Description

Glipizide Impurity H-D11 is a deuterated impurity standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antidiabetic drug Glipizide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The deuterated form provides a stable internal standard for precise quantitative analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Glipizide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and GC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and degradation of impurities in Glipizide under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Metabolic and Pharmacokinetic Research: The deuterated label aids in tracing and studying the metabolic pathways and stability of Glipizide and its related compounds.

Basic Information

Item	Detail
Product Name	Glipizide Impurity H-D11
CAS No.	1794979-66-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea-d11; Glipizide Related Compound H-D11; Deuterated Glipizide Impurity H; Glipizide-d11 Impurity H; N-[[4-[[[[(Hexadeutero)cyclohexyl]amino]carbonyl]amino]sulfonyl]phenethyl]-5-methyl-2-pyrazinecarboxamide-d5
EINECS	Contact for details

Quality Control

Every batch of Glipizide Impurity H-D11 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, isotopic enrichment (D%), and confirmation of structure via spectroscopic methods. A detailed Certificate of Analysis (COA) is supplied with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D%)	≥ 98.0 atom % D
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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