Description

21-Hydroxy Deschloromometasone Furoate (Impurity) is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of corticosteroid-based drug substances and products. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) by enabling accurate identification and quantification of related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis and validation of mometasone furoate and related steroid derivatives.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling & Control: Used to identify, monitor, and quantify this specific impurity during the synthesis and purification of mometasone furoate API.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to meet ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of corticosteroid products.
• Research & Development: Used in synthetic chemistry R&D to study metabolic pathways and to synthesize novel steroid analogs.

Basic Information

Product Name	21-Hydroxy Deschloromometasone Furoate (Impurity)
CAS No.	148596-90-1
Molecular Formula	C₂₇H₃₄O₇
Molecular Weight	470.56 g/mol
Synonyms	21-Hydroxy Deschloromometasone Furoate; 21-Hydroxy-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 17-(2-furoate); 11β,16α,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione 17-(2-furoate); Deschloro-21-hydroxymometasone furoate; Mometasone Furoate Impurity; Mometasone Related Compound; 21-Hydroxy Deschloro Mometasone Furoate
EINECS	Contact for details

Quality Control

Every batch of 21-Hydroxy Deschloromometasone Furoate (Impurity) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and quality assurance requirements.

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 hygroscopic nature, the container must be kept in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

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%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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