Teneligliptin Hydrobromide API 906093-29-6

The pharmaceutical industry constantly seeks effective treatments for chronic conditions like Type 2 diabetes. One notable active pharmaceutical ingredient (API) is the teneligliptin hydrobromide api 906093-29-6. This compound has gained attention for its specific mechanism of action and clinical benefits. Therefore, this guide provides a comprehensive overview of this important API.

What is Teneligliptin Hydrobromide API?

Teneligliptin Hydrobromide is a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. Pharmaceutical companies use it to manage Type 2 diabetes mellitus. Its chemical structure, specifically the “anchor-locked” molecular design, allows for strong and sustained inhibition of the DPP-4 enzyme. The hydrobromide salt form is preferred for the final API. This is because it enhances the compound’s stability and handling characteristics during formulation.

As a therapeutic agent, teneligliptin regulates blood glucose levels effectively. Following oral administration, it works by increasing the levels of active incretin hormones, such as GLP-1 and GIP. These hormones stimulate insulin secretion and suppress glucagon release in a glucose-dependent manner. This mechanism provides glycemic control with a low risk of hypoglycemia compared to some other antidiabetic agents.

Key Specifications of Teneligliptin Hydrobromide CAS 906093-29-6

Technical specifications are necessary for ensuring the quality and consistency of an API. For teneligliptin hydrobromide, these parameters guide its use in pharmaceutical manufacturing. The table below outlines its key technical data.

Purity is a non-negotiable standard for any pharmaceutical grade API. The teneligliptin hbr api must comply with strict standards outlined in pharmacopeias like the USP, BP, and EP. Manufacturers typically supply the material with an assay of 99% or higher. This ensures minimal impurities and maximum efficacy and safety in the final drug product.

In the industry, this compound is known by several synonyms. These names help in search and procurement processes. Common identifiers include Teneligliptin HBr, Teneligliptin Hydrobromide, and its CAS number, teneligliptin hydrobromide cas 906093-29-6.

How is Teneligliptin Hydrobromide API Manufactured?

The production of teneligliptin hydrobromide api 906093-29-6 involves a multi-step chemical synthesis process. This process requires precise control over reaction conditions to achieve high purity and yield. The synthesis typically starts from readily available raw materials and proceeds through several key intermediates.

A high-level overview of the synthesis process involves several distinct chemical reactions. For instance, chemists often construct the core thiazolidine ring and subsequently attach the piperidine side chain. Each step is carefully designed to build the complex molecular architecture of teneligliptin.

Critical intermediates are necessary for the successful synthesis of the final API. These include specific piperidine derivatives and substituted thiazolidine compounds. The quality of these teneligliptin hydrobromide intermediates directly impacts the purity of the final product. For this reason, suppliers must adhere to stringent quality specifications for these raw materials.

Quality control is paramount throughout the manufacturing process. Reputable manufacturers follow International Council for Harmonisation (ICH) guidelines. They continuously monitor the process to control impurity profiles. Techniques like High-Performance Liquid Chromatography (HPLC) are used to detect and quantify any potential impurities.

Applications and Pharmaceutical Formulations

The primary application of teneligliptin hydrobromide is in the formulation of antidiabetic medications. It is available in various dosage forms to suit different patient needs. The most common form is standalone tablets, typically administered once daily.

Additionally, teneligliptin is often used in fixed-dose combinations (FDCs). These combinations pair it with other antidiabetic drugs like Metformin or Dapagliflozin. FDCs can improve patient compliance by reducing the number of pills a person needs to take each day. This approach also targets different pathways of glucose metabolism for enhanced glycemic control.

Teneligliptin offers several clinical advantages. It has a long half-life. Furthermore, it is considered safe for use in patients with renal impairment. The drug is excreted through both renal and hepatic pathways.

Proper storage is necessary to maintain the integrity of the API. Teneligliptin hydrobromide raw material should be stored in well-closed containers. It must be protected from light and moisture. Recommended storage conditions are typically at a controlled room temperature to prevent degradation and ensure long-term stability.

Sourcing Teneligliptin Hydrobromide Bulk Supply

Finding reliable teneligliptin hydrobromide suppliers is a critical step for pharmaceutical formulators. When evaluating potential manufacturers, companies should look for several key indicators of quality. Good Manufacturing Practice (GMP) certification is necessary, as it demonstrates adherence to global quality standards. The availability of a Drug Master File (DMF) is another important factor.

Market dynamics can influence the price and availability of teneligliptin hydrobromide bulk supply. Factors such as the cost of raw materials. As of 2026, the demand for effective DPP-4 inhibitors remains strong, making the market for teneligliptin competitive.

Regulatory documentation plays an important role in the procurement process. A USDMF (United States Drug Master File) or KDMF (Korean Drug Master File) provides confidential, detailed information about the API’s manufacturing process to regulatory authorities. The availability of these documents streamlines the drug approval process for pharmaceutical companies looking to use the API in their products.

Frequently Asked Questions (FAQ)

What is the CAS number for Teneligliptin Hydrobromide?
The CAS number for Teneligliptin Hydrobromide is 906093-29-6. This number is a unique identifier for this specific chemical substance.

Is Teneligliptin HBr safe for renal patients?
Yes, teneligliptin is generally considered safe for patients with mild to severe renal impairment. It has a dual excretion profile. This reduces the risk of drug accumulation in patients with compromised kidney function.

How does Teneligliptin differ from Sitagliptin?
Both are DPP-4 inhibitors, but they have different chemical structures and binding properties. Teneligliptin is known for its strong “anchor-locked” binding to the DPP-4 enzyme. This unique binding affinity is a key distinction from other gliptins like Sitagliptin.