Description
High Purity Ertugliflozin L-Pyroglutamic Acid API | SGLT2 Inhibitor | CAS 1210344-57-2
Product Overview
Ertugliflozin L-Pyroglutamic Acid is a high-purity, pharmaceutical-grade active pharmaceutical ingredient (API) and key intermediate belonging to the SGLT2 inhibitor class. It is primarily used in the treatment of type 2 diabetes mellitus (T2DM) by inhibiting sodium-glucose cotransporter-2 in the kidneys, thereby promoting urinary glucose excretion and improving glycemic control.
This product is supplied as a stable salt form (L-pyroglutamic acid) that enhances the physicochemical properties of the parent compound. It is manufactured under strict GMP conditions and meets rigorous purity specifications, making it ideal for generic drug development, formulation, and commercial production.
Key Specifications
| Parameter | Details |
|---|---|
| Product Name | Ertugliflozin L-Pyroglutamic Acid |
| CAS Number | 1210344-57-2 |
| Molecular Formula | C₂₂H₂₅ClO₇ · C₅H₇NO₃ |
| Molecular Weight | 566.98 g/mol |
| Grade | Pharmaceutical Grade |
| Assay (HPLC) | ≥ 99.0% |
| Appearance | White to off-white crystalline powder |
| Shelf Life | 3 years when stored under proper conditions |
| Storage | Tight container, protected from light and moisture, stored at controlled room temperature |
Therapeutic Applications
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Type 2 Diabetes Mellitus – As a potent and selective SGLT2 inhibitor, it reduces renal glucose reabsorption, leading to increased urinary glucose excretion and improved glycemic control.
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Combination Therapy – Often used in fixed-dose combinations with metformin or other antidiabetic agents.
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Cardiovascular and Renal Benefits – SGLT2 inhibitors are associated with reduced risk of major adverse cardiovascular events and slowing of chronic kidney disease progression in diabetic patients.
Ertugliflozin acts independently of insulin secretion and beta-cell function, providing a complementary mechanism to other oral antidiabetic agents.
Product Advantages
✅ High Purity – HPLC assay ≥ 99.0%, with strict control of related substances and residual solvents.
✅ GMP Certified Facility – Manufactured in facilities audited to international GMP standards (WHO, EU, or equivalent).
✅ Stable Supply Chain – Large-scale production capacity ensures consistent availability for R&D, clinical, and commercial quantities.
✅ Complete Documentation – Available with DMF (Drug Master File), COA, stability data, and regulatory support for global filing.
✅ Competitive Pricing – Direct from manufacturer, offering cost advantages for generic and branded formulation projects.
Quality Control & Compliance
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Purity by HPLC – Every batch is tested for assay, related substances, and impurity profile in accordance with in-house validated methods and pharmacopoeial guidelines.
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Residual Solvents – Controlled according to ICH Q3C guidelines.
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Stability Studies – Long-term and accelerated stability data available, confirming integrity under recommended storage conditions.
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Microbial Limits – Strictly controlled to meet pharmaceutical safety standards.
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Regulatory Support – DMF filing assistance provided for major markets (US, Europe, Japan, etc.).
Packaging & Shipping
| Packaging Type | Specification |
|---|---|
| Standard | 1 kg, 5 kg, 10 kg, 25 kg double-layer polyethylene bags in fiber drums or aluminum foil bags |
| Customization | Available upon request (small-scale R&D packaging, special labeling) |
| Shipping | Ambient temperature with protection from moisture and light; sealed containers to ensure product integrity |
All shipments are accompanied by batch-specific COA, MSDS, and shipping documents.
Why Choose Us?
As a professional manufacturer and supplier of Ertugliflozin L-Pyroglutamic Acid, we combine technical expertise with reliable service. Our team offers:
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Technical Support – Assistance with formulation development, method validation, and impurity identification.
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Regulatory Compliance – DMF preparation and maintenance, support for customer filings.
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Flexible Quantities – From gram-scale for R&D to multi-ton commercial batches.
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Global Logistics – Experienced in export to North America, Europe, Asia, and other regions, with proper documentation.
Contact Us
For inquiries, samples, or to request a quote for Ertugliflozin L-Pyroglutamic Acid (CAS 1210344-57-2) , please contact us directly. We look forward to supporting your SGLT2 inhibitor projects with quality, consistency, and reliability.
Tags: *Ertugliflozin L-Pyroglutamic Acid, Ertugliflozin API, CAS 1210344-57-2, SGLT2 inhibitor, pharmaceutical grade, high purity API, anti-diabetic API, type 2 diabetes treatment, GMP manufacturer, active pharmaceutical ingredient, SGLT2 inhibitor intermediate*
