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Cetrorelix
References
FAQ's
References
- Andrew V. Schally; Sandor Bajusz, Asta Pharma A.-G., Federal Republic of Germany, “LHRH antagonists” US patent US4800191, Jan 24, 1989
- Manik Reddy Pullagurla, Jagadeesh Babu Rangisetty, Biophore India Pharmaceuticals Private Limited, “Process for the preparation of cetrorelix acetate” US 2019/0382447 Al, Dec.9,2019
Frequently Asked Questions
Why is the synthesis of Cetrorelix impurities essential?
The synthesis of Cetrorelix impurities is essential for the quality control of the drug substance and product. The identification and characterization of impurities help to ensure that the drug is safe and effective for use in patients.
How are Cetrorelix impurities synthesized?
Cetrorelix impurities synthesis involves using the solid-phase peptide synthesis (SPPS) method. The peptide chain is built up by sequentially adding protected amino acid residues, activated by coupling agents, on a solid support resin. After assembling the peptide chain, the protecting groups are removed, and the peptide is cleaved from the resin and purified by chromatography techniques such as RP-HPLC.
How are Cetrorelix impurities detected and quantified?
Cetrorelix impurities are detected and quantified using analytical methods such as high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), etc.
At what temperature should Cetrorelix impurities be stored?
The storage temperature for Cetrorelix impurities may depend on the specific type of impurities and the manufacturer's recommendations. Cetrorelix impurities are stored in a cool, dry place, between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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