Description

Betamethasone Enol Aldehyde Z Isomer is a key pharmaceutical intermediate and a specific stereoisomer of the betamethasone molecule. This compound is critical for the synthesis of high-potency corticosteroid APIs, where the precise Z-isomer configuration is essential for achieving the desired biological activity and purity profile. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of steroidal anti-inflammatory drugs.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of Betamethasone and its derivatives (e.g., Betamethasone Dipropionate, Betamethasone Valerate).
• Active Pharmaceutical Ingredient (API) Synthesis: Used in the final stages of manufacturing high-purity corticosteroid APIs for topical creams, ointments, and injectable formulations.
• Process Development & Research: Serves as a reference standard and starting material in pharmaceutical R&D for optimizing synthetic routes and developing new steroidal compounds.
• Analytical Standard: Employed as a certified reference material (CRM) in quality control laboratories for HPLC, GC, or LC-MS method development and impurity profiling.
• Regulatory Filings: Used to generate impurity data and support regulatory submissions (e.g., ANDA, DMF) by characterizing and controlling process-related isomers.

Basic Information

Product Name	Betamethasone Enol Aldehyde Z Isomer
CAS No.	52647-06-0
Molecular Formula	C₂₂H₂₉FO₅
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-Acetaldehyde; (16β)-9-Fluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-Acetaldehyde; Betamethasone 21-Acetaldehyde Z-Isomer; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 21-Acetaldehyde (Z); Betamethasone Enol Ether Aldehyde Z Form; Z-Isomer of Betamethasone Enol Aldehyde
EINECS	Contact for details

Quality Control

Our Betamethasone Enol Aldehyde Z Isomer is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification, to ensure it meets stringent specifications for pharmaceutical intermediate use. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles by HPLC/GC is provided with every shipment, supporting cGMP compliance for our customers.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its light-sensitive and easily oxidized nature, it is recommended to store the material under an inert atmosphere (e.g., nitrogen or argon) for long-term stability, especially after the original container is opened. Keep away from strong oxidizing agents.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Z-Isomer Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5% w/w

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