Description

Betamethasone Impurity 8 is a high-purity chemical 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 utilized by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development and validation.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Betamethasone.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and stability studies.
• Research & Development: Used in metabolic studies, degradation pathway elucidation, and impurity synthesis research for Betamethasone.

Basic Information

Product Name	Betamethasone Impurity 8
CAS No.	1203841-38-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Betamethasone Related Compound 8; Betamethasone EP Impurity 8; Betamethasone USP Impurity 8; 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione Impurity; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione Impurity 8
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 8 is manufactured under strict quality control protocols to ensure the highest standards of purity and identity. Each batch is thoroughly characterized using advanced analytical techniques, including HPLC, GC, and NMR, to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment to support your regulatory and quality needs.

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 stability, consider storage at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH guidelines

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