Pioglitazone

Pioglitazone

Параметр Технические характеристики
Название продукта Pioglitazone
Номер CAS 111025-46-8
Молекулярная формула C19H20N2O3S
Молекулярная масса 356.44 g/mol
Внешний вид Кристаллический порошок от белого до небелого цвета
Анализ (ВЭЖХ) ≥99,01 TP3T
Растворимость Soluble in DMSO, methanol; practically insoluble in water
Упаковка 25 kg fiber drum with double polyethylene bags

Pioglitazone Structure

Синонимы: Pioglitazone, U-72107A, AD-4833, (±)-5-[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione

Pioglitazone is a thiazolidinedione-class antidiabetic agent that has maintained a steady position in the type 2 diabetes market, particularly in combination regimens where insulin sensitization is needed. While newer drug classes have gained attention, pioglitazone remains relevant for its well-characterized efficacy, oral bioavailability, and cost-effectiveness in generic formulations.

Chemically, pioglitazone is a synthetic compound with the molecular formula C19H20N2O3S and a molecular weight of 356.44 g/mol. It acts as a peroxisome proliferator-activated receptor gamma (PPAR-γ) agonist, improving insulin sensitivity in peripheral tissues. The compound is typically produced as the hydrochloride salt for pharmaceutical use, though the free base is also available for research and formulation development.

Our pioglitazone is manufactured under strict cGMP conditions and standardized to ≥99.0% purity by HPLC. It is supplied as a white to off-white crystalline powder, soluble in organic solvents like DMSO and methanol but practically insoluble in water. This profile makes it suitable for oral solid dosage forms and a range of preclinical research applications.

Product Overview & Composition

Pioglitazone is a member of the thiazolidinedione class, structurally characterized by a 2,4-thiazolidinedione ring linked to a pyridine-ethyl-benzyl moiety. The active pharmaceutical ingredient (API) is often used as the hydrochloride salt to enhance stability and solubility. The free base form is also available for specific research and formulation needs.

The compound is synthesized through a multi-step process that yields high-purity material suitable for pharmaceutical manufacturing. Our production follows ICH guidelines, ensuring consistent quality and regulatory compliance.

Applications & Product Lines

  • Type 2 diabetes therapeutics: Used as monotherapy or in combination with metformin, sulfonylureas, or insulin to improve glycemic control.
  • Generic drug manufacturing: A key API for generic pioglitazone tablets and fixed-dose combinations.
  • Research and development: Employed in studies investigating insulin resistance, PPAR-γ biology, and metabolic disorders.
  • Contract manufacturing: Supplied to CDMOs for formulation development and clinical trial materials.

Quality Control Standards

Test Item Технические характеристики
Идентификация IR, HPLC retention time conforms to standard
Потери при сушке ≤0,51 TP3T
Тяжелые металлы ≤20 ppm
Microbial Limits Total aerobic count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; absence of E. coli and Salmonella
Органические примеси Any individual impurity ≤0.1%; total impurities ≤0.5%
Остаток после прокаливания ≤0,11 TP3T

Bulk Packaging & Supply

  • Packaging: 25 kg fiber drums with double polyethylene liners, or as per customer requirements.
  • MOQ: 1 kg for trial orders; 25 kg for commercial quantities.
  • Срок выполнения заказа: 3-5 business days for stock items.
  • Documentation: COA, MSDS, TDS, and regulatory support available upon request.

Frequently Asked Questions

What is the minimum order quantity (MOQ) for pioglitazone?

We offer flexible MOQs: 1 kg for trial orders and 25 kg for commercial quantities. Larger volumes can be accommodated with scheduled deliveries.

How long does delivery take?

For stock items, delivery is typically 3-5 business days after order confirmation. We maintain adequate inventory to ensure prompt shipment.

Can you provide a COA and samples?

Yes, a certificate of analysis (COA) is available for each batch. Samples can be provided upon request, usually shipped within 1-2 days.

What are the packaging options?

Standard packaging is 25 kg fiber drums with double polyethylene liners. Custom packaging is available to meet specific requirements.

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.

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