Description

Alclometasone Dipropionate Impurity 4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Alclometasone Dipropionate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in the production of topical corticosteroid medications.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Alclometasone Dipropionate API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to ensure API and drug product purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to monitor the formation and level of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate comprehensive impurity control.
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and to develop improved synthetic processes with lower impurity levels.

Basic Information

Product Name	Alclometasone Dipropionate Impurity 4
CAS No.	76576-24-4
Molecular Formula	C28H37ClO7
Molecular Weight	521.04 g/mol
Synonyms	Alclometasone Dipropionate Related Compound; Alclometasone Impurity 4; 7α-Chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate Impurity; 7α-Chloro-11β-hydroxy-16α-methyl-17α-(1-oxopropoxy)-21-(propionyloxy)pregna-1,4-diene-3,20-dione; Alclometasone Dipropionate EP Impurity; Alclometasone Dipropionate USP Impurity; Alclometasone Dipropionate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Alclometasone Dipropionate Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines and relevant pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. Our commitment to GMP-compliant practices ensures the reliability required for pharmaceutical development and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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