Description

Gliclazide Impurity D is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Gliclazide, a medication used to treat type 2 diabetes. It is an essential material for pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Gliclazide Impurity D in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing of Gliclazide API to meet pharmacopeial (USP, EP) specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Gliclazide formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization reports.
• Research & Development (R&D): Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the API.

Basic Information

Product Name	Gliclazide Impurity D
CAS No.	1136426-19-1
Molecular Formula	C15H21N3O3S
Molecular Weight	323.41 g/mol
Synonyms	1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-(4-methylphenylsulfonyl)urea; Gliclazide Related Compound D; Gliclazide EP Impurity D; Gliclazide USP Impurity D; Gliclazide Descyclopentyl Impurity; 3-(4-Methylphenylsulfonyl)-1-(octahydrocyclopenta[c]pyrrol-5-yl)urea
EINECS	Contact for details

Quality Control

Every batch of Gliclazide Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.