Description

Desmethyl Levofloxacin-D8 Hydrochloride is a high-purity, isotopically labeled internal standard critical for advanced analytical chemistry. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities that require definitive analytical reference materials.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise LC-MS/MS quantification of levofloxacin and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the metabolic pathways of fluoroquinolone antibiotics.
• Method Development and Validation: Critical for developing and validating robust, GLP/GMP-compliant analytical methods in regulatory submissions.
• Quality Control in Manufacturing: Applied in the impurity profiling and assay of active pharmaceutical ingredients (APIs) to ensure batch-to-batch consistency.
• Forensic and Anti-Doping Analysis: Supports accurate detection and quantification of fluoroquinolones in forensic toxicology and sports doping control.

Basic Information

Product Name	Desmethyl Levofloxacin-D8 Hydrochloride
CAS No.	1217677-38-7
Molecular Formula	C17H10D8FNO4 • HCl
Molecular Weight	Contact for details
Synonyms	(-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl-d8)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid Hydrochloride; Levofloxacin Desmethyl-D8 HCl; Levofloxacin N-Desmethyl-D8 Hydrochloride; (S)-(-)-Ofloxacin Desmethyl-D8 Hydrochloride; Levofloxacin-d8 Metabolite Standard; Isotopically Labeled Levofloxacin Internal Standard
EINECS	Contact for details

Quality Control

Our Desmethyl Levofloxacin-D8 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic enrichment, and residual solvent content. We ensure compliance with relevant standards for high-purity reference materials, supporting your GLP and GMP requirements.

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 powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
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.