Empagliflozin

Synonyms: (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol, BI 10773, Jardiance, Glyxambi, Synjardy, Empagliflozinum

Empagliflozin has quickly become a flagship molecule in the SGLT2 inhibitor class, and demand from formulators reflects that. Since its approval, it has moved well beyond type 2 diabetes into heart failure and chronic kidney disease indications, which has widened the customer base considerably. For generic and specialty manufacturers, the API is now a core line item rather than a niche addition.

Chemically, empagliflozin is a C-glucoside bearing a chlorinated biphenyl-like scaffold. It is synthesized through a multistep route that typically starts from a protected glucose derivative and a substituted benzyl halide, followed by stereoselective glycosylation and deprotection. The resulting molecule is a potent, orally active inhibitor of sodium-glucose cotransporter 2 (SGLT2), responsible for the majority of renal glucose reabsorption.

We supply empagliflozin with an assay of ≥99.5% by HPLC, produced under cGMP conditions. Each batch is tested for residual solvents, heavy metals, and related substances to meet pharmacopeial expectations. The material is micronized to a consistent particle size, which helps with blend uniformity in tablet formulations. It is available in development quantities as well as commercial-scale lots.

Product Overview & Composition

Empagliflozin is a single enantiomer, and enantiomeric purity is critical for activity. Our material is manufactured with a stereoselective route that minimizes the formation of the undesired enantiomer. The API is non-hygroscopic under normal storage conditions and shows good stability in the solid state.

It is practically insoluble in water but freely soluble in polar aprotic solvents like DMSO and DMF. This solubility profile is well suited to standard wet granulation and roller compaction processes. The substance does not require special handling beyond routine API precautions.

Applications & Product Lines

• Type 2 diabetes: Used as monotherapy or in fixed-dose combinations with metformin, linagliptin, or insulin.
• Heart failure: Indicated to reduce the risk of cardiovascular death and hospitalization in adults with heart failure.
• Chronic kidney disease: Slows the progression of kidney disease in patients with or without diabetes.
• Fixed-dose combinations: Common with metformin (Synjardy) and linagliptin (Glyxambi).
• Research: Employed in studies on glucose metabolism, renal physiology, and cardiorenal protection.

Quality Control Standards

Bulk Packaging & Supply

• Packaging: 25 kg net fiber drum with double polyethylene liner; also available in 1 kg and 5 kg aluminum foil bags for development.
• MOQ: 1 kg for pilot batches; 25 kg for commercial orders.
• Lead time: 3-5 business days (stock items)
• Documentation: COA, MSDS, TDS, and cGMP statement provided with each shipment. DMF available upon request.

Frequently Asked Questions

What is the minimum order quantity?

Our MOQ is 1 kg for development and pilot-scale needs. For commercial supply, we recommend 25 kg drums, but we can accommodate intermediate quantities.

What is the typical lead time?

Stock items ship within 3-5 business days. Custom synthesis or large-volume orders typically require 3-5 business days, depending on scheduling and batch size.

Do you provide a COA and samples?

Yes, a COA is issued for every batch. We can provide samples (typically 10–50 g) for evaluation, along with MSDS and TDS. Sample requests are usually processed within 48 hours.

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

Learn more about our quality control and certifications, or send us your specification for a quotation.