Description

Pazufloxacin Impurity 22 (Pazufloxacin-D4) is a deuterated isotopologue of the fluoroquinolone antibiotic pazufloxacin, specifically designed for use as a certified reference material. This compound is essential for ensuring the accuracy and reliability of analytical methods in pharmaceutical development and quality control. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and analytical chemistry industries for method validation, impurity profiling, and quantitative analysis.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification and quantification of related substances in pazufloxacin mesilate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a deuterated internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) methods to improve accuracy and precision.
• Impurity Profiling and Control: Enables precise monitoring and control of specific impurities during the API manufacturing process to ensure compliance with ICH Q3A/B guidelines.
• Metabolite Studies: Acts as a stable isotope-labeled tracer in pharmacokinetic and drug metabolism research to distinguish drug-derived compounds from endogenous substances.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing in GMP environments to verify the purity and consistency of pazufloxacin-based pharmaceuticals.
• Regulatory Submissions: Provides essential data to support regulatory filings (e.g., with FDA, EMA) by demonstrating robust analytical control strategies for impurities.

Basic Information

Product Name	Pazufloxacin Impurity 22 (Pazufloxacin-D4)
CAS No.	1346602-96-7
Molecular Formula	C16H15D4FN4O4
Molecular Weight	349.35 g/mol (for deuterated form)
Synonyms	Pazufloxacin-d4; (-)-Pazufloxacin-d4; (3S)-10-(1-Aminocyclopropyl)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic Acid-d4; Pazufloxacin (D4); Pazufloxacin Impurity D4; Deuterated Pazufloxacin; Pazufloxacin Isotopic Labeled Standard; UNII-7VJ14S8Q8F (deuterated form variant)
EINECS	Contact for details

Quality Control

Every batch of Pazufloxacin Impurity 22 (Pazufloxacin-D4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with the high-purity standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity (by HPLC), isotopic enrichment, and related substances. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Related Substances (HPLC)	Individual unspecified impurity ≤ 0.5% Total impurities ≤ 2.0%
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.