Description

Ofloxacin-D3 Hydrochloride is a high-purity, isotopically labeled internal standard critical for ensuring analytical accuracy and reliability in quantitative mass spectrometry. This deuterated compound is essential for researchers and quality control laboratories requiring precise measurement and validation of the parent drug, ofloxacin, in complex matrices. It is primarily utilized in pharmaceutical research, bioanalytical method development, and regulatory compliance testing within the life sciences sector.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference standard in bioanalytical assays for ofloxacin in plasma, serum, and tissue samples.
• Pharmaceutical R&D: Facilitates pharmacokinetic (PK) and pharmacodynamic (PD) studies, including drug metabolism and bioavailability assessments.
• Clinical Research: Enables accurate monitoring of drug concentrations in patient samples for therapeutic drug monitoring (TDM) and clinical trial analysis.
• Method Development & Validation: Serves as a critical component in developing and validating robust, regulatory-compliant analytical methods (e.g., following FDA/EMA guidelines).
• Quality Control & Impurity Profiling: Assists in the identification and quantification of process-related impurities and degradants in active pharmaceutical ingredient (API) batches.
• Forensic & Anti-Doping Analysis: Applied in forensic toxicology and sports anti-doping programs for the definitive confirmation of ofloxacin presence.

Basic Information

Product Name	Ofloxacin-D3 Hydrochloride
CAS No.	1173021-78-7
Molecular Formula	C18H17D3FNO4·HCl
Molecular Weight	387.80 g/mol (Hydrochloride salt)
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-d3 Hydrochloride; (±)-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-d3 Hydrochloride; Ofloxacin (methyl-d3) Hydrochloride; DL-8280-d3 Hydrochloride; RU 43280-d3 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of our Ofloxacin-D3 Hydrochloride is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. We provide full traceability and support regulatory submissions with comprehensive documentation. A detailed Certificate of Analysis (COA), including data for isotopic purity (D-content), chemical purity (HPLC), and structural confirmation (NMR, MS), is supplied with each product.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (Titration)	97.0% - 103.0% (as hydrochloride)
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.