Dapagliflozin

Synonyme: (2S,3R,4R,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol, BMS-512148, Farxiga, Forxiga, Edistride, Dapagliflozinum

Dapagliflozin has become a cornerstone in the management of type 2 diabetes and related cardiorenal conditions. As an orally active sodium-glucose cotransporter 2 (SGLT2) inhibitor, it offers a glucose-lowering effect independent of insulin secretion, which has driven its inclusion in fixed-dose combinations and its expansion into heart failure and chronic kidney disease indications. For procurement teams and formulation scientists, the molecule’s reliable manufacturing scale and well-characterized impurity profile make it a practical choice for both generic development and innovative combination products.

Chemically, dapagliflozin is a C-aryl glucoside. The active pharmaceutical ingredient (API) is manufactured via a multi-step synthesis that introduces the chloro and ethoxybenzyl substituents on the aglycone core, followed by stereoselective glycosylation. The resulting crystalline form is thermodynamically stable and exhibits good oral bioavailability. Quality control focuses on controlling chiral purity, residual solvents, and genotoxic impurities to meet ICH Q3A/Q3C requirements.

We supply dapagliflozin with a typical assay of ≥99.0% (HPLC) and a defined particle size distribution suitable for direct compression or wet granulation. Each batch is accompanied by a comprehensive COA, MSDS, and TDS, and is manufactured under cGMP conditions. The material is available from stock in 25 kg fiber drums, with smaller pack sizes for pilot and stability studies.

Produktübersicht und Zusammensetzung

Dapagliflozin is a highly selective SGLT2 inhibitor. Its molecular structure features a glucose moiety linked to a chlorinated benzyl-ethoxy benzene ring, which confers high affinity for the SGLT2 transporter in the proximal renal tubule. The API is typically supplied as the crystalline free base or as the propanediol solvate, depending on the intended formulation. The propanediol form is often used in tablet manufacturing to improve flow and compressibility.

Applications & Product Lines

• Type 2 diabetes monotherapy: Used as an adjunct to diet and exercise to improve glycemic control.
• Fixed-dose combinations: Co-formulated with metformin, saxagliptin, or insulin for enhanced efficacy.
• Heart failure: Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.
• Chronic kidney disease: Slows the progression of renal impairment in patients with or without diabetes.
• Research and development: Reference standard for analytical method development and bioequivalence studies.

Quality Control Standards

Bulk Packaging & Supply

• Verpackung: 25 kg fiber drum with dual polyethylene liners; 1 kg and 5 kg pack sizes available for R&D.
• Mindestbestellmenge: 1 kg for pilot scale; 25 kg for commercial orders.
• Lieferzeit: 3-5 business days for stock items.
• Dokumentation: COA, MSDS, TDS, and cGMP declaration provided with each shipment.

Häufig gestellte Fragen

What is the minimum order quantity for dapagliflozin?

We offer flexible MOQs: 1 kg for pilot and stability studies, and 25 kg for commercial production. Larger quantities can be accommodated upon request.

How long does delivery take?

For stock items, delivery is 3-5 business days from order confirmation.

Can you provide a COA and sample for evaluation?

Yes, a COA is included with every batch. Samples are available upon request and are typically dispatched within 1-2 days.

Contact & Ordering Information

• Company: LyvBio Co., Ltd.
• Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
• Email: info@lyvbio.com
• Phone: +86-29-65816888

send us your specification for a quotation.