Description

Ertugliflozin L-Pyroglutamic Acid is a high-purity salt form of the active pharmaceutical ingredient ertugliflozin, a selective SGLT2 inhibitor. This specific co-crystal or salt formation is critical for enhancing the stability, bioavailability, and manufacturability of the final drug product. It is an essential advanced pharmaceutical intermediate for the production of anti-diabetic medications. Pharmaceutical manufacturers and advanced R&D facilities require this compound for developing and scaling up treatments for type 2 diabetes.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Primary use in the synthesis of the finished dosage form of the SGLT2 inhibitor drug, Ertugliflozin.
• Pharmaceutical Formulation Development: Used in pre-formulation and formulation studies to optimize drug product stability and performance.
• Process Chemistry & Scale-Up: Serves as a key starting material (KSM) or intermediate in the commercial-scale manufacturing process.
• Reference Standard: Can be utilized as a high-purity standard for analytical method development and quality control testing.
• Research & Development: Employed in biomedical research to study the pharmacology and metabolic effects of SGLT2 inhibition.
• Regulatory Filings: Supplied for use in generating data for regulatory submissions (e.g., DMF, CMC sections).

Basic Information

Product Name	Ertugliflozin L-Pyroglutamic Acid
CAS No.	1210344-83-4
Molecular Formula	C27H30N2O8
Molecular Weight	510.54 g/mol
Synonyms	(1S,2S,3S,4R,5S)-5-(4-Chloro-3-((4-((3S)-tetrahydrofuran-3-yloxy)phenyl)methyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol; (2S)-5-Oxo-L-proline; Ertugliflozin L-Pyroglutamate; Ertugliflozin Pyroglutamic Acid Salt; PF-04971729 L-Pyroglutamate; L-Pyroglutamic acid salt of Ertugliflozin
EINECS	Contact for details

Quality Control

Our Ertugliflozin L-Pyroglutamic Acid is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical intermediates, including identity, purity, and impurity profiles. We support regulatory compliance with traceable documentation. Certificates of Analysis (COA) are provided with each shipment and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.