Description

Betamethasone Impurity 4 is a specified impurity of the potent corticosteroid Betamethasone, used in pharmaceutical quality control and research. This compound is critical for the development and validation of analytical methods to ensure the purity, safety, and efficacy of Betamethasone drug substances and products. It is an essential reference standard for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments involved in the manufacture of steroid-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betamethasone Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Betamethasone batches meet stringent pharmacopeial (USP, EP, BP) specifications for impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis and purification processes of Betamethasone to minimize the formation of this impurity.

Basic Information

Product Name	Betamethasone Impurity 4
CAS No.	114488-14-1
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 16β-Methyl-9α-fluoroprednisolone; Betamethasone 16β-Epimer Impurity; Betamethasone EP Impurity D; Betamethasone Related Compound D; 16-Epibetamethasone; 16β-Methyl-9α-fluoro-δ1-hydrocortisone
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, HPLC), assay (by HPLC), and related substances. The quality standard aligns with the requirements for pharmaceutical reference standards and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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