Description

Desmethyl Ofloxacin-D8 Hydrochloride is a deuterium-labeled internal standard critical for ensuring the accuracy and reliability of quantitative analytical methods. This high-purity compound is essential for researchers and quality control laboratories requiring precise measurement of ofloxacin and its metabolites. It is primarily used in the pharmaceutical, contract research organization (CRO), and analytical chemistry sectors for advanced applications such as pharmacokinetic studies and bioanalytical method development.

Application

• Internal Standard for LC-MS/MS: Used as a deuterated internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the accurate quantification of ofloxacin and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical R&D: Supports drug metabolism and pharmacokinetics (DMPK) studies, aiding in the understanding of absorption, distribution, metabolism, and excretion (ADME) profiles.
• Bioanalytical Method Development: Enables the development and validation of robust, precise, and sensitive analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Research: Facilitates therapeutic drug monitoring (TDM) and clinical trial sample analysis for fluoroquinolone antibiotics.
• Metabolite Identification: Assists in the structural elucidation and quantification of drug metabolites in preclinical and clinical studies.
• Quality Control & Assurance: Serves as a critical reference material in pharmaceutical quality control laboratories to ensure batch consistency and purity of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Desmethyl Ofloxacin-D8 Hydrochloride
CAS No.	1217042-59-5
Molecular Formula	C17H11D8FNO4 • HCl
Molecular Weight	~ 387.83 g/mol
Synonyms	9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid-D8 Hydrochloride; Ofloxacin Desmethyl-D8 HCl; Ofloxacin Impurity D-D8 Hydrochloride; (RS)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid-D8 Hydrochloride; Desmethyl Ofloxacin D8 HCl; Ofloxacin-d8 Metabolite Hydrochloride
EINECS	Contact for details

Quality Control

Our Desmethyl Ofloxacin-D8 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and other critical parameters. We adhere to relevant industry standards for reference materials, supporting compliance with GMP, ICH Q2(R2), and other regulatory guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed under inert atmosphere or with desiccant to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
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.