Description

Valdecoxib Impurity D-13C2,15N is a stable isotope-labeled impurity standard used for analytical reference and method development. This compound is critical for ensuring the accuracy and reliability of pharmaceutical quality control processes, specifically for the drug Valdecoxib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for precise quantification and identification of impurities during drug substance and product testing. The use of this labeled standard is essential for meeting stringent pharmacopeial requirements and ensuring patient safety.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Valdecoxib Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating sensitive and specific analytical methods, such as HPLC-MS/MS, to monitor impurity profiles.
• Metabolic Studies: Employed as an internal standard in mass spectrometry-based studies to track the degradation pathways and stability of Valdecoxib.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch release testing in GMP environments to ensure impurity levels are within specified limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Testing: Used in forced degradation studies and long-term stability programs to assess the formation of Impurity D over time under various conditions.

Basic Information

Product Name	Valdecoxib Impurity D-13C2,15N
CAS No.	1391053-52-3
Molecular Formula	C16H12D2N2O3S * (13C2, 15N)
Molecular Weight	Contact for details
Synonyms	4-[5-Methyl-3-phenyl-4-isoxazolyl]benzenesulfonamide-13C2,15N Impurity D; Valdecoxib-13C2,15N Related Compound D; 13C2,15N-Labeled Valdecoxib Impurity D; Isotopically Labeled Valdecoxib Degradant; BMS-347070 Impurity D-13C2,15N; SC-65872 Impurity D (Labeled); 1,2-Benzisoxazolemethanesulfonamide derivative-13C2,15N; Stable Isotope-Labeled COX-2 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Valdecoxib Impurity D-13C2,15N is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and isotopic enrichment. Our quality system is designed to support cGMP and ISO 17034 requirements for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, isotopic purity, chemical purity (by HPLC), and identification (by NMR and MS).

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 99 atom % 15N
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.