Description

Orbifloxacin Ep Impurity D CAS NO 126458-22-8 is a high-purity reference standard specifically used in the analytical profiling and quality control of the veterinary fluoroquinolone antibiotic, Orbifloxacin. This compound is critical for pharmaceutical manufacturers and testing laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a system suitability standard in chromatographic analyses for the veterinary pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Orbifloxacin active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor and control the level of specified impurities during the manufacturing of Orbifloxacin, ensuring it meets pharmacopoeial standards (e.g., EP, USP).
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), veterinary drug applications, and other regulatory documentation.
• Academic and Contract Research: Supports research into the metabolism, degradation pathways, and analytical chemistry of fluoroquinolone antibiotics.

Basic Information

Item	Detail
Product Name	Orbifloxacin Ep Impurity D
CAS No.	126458-22-8
Molecular Formula	C19H20F3N3O3
Molecular Weight	395.38 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid Impurity D; Orbifloxacin Related Compound D; 7-[(2RS,6RS)-2,6-Dimethyl-4-(methylamino)piperidin-1-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid; Orbifloxacin Impurity D; Orbifloxacin EP Impurity D; Orbifloxacin European Pharmacopoeia Impurity D
EINECS	Contact for details

Quality Control

Every batch of Orbifloxacin Ep Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and consistency, aligning with pharmacopoeial expectations for reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified analytical parameters such as HPLC purity and structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual 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.