Goserelin Acetate CAS 145781-92-6

Goserelin Acetate CAS 145781-92-6 | Goserelin acetate Kg supply | Science-Peptide

Goserelin Acetate CAS 145781-92-6 research grade peptide - support implant process development, generic research, impurity controls. Goserelin Acetate is available in grams to kilograms of high purity, with complete structural confirmation, clear impurity profiles, and lot-to-lot stability. This product has not yet passed the record of medicinal use, and is only for research use. Welcome to contact us.

Goserelin (goserelin acetate) is another important member of the GnRH agonist family. Unlike leuprolide and treprostinil, goserelin is best known in the clinic for its extended-release implant - a small rod that is buried under the skin and released slowly over a three-month period. The technological threshold for this dosage form is even higher than that for microspheres, so many of the people who make generic versions of goserelin do so for the implant.

 

We have also invested a lot of efforts in the variety of Goserelin. Like leuprolide and treprostinil, our goserelin has not yet been filed for pharmaceutical use and cannot be sold as an API. However, if you are doing process development for implantation, pre-research for generic drugs, or need a large amount of peptide for pilot scale-up, then our research-grade products are just right - from grams to kilograms, we can provide a stable supply, without changing suppliers in the middle, and the data can be tracked to the end from the beginning.

Goserelin (Goserelin Acetate) is a decapeptide whose tenth position is AzGly (azaglycine), a structure not found in natural amino acids, which was introduced artificially, mainly to enhance metabolic stability. The implant (Zoladex) is the main dosage form and is available in two sizes: 1 month and 3 months.

In R&D circles, goserelin has received less attention than other GnRH agonists:

• Implant development: Because the implant process is more complex than microspheres, the requirements for APIs are also higher - batch-to-batch consistency, impurity profile stability, solubility and these indicators directly affect the release profile of the implant.
• Generic research: domestic manufacturers to do goserelin generic relatively few, but the competitive landscape is clearer, the first generic opportunity is still there.
• Impurities and quality study: Its AzGly site and tert-butyl protecting group will introduce some special degradation products and process impurities, and the synthesis and characterization of these impurities are the difficulties in the quality study.

Our goserelin is positioned to support these R&D scenarios - not for clinical supply, but definitely enough for R&D, and it can be picked up from milligrams to kilograms.

1. Kilogram capacity for implant process development
The process development of implantable agents has a great demand for APIs. A pilot test may require tens of grams or even hundreds of grams, and after three batches of validation, several hundred grams will go out. In Goserelin, we have also opened up the scale-up process, and we can stably supply kilograms of product with controlled purity, impurity profile, and yield between batches. If you are doing the pilot test of implantable agent, you don't need to worry about the raw material anymore.

2. AzGly site, we're familiar with it
The 10th position of Goserelin is AzGly (azaglycine), which is not a standard amino acid and needs to be synthesized with special raw materials. We have done a lot of peptides with AzGly, and we know its coupling conditions and stability, so we won't get stuck at this position. The purity of regular products is ≥98%, and the key items can be ≥99% or more.

3. The impurity spectrum is clear, and special impurities can be controlled
There are several specific impurities in the impurity profile of Goserelin: degradation products associated with the AzGly site, impurities from tert-butyl shedding, and dimers. We have done systematic analysis and can provide a complete list of impurities and controls. If you need these special impurities to match your method, we can also customize them.

Story 1: A biotech company, pilot scale-up of an implant
They were developing a goserelin implant and needed kilograms of API to run three pilot batches. The supplier they had previously found was unable to do so after supplying only a few dozen grams. They found us, and we directly supplied 1 kilogram of Goserelin with 99.2% purity in three batches. They used this batch of peptide to complete the pilot test, the release curve is stable, and then smoothly into the official batch production. The project leader said, "The implant is most afraid of raw material fluctuation, your three batches of data are exactly the same, we are relieved."

Story 2: Domestic drug companies,AzGly impurity study
They reported a generic version of Goserelin, and found that it was difficult to get the control for several impurities related to the AzGly site. We helped them synthesize three AzGly-related impurities with purity over 95%, with NMR and MS confirmation data. They used these impurities to build a method, and the impurity part of the application was successfully approved.

Story 3: College pharmacy laboratory, implant release mechanism study
They were studying the release kinetics of goserelin implant and needed peptides of different purity levels for comparison. We provided two specifications of crude peptide (>80%) and high purity peptide (>99%), and helped them to complete the study of release mechanism. The paper was published in a major journal in the field of pharmacology, and we were included in the acknowledgement.

We have been working on this variety of Goserelin for many years, from small trials to kilograms. Especially for AzGly, we have rich experience in synthesizing this special site, and we also have a good understanding of the impurity profile. If you are doing implant development or generic research, and need stable, complete data, and research-grade goserelin that can be supplied in small to large quantities, please feel free to talk to us.