Linagliptin

Синонимы: 2-[[(3R)-3-Amino-1-piperidinyl]-3,4-dihydro-3-oxo-1(2H)-isoquinolinyl]methyl]-4-methyl-1H-isoindole-1,3(2H)-dione, Tradjenta, Glyxambi, Jentadueto, BI 1356

Linagliptin has become a go-to DPP-4 inhibitor for formulators targeting type 2 diabetes, particularly in combination products where metformin or empagliflozin is the partner. Demand is steady from generic and specialty pharma companies alike, driven by its once-daily dosing, no renal dose adjustment, and minimal drug-drug interaction profile.

Chemically, linagliptin is a xanthine-based small molecule with a (R)-3-aminopiperidine side chain. It works by binding reversibly to the DPP-4 enzyme, slowing the breakdown of incretin hormones GLP-1 and GIP. This mechanism is well understood across the class, but linagliptin’s distinguishing feature is its predominantly biliary excretion—less than 5% renal—which sets it apart for patients with impaired kidney function.

Commercial material is held to tight purity specs, typically ≥99.0% by HPLC. Our production follows cGMP, with full traceability from API batch to final drum. Whether you are scaling a generic launch or running clinical batches, the documentation and consistency are there to support your filing.

Product Overview & Composition

Linagliptin is a synthetic small molecule, not a biological or botanical extract. It is manufactured through a multi-step chemical synthesis, starting from isoindoline-1,3-dione derivatives and piperidine building blocks. The final API is isolated as a crystalline free base, which offers good stability under normal storage conditions.

Each batch is characterized for identity, assay, and impurity profile. Residual solvents and elemental impurities are controlled according to ICH Q3C and Q3D guidelines. The material is micronized to a consistent particle size to support blend uniformity in solid dosage forms.

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 or empagliflozin for simplified regimens.
• Renal impairment populations: No dose adjustment needed, making it suitable for a broader patient base.
• Generic formulations: Immediate-release tablets, often 5 mg strength, for global markets.
• Research use: Reference standard and impurity profiling in analytical labs.

Quality Control Standards

Bulk Packaging & Supply

• Packaging: 25 kg fiber drum with double polyethylene liners, or as requested.
• MOQ: 1 kg for pilot; 25 kg for commercial orders.
• Срок выполнения заказа: 3–5 рабочих дней (товары, имеющиеся в наличии)
• Documentation: COA, MSDS, TDS, and cGMP statement provided with each shipment.

Frequently Asked Questions

What is the minimum order quantity?

We can supply from 1 kg for development work, but commercial pricing applies from 25 kg.

How long does delivery take?

Stock material ships within 3-5 business days. Custom packaging may take 3-5 business days.

Do you provide a COA and samples?

Yes, a COA is issued for every batch, and samples up to 100 g are available for evaluation.

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.