Buserelin Acetate API
H-4224-GMP, 4038785
Regulatory Documentation
DMF
CAS-Number
57982-77-1 (net), 68630-75-1 (acetate)
Synonyms
(Des-Gly10,D-Ser(tBu)6,Pro-NHEt9)-LHRH
Sequence
Pyr-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-NHEt
acetate salt
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What is buserelin?
Buserelin is a synthetic analogue of gonadotropin-releasing hormone (GnRH). It plays a pivotal role in the regulation of pituitary gonadotropin secretion, directly influencing the production of sex hormones. This makes it an essential tool in various therapeutic applications related to hormonal regulation.
Buserelin acetate mechanism of action
Buserelin functions similarly to other GnRH analogues, such as Leuprolide, Goserelin, and Triporelin. It acts by initially stimulating the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which act as messengers to signal the testes in males and ovaries in females to produce sex hormones such as testosterone and oestradiol. Over time, continuous administration results in a downregulation of GnRH receptors in the pituitary gland, leading to decreased production of sex hormones. This mechanism is effective in controlling hormone-sensitive conditions.
What is buserelin used for?
Buserelin acetate has several key therapeutic uses, owing to its ability to regulate hormone levels with precision. In fertility treatments, buserelin is used to control ovulation and prepare the endometrium for pregnancy, optimising the chances of conception. Other uses include the management of hormone-sensitive cancers, notably prostate cancer, where it suppresses hormone levels that contribute to tumour growth, providing a critical therapy for those in need.
Buserelin is also valuable in treating endometriosis and uterine fibroids, conditions that are often driven by hormonal imbalances. By reducing the production of sex hormones that aggravate these conditions, buserelin offers relief and improves quality of life. Plus, it’s used in pre-surgical scenarios to shrink fibroids, making surgical interventions less invasive and reducing recovery times. This broad spectrum of uses highlights buserelin’s versatility and effectiveness in addressing hormone-relating conditions.
Why choose Bachem as your buserelin API manufacturer?
Choosing Bachem for your Buserelin Acetate API needs ensures access to a world leader in peptide technology with a proven track record of excellence. Our advanced manufacturing capabilities guarantee high-yield and consistent batch-to-batch production, ensuring your supply chain remains uninterrupted.
Bachem’s commitment to quality and compliance is unmatched in the industry, providing customers with GMP-certified products and comprehensive regulatory support. Opt for Bachem and experience seamless procurement through our streamlined customer service and flexible order quantities.
Understanding the critical roles of timing, regulatory compliance, and quality in your success, we have designed our services to align with these priorities. Our commitment is to offer customer-focused services that enhance and strengthen your processes.
Our clients benefit from fast shipping due to our well-stocked inventory, expedited registration supported by readily accessible Drug Master Files (DMFs) and Certificates of Suitability, the monographs of the European Pharmacopoeia (CEPs), and a thorough impurity management service.
How do we ensure an optimised and high-yield production?
At Bachem, our production process for Buserelin Acetate is designed to maximise yield and ensure product integrity through Low-temperature Peptide Synthesis (LPPS) and synergies within the synthesis of our “relin” product line. This method allows for the preservation of peptide bonds and structures, crucial for the API’s efficacy and stability. By leveraging our extensive experience and integrated production chains, we optimise every step of the synthesis process, making sure our clients receive the highest quality products.
Our capabilities span from small-scale to industrial-level production of generic active pharmaceutical ingredients (APIs). We have the capacity to fulfil orders ranging from grams to multi-kilogram, or even tens of tons, with reliable and timely delivery. By manufacturing starting materials in-house, we ensure a secure and sustainable supply chain.
Innovation is at the core of our operations. We are driven to continuously optimise our processes, quality standards, and efficiency. We actively explore and adopt cutting-edge technologies to capitalise on emerging opportunities in the generic API market. This allows us to maintain high quality, minimise lead times, and ensure cost-effectiveness for our customers.
Related generic APIs and services
Explore our range of related APIs, including those with available impurities and validated dossiers. Bachem is your trusted partner for petite API solutions.
Fields of Application
Use in reproduction medicine
Advanced hormone-dependent prostate cancer
Endometriosis
Central precocious puberty
Uterine myoma
Active Substance
Buserelin is a potent LHRH (GnRH) agonist. After a transient increase, continuous administration of buserelin results in downregulation of LH and FSH levels followed by a suppression of ovarian and testicular steroid biosynthesis.
Molecular Information
Molecular Formula
C60H86N16O13
Relative Molecular Mass
1239.44 g/mol
CAS-Number
57982-77-1 (net), 68630-75-1 (acetate)
Long-term Storage
-20 ± 5 °C
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