Description

Betamethasone Impurity 16 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 impurity standard for the quality control and release testing of Betamethasone API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in betamethasone formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and metabolism of betamethasone.
• Quality Assurance/Control (QA/QC): Used for system suitability testing, calibrating equipment, and as a benchmark in routine QC testing of pharmaceutical batches.

Basic Information

Product Name	Betamethasone Impurity 16
CAS No.	1203841-41-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Betamethasone Related Compound 16; Betamethasone EP Impurity 16; Betamethasone USP Impurity 16; Betamethasone Degradation Product; Betamethasone Process Impurity; 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione Impurity; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione Related Substance
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 16 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use under cGMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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