Description

Fluphenazine B-D-Glucuronide is a high-purity reference standard and metabolite of the antipsychotic drug fluphenazine. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in the development and quality control of neuroleptic medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of fluphenazine and its metabolites in various matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of fluphenazine in preclinical and clinical research.
• Bioanalytical Method Development: Used to develop, validate, and calibrate high-performance liquid chromatography (HPLC), LC-MS/MS, and other analytical methods for therapeutic drug monitoring.
• Impurity Profiling and Characterization: Acts as a known metabolite for identifying and quantifying related substances in active pharmaceutical ingredient (API) and finished drug product testing.
• Toxicology and Safety Assessment: Employed in studies to understand the safety profile and potential toxicological effects of fluphenazine metabolites.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) requiring detailed metabolite identification and quantification.

Basic Information

Product Name	Fluphenazine B-D-Glucuronide
CAS No.	133310-09-5
Molecular Formula	C30H38F3N3O9S
Molecular Weight	673.70 g/mol
Synonyms	Fluphenazine β-D-Glucuronide; Fluphenazine Glucuronide; 2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl β-D-Glucopyranosiduronic Acid; Fluphenazine N-β-Glucuronide; Fluphenazine Glucuronide Metabolite; Fluphenazine B-D-Gluc; Fluphenazine D-Glucuronide
EINECS	Contact for details

Quality Control

Our Fluphenazine B-D-Glucuronide is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity suitable for analytical applications. Each lot undergoes comprehensive testing, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by HPLC. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting the exact specifications and test results. We support compliance with cGMP and ISO guidelines for reference 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 COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.