Leuprorelin impurity
Time:2025-02-27
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Leuprorelin is a synthetic analog of gonadotropin-releasing hormone (GnRH), which reduces sex hormone levels by inhibiting the function of the pituitary-gonadal axis, and is mainly used in the treatment of prostate cancer and uterine fibroids.
Takeda Pharmaceutical‘s leuprolide extended-release microsphere injection (trade name “Lupron”) was approved in 1989, and currently covers the global market.
In 2025, Changchun Jinsai Pharmaceutical cooperated with Yida Bio to launch leuprolide injectable emulsion (Camcevi) in China, which is a 6-month long-acting, prefilled subcutaneous formulation, significantly improving the convenience of medication and realizing a breakthrough in the new dosage form of leuprolide.
Leuprolide, as a peptide drug, has continuous iteration in clinical application and formulation technology, and impurity study is the core link to ensure efficacy and safety.SZEB focuses on providing high-purity and high-accuracy leuprolide impurity reference , covering 20+ key impurities from synthetic intermediates to degradation products, for use in method development and mandatory degradation experiments, and to accelerate the ANDA filing of generic drugs.
SZEB is able to respond quickly to common challenges in sourcing leuprolide impurities, providing technical guidance such as HPLC assay solutions and regulatory counseling, and customers can obtain a customized impurity sourcing solution through online consultation. Below is a partial catalog of Leuprolide impurities. Customized COAs (Certificates of Analysis) and more information can be found on the Leuprolide impurities product page in the offical website:www.ex-techbio.com .
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