Description

Creatinine-Methyl-13C1 is a stable isotope-labeled analog of creatinine, a critical biomarker for renal function. This product is essential for use as an internal standard in mass spectrometry-based assays, ensuring precise and accurate quantification in complex biological matrices. It is primarily required by pharmaceutical R&D laboratories, clinical research organizations, and diagnostic manufacturers for applications in drug metabolism studies, clinical diagnostics, and biomarker validation.

Application

• Internal Standard for LC-MS/MS: Used for the accurate quantification of endogenous creatinine in serum, plasma, and urine samples in clinical and research settings.
• Drug Metabolism & Pharmacokinetics (DMPK): Employed in isotope dilution methods to study the pharmacokinetic profile and renal clearance of drug candidates.
• Clinical Diagnostic Assay Development: Critical component in the development and validation of high-throughput, standardized diagnostic tests for kidney function.
• Biomarker Research: Serves as a stable isotope tracer in metabolic flux studies and research into renal diseases and other physiological conditions.
• Quality Control in Reference Materials: Used to certify and calibrate reference materials and calibrators for clinical chemistry analyzers.
• Forensic & Sports Toxicology: Applied in methods to confirm the authenticity of urine samples and monitor renal function in anti-doping controls.

Basic Information

Product Name	Creatinine-Methyl-13C1
CAS No.	1173022-95-1
Molecular Formula	C4H7N3O (with 13C labeling on the methyl group)
Molecular Weight	114.12 g/mol (for unlabeled form; contact for exact labeled MW)
Synonyms	2-Amino-1-methyl-4,5-dihydro-1H-imidazol-5-one (methyl-13C1); 1-Methyl-13C-hydantoin-2-imide; 13C1-Creatinine; [Methyl-13C]creatinine; Creatinine (methyl-13C); Isotope-labeled creatinine; Stable isotope internal standard creatinine
EINECS	Contact for details

Quality Control

Our Creatinine-Methyl-13C1 is produced under strict quality management systems. Each batch undergoes rigorous analytical testing, including isotopic purity (by NMR or MS), chemical purity (by HPLC), and identity confirmation (by IR and MS). Certificates of Analysis (COA) detailing batch-specific results for isotopic enrichment, chemical purity, and residual solvents are provided. We support compliance with cGMP and ISO 9001 standards for research and diagnostic use.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive). Keep the container 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 crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C
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.