Description

Valdecoxib Impurity F-13C2,15N is a stable isotope-labeled impurity standard used for the analytical profiling and quality control of the pharmaceutical compound Valdecoxib. This high-purity reference material is critical for ensuring the safety and efficacy of drug products by enabling accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Valdecoxib Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Valdecoxib API.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of specific impurities over time.
• Metabolism and Pharmacokinetic Research: The 13C and 15N labels make it valuable as an internal standard in mass spectrometry for advanced bioanalytical studies.

Basic Information

Product Name	Valdecoxib Impurity F-13C2,15N
CAS No.	1391051-92-5
Molecular Formula	C1613C2H14N15NO3S
Molecular Weight	Contact for details
Synonyms	4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide-13C2,15N; Valdecoxib-13C2,15N Impurity F; Isotopically Labeled Valdecoxib Impurity F; BMS-347070 Impurity F (Labeled); [13C2,15N]-Valdecoxib Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib Impurity F-13C2,15N is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced spectroscopic and chromatographic techniques, to ensure identity, purity, and isotopic enrichment meet exacting standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, isotopic purity, and related substances is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 99 atom % 15N
Chemical Purity	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%

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