Description

Betamethasone Impurity 35 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Betamethasone, a potent corticosteroid API. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance. The availability of this well-defined impurity standard is essential for method validation and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Betamethasone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control strategies.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and metabolic profiling of Betamethasone.

Basic Information

Product Name	Betamethasone Impurity 35
CAS No.	72559-81-0
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 Impurity G; Betamethasone Related Compound G; 16β-Methyl-9α-fluoro-δ¹-hydrocortisone; 9α-Fluoro-16β-methylprednisolone; Betamethasone EP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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