Description

Dicloxacillin 13C4 is a stable isotope-labeled analog of the semi-synthetic penicillin antibiotic Dicloxacillin, specifically enriched with four carbon-13 atoms at key molecular positions. This compound is an essential internal standard for the precise and accurate quantification of Dicloxacillin in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and residue analysis. The use of this isotopically labeled standard is critical for ensuring data integrity and meeting stringent regulatory requirements in drug development and quality control.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the LC-MS/MS quantification of Dicloxacillin in plasma, serum, urine, and tissue homogenates for pharmacokinetic and toxicokinetic studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of Dicloxacillin.
• Residue Testing: Enables accurate detection and quantification of Dicloxacillin residues in food-producing animals and environmental samples to ensure food safety and regulatory compliance.
• Clinical Research: Critical for bioanalytical method development and validation in clinical trials assessing the efficacy and safety of Dicloxacillin formulations.
• Forensic and Anti-Doping Analysis: Provides a reliable reference for confirming the presence of Dicloxacillin in forensic toxicology and sports doping control.
• Pharmaceutical Quality Control: Supports impurity profiling and assay validation of Dicloxacillin in active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Product Name	Dicloxacillin 13C4
CAS No.	2140264-78-2
Molecular Formula	C19H17Cl2N3O5S (with four 13C atoms)
Molecular Weight	~ 476.33 (exact mass varies with isotopic enrichment)
Synonyms	(2S,5R,6R)-6-[[[3-(2,6-Dichlorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl-13C4]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Dicloxacillin-13C4; Dicloxacillin (phenyl-13C4); 13C4-Dicloxacillin; Isotopically Labeled Dicloxacillin; Dicloxacillin Internal Standard; Dicloxacillin-13C4 Sodium Salt (if applicable); Dicloxacillin-13C4-d3 (deuterated variants may exist)
EINECS	Contact for details

Quality Control

Every batch of Dicloxacillin 13C4 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing including assay by HPLC, isotopic enrichment by MS, and identification by NMR and IR spectroscopy. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) detailing batch-specific results for purity, isotopic abundance, and residual solvents are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C (refrigerated) or as indicated on the product label or CoA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment (MS)	≥ 99 atom % 13C (at specified positions)
Chemical Purity (NMR)	≥ 95%
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.