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Orforglipron Impurity 18
  • Orforglipron Impurity 18Orforglipron Impurity 18

Orforglipron Impurity 18

Model: 2212022-56-3
Orforglipron Impurity 18 (CAS 2212022-56-3) is a key intermediate and related impurity of the novel oral non‑peptide GLP‑1 receptor agonist Orforglipron, developed for the treatment of type 2 diabetes and obesity.From a structural perspective, this molecule features a complex polyheterocyclic scaffold. The core comprises an imidazol‑2‑one ring fused to a tetrahydro‑pyrazolo[4,3‑c]pyridine system, which is further substituted with a 4‑fluoro‑1‑methyl‑1H‑indazole moiety and a 4‑fluoro‑3,5‑dimethylphenyl group. The presence of two fluorine atoms enhances metabolic stability and lipophilicity, while the chiral center at the tetrahydropyridine ring (S‑configuration) is crucial for the biological activity of the final drug. The molecular framework allows precise interaction with the GLP‑1 receptor, and this intermediate serves as an essential building block in the multi‑step synthesis of Orforglipron.

Orforglipron Impurity 18 (CAS 2212022‑56‑3) is a high‑purity reference standard and synthetic intermediate supplied by Cosperpharm. As an Orforglipron Impurity 18, it is primarily used for process development, quality control, and regulatory studies during Orforglipron API manufacturing. Unlike the final drug, Orforglipron Impurity 18 retains the key stereochemistry and heterocyclic core, enabling researchers to monitor reaction progress and final product purity. Cosperpharm produces Orforglipron Impurity 18 under strict quality guidelines, ensuring batch‑to‑batch consistency.

This compound is not intended for direct human therapeutic use but is indispensable for the safe and compliant production of Orforglipron, a promising oral therapy for metabolic disorders. With its well‑defined structure and high purity, Orforglipron Impurity 18 supports accurate analytical method development (HPLC, MS, NMR) and stability studies.


Product Parameters

Parameter

Specification

CAS Number

2212022-56-3

Molecular Formula

C₂₆H₂₅F₂N₇O

Molecular Weight

489.52 g/mol

Purity (HPLC)

≥98.0%

Any single impurity

≤0.5%

Total impurities

≤1.0%

Appearance

White to off-white solid

Density (Predicted)

1.45 ± 0.1 g/cm³

Boiling Point (Predicted)

650.0 ± 65.0 °C

pKa (Predicted)

8.39 ± 0.40

Solubility

Soluble in DMSO, DMF, and methanol; slightly soluble in water

Storage

2–8°C, dry, protected from light, airtight

Why Cosperpharm?

Cosperpharm is a trusted supplier of high‑purity pharmaceutical impurities and intermediates. With a GMP‑compliant campus and advanced analytical capabilities (HPLC, GC‑MS, NMR), we ensure that every batch of Orforglipron Impurity 18 meets strict quality specifications. We provide full documentation (COA, stability data, MSDS) to support your regulatory filings. Our efficient logistics and responsive technical support make Cosperpharm your reliable partner in drug development.


Product Advantages

1.High purity (≥98% by HPLC) with tightly controlled impurities.

2.Full characterization – provided with HPLC, MS, and NMR data upon request.

3.Flexible packaging – from milligram R&D samples to gram‑scale supplies.

4.Competitive lead time – 1–2 weeks for stock, 4–6 weeks for custom synthesis.

5.Strict quality system – each batch is retested before shipment.

6.Regulatory support – detailed impurity profiling for ANDA/IND filings.


Synthetic Route

The synthesis of Orforglipron Impurity 18 involves a multi‑step convergent route starting from substituted indazole and pyrazolo‑pyridine intermediates, followed by chiral resolution or asymmetric synthesis to establish the (S)‑configuration. Detailed proprietary information is protected by patents. For non‑confidential synthetic references, please contact Cosperpharm – we can provide general process information under a confidentiality agreement.


Frequently Asked Questions (FAQ)

Q1: What is Orforglipron Impurity 18 used for?

A: It is used as a reference standard for HPLC method development, impurity tracking, and stability studies during Orforglipron API manufacturing.


Q2: Is this product the same as Orforglipron API?

A: No. It is an intermediate/impurity, not the active pharmaceutical ingredient. It is intended for laboratory use only.


Q3: Can you supply larger quantities ( >1 g )?

A: Yes. Cosperpharm offers custom synthesis and bulk supply. Please contact us for a quote.


Contact Us

Ready to order Orforglipron Impurity 18 or request a sample?Reach out to Cosperpharm today for a competitive quote and technical support.


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