Description

Hydroxyglimepiride is a key pharmaceutical intermediate and reference standard, identified by CAS NO 127554-89-6. This compound is of significant importance in the research, development, and quality control of advanced therapeutic agents, particularly in the field of metabolic disorders. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug synthesis and validation processes.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of novel active pharmaceutical ingredients (APIs) and their derivatives.
• Analytical Reference Standard: Used for method development, validation, and quality control testing (e.g., HPLC, LC-MS) in pharmaceutical analysis.
• Metabolic Research: Serves as a valuable compound in preclinical and clinical research studies focused on diabetes and related metabolic pathways.
• Impurity Profiling: Employed as a certified reference material to identify and quantify related substances and degradation products in drug substances and products.
• Chemical Synthesis: Utilized in organic synthesis for the preparation of more complex molecules with potential therapeutic activity.

Basic Information

Product Name	Hydroxyglimepiride
CAS No.	127554-89-6
Molecular Formula	C24H34N4O5S
Molecular Weight	490.62 g/mol
Synonyms	1-[[4-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-hydroxycyclohexyl)urea; Glimepiride Hydroxy Metabolite; Glimepiride Impurity; M-1 Metabolite; Hydroxy Glimepiride; trans-4-Hydroxycyclohexyl Glimepiride
EINECS	Contact for details

Quality Control

Our Hydroxyglimepiride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and mass spectrometry, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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