Description

Gliclazide Impurity 2 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 widely prescribed medication for type 2 diabetes. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of this specific impurity in Gliclazide API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to ensure accurate impurity detection.
• Quality Assurance/Quality Control (QA/QC) Testing: Employed in routine batch release testing of Gliclazide to verify compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies and Forced Degradation Testing: Acts as a marker to study the degradation pathways and stability profile of Gliclazide under various stress conditions.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Utilized in synthetic chemistry and pharmaceutical R&D for studying impurity formation mechanisms and developing purification processes.

Basic Information

Product Name	Gliclazide Impurity 2
CAS No.	1550510-52-5
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 2; Gliclazide EP Impurity B; Gliclazide USP Impurity; Gliclazide Process Impurity; N-[(3aR,6aS)-Octahydrocyclopenta[c]pyrrol-3-yl]-N'-(4-methylphenyl)sulfonylurea; Gliclazide Impurity B (EP)
EINECS	Contact for details

Quality Control

Every batch of Gliclazide Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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