Description

Valdecoxib Impurity-E 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) Valdecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The availability of this well-characterized impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Valdecoxib Impurity-E in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Valdecoxib API to monitor and control impurity levels according to ICH guidelines.
• Stability Studies: Acts as a marker to track the formation of degradation products in Valdecoxib formulations under various stress conditions.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and behavior.

Basic Information

Product Name	Valdecoxib Impurity-E
CAS No.	1373038-63-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valdecoxib Related Compound E; Valdecoxib EP Impurity E; Valdecoxib USP Impurity E; 4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide Impurity E; BMS-347070 Impurity-E; COX-2 Inhibitor Impurity; Degradation Product of Valdecoxib
EINECS	Contact for details

Quality Control

Our Valdecoxib Impurity-E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 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
Water Content (KF)	≤ 1.0%

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