Description

Betamethasone Acetate EP Impurity C is a high-purity chemical reference standard specifically used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of betamethasone acetate drug products by enabling the accurate identification and quantification of this specific impurity as per pharmacopeial guidelines. It is an essential material for analytical laboratories, quality assurance departments, and regulatory affairs professionals involved in the development and manufacturing of corticosteroid pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betamethasone Acetate EP Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC testing of betamethasone acetate batches to ensure compliance with strict pharmacopeial limits for related substances as specified in the European Pharmacopoeia (EP) and other international standards.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this impurity over time and under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug master files (DMFs) and marketing authorization applications.
• Research and Development: Utilized in pharmaceutical R&D to understand the degradation pathways and synthesis-related impurities of betamethasone acetate.

Basic Information

Product Name	Betamethasone Acetate EP Impurity C
CAS No.	330157-05-6
Molecular Formula	C24H31FO6
Molecular Weight	434.50 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate Impurity C; Betamethasone Acetate Related Compound C; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 21-acetate Impurity; Betamethasone 21-Acetate Impurity C; EP Impurity C of Betamethasone Acetate; Betamethasone Acetate Process Impurity; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-acetate Impurity
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Acetate EP Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the exacting standards required for a pharmacopeial impurity reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.