Orforglipron Impurity 20

Orforglipron Impurity 20 is a high‑purity analytical reference standard and key pharmaceutical intermediate supplied by Cosperpharm for the development and quality control of Orforglipron—a first‑in‑class, orally administered small‑molecule GLP‑1 receptor agonist developed by Eli Lilly for the treatment of type 2 diabetes and obesity. This Orforglipron Impurity 20 serves a dual function: as an indispensable synthetic building block in the multi‑step assembly of the Orforglipron API, and as a critical reference standard for impurity profiling, forced degradation studies, and analytical method validation. At Cosperpharm, each batch of Orforglipron Impurity 20 is manufactured under stringent quality guidelines, ensuring batch‑to‑batch reproducibility and full regulatory compliance. With its well‑defined stereochemistry and high purity, Orforglipron Impurity 20 enables researchers to accurately monitor reaction progress during API synthesis and to quantify impurity levels in final drug product testing, thereby supporting successful ANDA, DMF, and IND submissions.

Product Parameters

Synthetic Route

Orforglipron Impurity 20 is a key intermediate in the convergent synthetic strategy for Orforglipron (LY3502970), which involves the coupling of two major fragments: an indole‑2‑carboxylic acid derivative and an imidazol‑2‑one‑substituted pyrazolopyridine derivative. This compound specifically belongs to the indole‑2‑carboxamide series of intermediates, wherein the indole core undergoes functionalization at the 5‑position with the chiral tetrahydropyran moiety and at the 1‑position with the (1S,2S)-cyano‑methylcyclopropyl group. The introduction of the chiral cyclopropyl group is typically achieved via stereocontrolled cyclopropanation or alkylation strategies employing chiral auxiliaries. The final amide bond between the indole‑2‑carboxylic acid and N‑methyl‑N‑phenylamine completes the structure. Detailed proprietary process information is protected by patents (WO2024137426A1). For non‑confidential synthetic references or custom synthesis inquiries, please contact Cosperpharm.

Applications

1.Orforglipron API synthesis – key late‑stage intermediate in the multi‑step manufacturing of this oral GLP‑1 receptor agonist for diabetes and obesity treatment.

2.Analytical method development – reference standard for HPLC and LC‑MS method validation and impurity profiling.

3.Forced degradation studies – to identify, characterize, and quantify degradation products of Orforglipron formulations.

4.Quality control (QC) – routine testing and release of Orforglipron API and finished drug product batches.

5.Regulatory submissions – ANDA, IND, and DMF filings requiring impurity reference standards.

6.Process development – monitoring synthetic reaction progress, yield optimization, and impurity tracking during scale‑up.

7.GLP‑1 drug research – as an intermediate in the development of novel oral small‑molecule GLP‑1 receptor agonists for metabolic disorders.

Quality Assurance

Cosperpharm manufactures Orforglipron Impurity 20 under a robust quality management system aligned with ICH Q7 guidelines. Each batch undergoes rigorous testing including HPLC purity (≥98%), identity verification by mass spectrometry, residual solvent analysis, and comprehensive impurity profiling. Full characterization data (HPLC chromatograms, MS spectra, and optionally NMR spectra) are provided with each shipment. We maintain retained samples for every batch and provide full traceability from raw material sourcing through final shipment. Accelerated and long‑term stability data are available upon request. Multiple commercial suppliers have validated this compound as a qualified reference standard for Orforglipron quality control applications.

Contact Us

Ready to purchase Orforglipron Impurity 20 or request a sample? Contact Cosperpharm today for a competitive quote, product information, or technical consultation.