Description

Betamethasone Impurity 7 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 betamethasone-based pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Betamethasone API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways in betamethasone formulations under various storage conditions.
• Research & Development: Used in academic and industrial R&D to study the metabolism, synthesis pathways, and chemical behavior of betamethasone.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine batch release testing.

Basic Information

Product Name	Betamethasone Impurity 7
CAS No.	1249-19-0
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 related compound B; Betamethasone EP Impurity B; Betamethasone USP Related Compound B; 16β-Methyl-9α-fluoro-δ¹-hydrocortisone
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing purity (typically ≥95% by HPLC), identification (IR, NMR), and related substance data 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).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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