Description

Tioconazole Related Compound A (25 Mg) (1-[2,4-Dichloro-β-[(3-Thenyl)-Oxy]Phenethyl]Imidazole Hydrochloride) is a high-purity chemical reference standard critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Tioconazole. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material for the identification and quantification of related substances in Tioconazole API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to ensure accurate impurity detection limits.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to meet pharmacopeial requirements (USP, EP).
• Stability Studies: Employed to monitor degradation products and assess the shelf-life of antifungal formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and synthesis pathway investigation for new antifungal agents.

Basic Information

Product Name	Tioconazole Related Compound A (25 Mg) (1-[2,4-Dichloro-β-[(3-Thenyl)-Oxy]Phenethyl]Imidazole Hydrochloride)
CAS No.	61709-33-9
Molecular Formula	C16H15Cl2N3OS • HCl
Molecular Weight	397.69 g/mol (for free base: 361.28 g/mol)
Synonyms	1-[2,4-Dichloro-β-[(3-thienylmethoxy)phenethyl]]imidazole hydrochloride; Tioconazole Impurity A; Tioconazole Related Substance A; 1-[2-(2,4-Dichlorophenyl)-2-[(3-thienylmethoxy)ethyl]-1H-imidazole hydrochloride; Trosyd Impurity A; UK-20349 Impurity A; (RS)-1-[2,4-Dichloro-β-[(3-thenyloxy)phenethyl]]imidazole hydrochloride
EINECS	Contact for details

Quality Control

Every batch of our Tioconazole Related Compound A is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the exacting standards required for reference materials. A detailed Certificate of Analysis (COA) is provided with each unit, documenting batch-specific results. Our quality commitment aligns with the expectations of GMP and ISO 17034 for reference material producers.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity. 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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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