Description

Miconazole-D5 Nitrate (Major) is a deuterated internal standard of the antifungal agent Miconazole Nitrate, specifically designed for analytical applications. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in regulated environments. It is primarily used by pharmaceutical research and development laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development and validation in pharmacokinetic and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS: Serves as a critical, non-interfering reference compound for the precise quantification of Miconazole and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmaceutical R&D: Used in method development and validation during drug discovery and development stages for antifungal agents.
• Bioanalytical Testing: Enables accurate and reproducible results in pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) studies.
• Quality Control & Assurance: Employed in QC laboratories to monitor the consistency and purity of Miconazole Nitrate in active pharmaceutical ingredients (APIs) and finished drug products.
• Doping Control & Forensic Analysis: Applicable in specialized testing laboratories for the detection and confirmation of Miconazole in forensic or anti-doping contexts.
• Metabolite Studies: Facilitates research into the metabolic pathways and stability of Miconazole in biological systems.

Basic Information

Item	Detail
Product Name	Miconazole-D5 Nitrate (Major)
CAS No.	1216653-51-8
Molecular Formula	C18H9D5Cl4N2O·HNO3
Molecular Weight	Approx. 504.1 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole-d5 Nitrate; Miconazole-d5 Nitrate; Miconazole Nitrate-d5; Deuterated Miconazole Nitrate; Miconazole (phenyl-d5) Nitrate; Miconazole Internal Standard; Miconazole-d5 (Major) Nitrate; Miconazole Nitrate (phenyl-d5)
EINECS	Contact for details

Quality Control

Every batch of Miconazole-D5 Nitrate (Major) is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity suitable for sensitive analytical techniques. Comprehensive testing includes identity confirmation, assay, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

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. Keep the container in a dry, cool, and well-ventilated place.

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-content)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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