Triptorelin Acetate CAS 57773-63-4

Triptorelin Acetate CAS 57773-63-4 | Triptorelin acetate kilogram supply | Non-pharmaceutical filing | Science-Peptide

Triptorelin Acetate CAS 57773-63-4--Supporting generic drug development, microsphere formulation, impurity control studies, Science-Peptide provides high purity Triptorelin Acetate in milligrams to kilograms, with complete structural confirmation, clear impurity profiles, and batch-to-batch stability. This product has not yet been approved for medicinal use and is for research use only. We welcome inquiries.

Triptorelin Acetate CAS 57773-63-4 (Triptorelin acetate), like leuprolide, is a GnRH agonist peptide drug, which is clinically used in the treatment of hormone-dependent diseases such as prostate cancer, breast cancer and endometriosis. It is also a popular species in the domestic generic drug circle, especially its slow-release microsphere formulation, which has been the focus of formulation research and development personnel.

 

We have also invested a lot of years in this variety of Treprostinil. Like leuprolide, our treprostinil is not yet approved for pharmaceutical use and cannot be sold as an API. However, if you are doing pre-generic research, exploring the process of microsphere formulation, or need a large amount of peptide for pilot scale-up, our research-grade products are just right - from milligrams to kilograms, we can provide a stable supply, no need to change suppliers in the middle of the process, and the data can be tracked to the end from the beginning.

Triptorelin (Triptorelin Acetate) is a decapeptide with a structure somewhat similar to that of leuprolide, but the tenth position is Gly-NH₂ instead of ethylamine, and the pharmacokinetic properties are somewhat different. In clinical practice, its long-acting formulations (1-month and 3-month dosage forms) are widely used.

In R&D circles, treprostinil has been targeted for reasons similar to leuprolide:

• Generic drug development: a number of domestic manufacturers in the report, is a classic variety, fierce competition but market stability.
• Microsphere formulation research: Because of the high technological threshold of sustained-release microspheres, treprostinil is often used as a model drug, either for practice or for research.
• Impurity and quality study: Its degradation products and process impurities require high purity controls to match the method and quality control. In particular, its oxidized impurities and missing peptides are the focus of quality studies.

Our Treprostinil 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
A lot of investigational suppliers only do small batches, and when you need tens of grams or hundreds of grams, they just shake their heads. We have also opened up the scale-up process for treprostinil. Now we can provide a stable supply of kilograms of product with controlled purity, impurity profiles, and yields from batch to batch. If you are doing pilot testing of microsphere formulations, or are ready to run three validation batches, you don't have to worry about 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 treprostinil, we keep the data of nuclear magnetic resonance (NMR), infrared resonance (IR) and high resolution mass spectrometry (HRMS). If you need it, 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 all kinds of impurities of Triptorelin for method validation, we can provide single impurity control, the purity is usually >95%, also with structure confirmation data. Oxidized impurities, deamidated impurities, missing peptides are all common impurities, and special impurities can be customized.

Story 1: A university laboratory, microsphere formulation research
They are doing research on the release mechanism of treprostinil microspheres and need a large amount of peptide to run the process parameters. They had previously found a supplier, but after supplying only a few grams, they said they could not do it. When they found us, we directly supplied 500 grams of treprostinil, with purity of 99% or more, in three batches. They used this batch of peptide to complete the whole pilot study, and later published a good article, mentioning us in the acknowledgement.

Story 2: Domestic drug companies, generic impurity studies
They wanted to submit a generic version of treprostinil, but lacked several key impurities as controls. We synthesized five impurities for them, including oxidized impurities and missing peptides, with purity of over 95%, accompanied by NMR and MS confirmatory data. They directly used these data to build a method, and the impurity part passed the approval in the filing.

Story 3: CRO, consistency evaluation program
They took over a consistency assessment project of treprostinil, which required multiple batches of peptide for prescription screening and stability investigation. We supplied three consecutive batches of kilograms of Triprolidine, with COA and impurity profile data for each batch. The project manager said, "The consistency between batches is very good, and the impurity profile is stable, which saves us a lot of efforts of repeated verification."

We have been working on this species for quite a few 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 treprostinil, welcome to talk to us.