Description

Betamethasone Valerate EP Impurity I is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient Betamethasone Valerate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of final corticosteroid formulations. It serves as a key reference standard in method development, validation, and routine quality testing. Professionals in pharmaceutical R&D and quality assurance rely on this high-purity impurity for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC and related analytical methods.
• Method Development & Validation: Essential for developing and validating stability-indicating assay methods for Betamethasone Valerate.
• Quality Control & Release Testing: Used in in-process control and final release testing of API batches to monitor and quantify this specific impurity.
• Regulatory Compliance & Filings: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity profiling.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies.
• Pharmacopeial Testing: Used to ensure compliance with monographs from the European Pharmacopoeia (EP) and other international pharmacopeias.

Basic Information

Product Name	Betamethasone Valerate EP Impurity I
CAS No.	2802-10-0
Molecular Formula	C27H37FO6
Molecular Weight	476.58 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate; Betamethasone 17-Valerate Impurity I; Betamethasone Valerate Related Compound I; 21-Desoxybetamethasone 17-valerate; 21-Deoxybetamethasone 17-valerate; 11β,17,21-Trihydroxy-16β-methyl-9-fluoropregna-1,4-diene-3,20-dione 17-valerate
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Valerate EP Impurity I is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile.

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 light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

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

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