Leuprolide Acetate CAS 1926163-25-8

Leuprolide Acetate CAS 1926163-25-8 | Leuprorelin acetate Kg supply | Science-Peptide

Leuprolide--Supporting generic drug development, microsphere formulation, impurity studies, Science-Peptide offers high purity Leuprolide Acetate in grams to kilograms, with complete structural confirmation, clear impurity profiles, and lot-to-lot stability. This product has not yet been approved for medicinal use and is for research use only. We welcome inquiries.

Do leuprolide R & D people, more or less have encountered such an embarrassment: small trials to find some peptide easy, to the pilot scale-up, the original supplier said that can not do so large quantities, or the quality of the batch drifted too much, impurity profiles can not be matched, the process is not yet run out of the source will have to be changed. We have been grinding on this species for more than ten years, from milligrams to kilograms of production capacity are through, process stability, impurity profiles clear, full data.

 

To be clear: our leuprolide has not been filed for medicinal use, it can not be sold as an API, nor can it be directly given to human beings. However, if you are doing the pre-study of generic drugs, the process of microsphere formulation, the development of impurity control, or need a large amount of leuprolide to run the pilot test, then our research-grade products are just right for the road - not only can we provide a small trial of a few milligrams, but also can take a few tens of kilograms of large orders, without changing suppliers in the middle.

Leuprolide Acetate CAS 1926163-25-8 (leuprolide acetate) is a 9-peptide, GnRH agonist that is used clinically to treat hormone-dependent diseases such as prostate cancer, breast cancer, and endometriosis. In R&D circles, it has been targeted for three main reasons:

Generic drug development: several domestic manufacturers have reported, is a classic variety.
Microsphere formulation research: Because of the high technical threshold of long-acting formulations, leuprolide is often used as a model drug, either for practice or for research.
Impurity and quality studies: Its degradation products and process impurities require high purity controls for method and quality control.

Our leuprolide 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. Kilograms of capacity, with no change of personnel for pilot scale-up
Many research-grade suppliers only do small quantities, and when you need tens of grams or hundreds of grams, they shake their heads. We are different in leuprolide: small test, pilot test, scale-up, using the same set of process logic. Now we can supply kilograms of product stably, and we can control the purity, impurity profile and yield between batches. If you are doing the pilot test of microsphere formulation, or ready to run three batches for validation, you don't need to worry about the raw materials anymore.

2. Sufficiently pure, with a clear impurity profile
We use solid-phase synthesis, Fmoc strategy, and multi-step preparative HPLC for purification. the purity of regular goods is ≥98%, and the key items can be ≥99% or above. Each batch of COA, with HPLC and MS graphs. For items requiring impurity profiling, we can provide a complete list of known impurities - oxidized impurities, deamidated impurities, missing peptides, dimers - we have the data, and we can also provide controls.

3. Structural corroboration information, ready for use
The lack of structural confirmation data in the submission is a headache for many researchers. When we make leuprolide, we keep the data of nuclear magnetic resonance (NMR), infrared resonance (IR) and high resolution mass spectrometry (HRMS). If you need, we will give you the whole set of data, not a template. Previously, a customer directly attached these data to the declaration documents, the review did not pick up the problem.

4. Impurity controls, which we can match
If you need various impurities of leuprolide for method validation, we can provide single impurity controls with purity >95% and structure confirmation data. Oxidized impurities, deamidated impurities, missing peptides are all common impurities, and special impurities can be customized.

Story 1: A generic drug company, microsphere pilot scale-up
They tried another company's peptide, but when they came to the pilot test, the company said they could not do the kilogram grade. They found us, and we directly provided three batches of leuprolide in kilogram grade according to their requirements, with purity above 99% and impurity profiles similar to that of the other peptide in the small trial. They used these three batches to run the pilot test, the data consistency is very good, and then directly signed a long-term supply agreement. The R&D manager of the other party said, "I am most afraid of changing suppliers, but you can make it from small to big, which saves us a lot of trouble."

Story 2: Domestic drug company research institute, impurity research
They wanted to report a generic version of leuprolide, and lacked several key impurity controls. We synthesized six impurities for them, all of which were more than 95% pure, with NMR and MS confirmation data. They used the data directly in the filing, and the impurity part was passed in one go during the evaluation, and no supplement was issued.

Story 3: College pharmacy labs, long-acting injectable research
They were studying the release mechanism of leuprolide microspheres and needed peptides of different purity levels for comparison. We provided three kinds of peptides: crude peptide (>80%), standard peptide (>98%) and high purity peptide (>99%), and helped them to complete the study of release kinetics. Later, the paper was published in the Journal of Controlled Release, and we were mentioned in the acknowledgement.

We have been working on leuprolide for many years, from small trials to kilograms. If you are doing related research and development, and need stable, complete data, and can be supplied from small to large quantities of research-grade leuprolide, welcome to talk to us.