Description

[15N2,13C2]-Zoledronic Acid is a stable isotope-labeled analog of the potent bisphosphonate drug, zoledronic acid, specifically enriched with nitrogen-15 and carbon-13 at two positions. This compound is an essential internal standard and reference material for the precise quantification and pharmacokinetic studies of zoledronic acid 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 academic institutions engaged in drug metabolism and bioanalytical method development to ensure data accuracy, regulatory compliance, and research reproducibility.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for the development and validation of sensitive and specific LC-MS/MS methods for quantifying zoledronic acid in plasma, serum, and urine.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies by correcting for matrix effects and instrument variability.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to distinguish drug-derived fragments from endogenous compounds.
• Quality Control & Assurance: Acts as a reference standard in pharmaceutical quality control labs to assay active pharmaceutical ingredients (APIs) and finished drug products.
• Clinical Research: Supports therapeutic drug monitoring (TDM) and bioequivalence studies to ensure patient safety and drug efficacy.
• Regulatory Submissions: Provides the traceability and accuracy required for data packages submitted to regulatory agencies such as the FDA and EMA.

Basic Information

Product Name	[15N2,13C2]-Zoledronic Acid
CAS No.	1189694-79-8
Molecular Formula	C513C2H10N15N2O7P2
Molecular Weight	279.04 (for unlabeled form C5H10N2O7P2). Contact for exact labeled MW.
Synonyms	(1-Hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid-15N2,13C2; Zoledronate-15N2,13C2; CGP 42446-15N2,13C2; [15N2,13C2]-Zoledronic Acid; Zometa-15N2,13C2 (labeled analog); Stable Isotope Labeled Zoledronic Acid; (1-Hydroxy-2-(1H-imidazol-1-yl)-1,1-ethanediyl)bis(phosphonic acid)-15N2,13C2
EINECS	Contact for details

Quality Control

Every batch of [15N2,13C2]-Zoledronic Acid is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive characterization using NMR (1H, 13C, 31P), mass spectrometry (MS), and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the isotopic enrichment, purity, and results of all identity and quality tests. Our production adheres to cGMP standards where applicable, ensuring consistency and reliability for critical research and regulatory applications.

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) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % 13C; ≥ 98 atom % 15N
Chemical Purity (by NMR)	≥ 95.0%
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.