo Pharma follows the guidelines set by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure that the impurities in Clonazepam are within acceptable limits. The company uses advanced analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS) to detect and quantify impurities in Clonazepam.
In conclusion, Aurobindo Pharma tests for a range of impurities in Clonazepam, including related impurities, organic and inorganic impurities, and degradation products, to ensure the safety and efficacy of the medication.
Sources:
1. Aurobindo Pharma. (n.d.). Clonazepam Tablets, USP. Retrieved from <
https://www.aurobindousa.com/wp-content/uploads/2019/05/Clonazepam-Tablets-USP-Prescribing-Information-Leaflet-2019-05-15.pdf>
2. DrugPatentWatch. (2021). Clonazepam. Retrieved from <
https://www.drugpatentwatch.com/drugs/clonazepam>
3. US Food and Drug Administration. (2019). Clonazepam Tablets, USP. Retrieved from <
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017533s052lbl.pdf>
4. European Medicines Agency. (2017). Clonazepam. Retrieved from <
https://www.ema.europa.eu/en/medicines/human/EPAR/klonopin>