Description

Guanfacine-13C, 15N3 Hydrochloride is a stable isotope-labeled internal standard critical for precise quantitative analysis in bioanalytical research. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based assays, particularly for pharmacokinetic and metabolism studies. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers working with the active pharmaceutical ingredient guanfacine.

Application

• Primary use as an internal standard for the accurate quantification of guanfacine in biological matrices (e.g., plasma, serum, urine) via LC-MS/MS and GC-MS.
• Critical component in pharmacokinetic (PK) and bioequivalence studies for guanfacine formulations, ensuring data integrity for regulatory submissions.
• Enables reliable drug metabolism and disposition (DMPK) research, aiding in metabolite identification and profiling.
• Supports therapeutic drug monitoring (TDM) method development and validation for clinical laboratories.
• Used in forensic and anti-doping analysis for the definitive identification and measurement of guanfacine.
• Facilitates impurity profiling and stability studies of guanfacine drug substances and products.

Basic Information

Product Name	Guanfacine-13C, 15N3 Hydrochloride
CAS No.	1261393-21-8
Molecular Formula	C9H9Cl2N3O (13C, 15N3 labeled)
Molecular Weight	~266.1 g/mol (labeled)
Synonyms	Guanfacine-(phenyl-13C, 15N3) Hydrochloride; 1-(2,6-Dichlorophenyl)acetyl-13C, 15N3-guanidine Hydrochloride; Guanfacine D4 Hydrochloride (common market name); [13C,15N3]-Guanfacine HCl; Isotopically Labeled Guanfacine HCl; Guanfacine Internal Standard; N-Amidino-2-(2,6-dichlorophenyl)acetamide-13C,15N3 Hydrochloride
EINECS	Not applicable for labeled compounds

Quality Control

Every batch of Guanfacine-13C, 15N3 Hydrochloride is manufactured and tested to meet the stringent requirements for isotopic internal standards. Our quality assurance includes rigorous analysis for isotopic purity (enrichment), chemical purity, and structural confirmation. Certificates of Analysis (COA) are provided with each shipment, detailing comprehensive analytical results from techniques including NMR, HPLC, and MS to ensure batch-to-batch consistency and reliability for your critical assays.

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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to expected mass
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Enrichment	≥99 atom % 13C; ≥99 atom % 15N
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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