Description

Hydralazine-15N4 Hydrochloride is a stable isotope-labeled analog of the antihypertensive agent hydralazine, where four nitrogen atoms are replaced with the 15N isotope. This compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring precise and accurate measurement of hydralazine in complex biological matrices. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical service providers engaged in pharmacokinetic studies, drug metabolism research, and clinical trial support.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of hydralazine in plasma, serum, and urine.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development & Validation: Used as a reference material to develop, optimize, and validate robust analytical methods compliant with GLP and FDA/EMA guidelines.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring and bioequivalence studies during clinical development phases.
• Stable Isotope Dilution Assays (SIDA): Fundamental component in high-precision assays that correct for analyte loss during sample preparation and ionization variability in mass spectrometry.
• Quality Control in Reference Material Production: Acts as a calibrant or system suitability check for laboratories producing certified reference materials (CRMs).

Basic Information

Product Name	Hydralazine-15N4 Hydrochloride
CAS No.	1346603-02-8
Molecular Formula	C8H9ClN4 • HCl (15N4)
Molecular Weight	Approx. 197.06 (unlabeled base) + mass shift for 15N4
Synonyms	1-Hydrazinylphthalazine-15N4 hydrochloride; Hydralazine-15N4 HCl; 1-Hydrazinophthalazine-15N4 monohydrochloride; [15N4]-Hydralazine hydrochloride; Isotopically Labeled Hydralazine HCl; 15N4-Hydralazine HCl; Stable Isotope-Labeled Hydralazine Internal Standard
EINECS	Contact for details

Quality Control

Our Hydralazine-15N4 Hydrochloride is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of isotopic purity and chemical identity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (Atom % 15N), chemical purity (by HPLC), and confirmation of structure (by NMR and MS). We adhere to quality management systems suitable 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 product is hygroscopic (moisture-sensitive) and must be kept 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%
Isotopic Enrichment (Atom % 15N)	≥98%
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.