Description

Halometasone Impurity 3 is a specified impurity of the topical corticosteroid Halometasone, identified by the CAS registry number 80157-55-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for scientists and quality assurance professionals in the pharmaceutical industry who require high-purity materials to ensure the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Halometasone Impurity 3 in Halometasone drug substance and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to establish impurity profiles, set specifications, and ensure batch-to-batch consistency of Halometasone API.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Halometasone formulations.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner Halometasone production.

Basic Information

Product Name	Halometasone Impurity 3
CAS No.	80157-55-7
Molecular Formula	C22H27ClFO5
Molecular Weight	425.90 g/mol
Synonyms	Halometasone Related Compound C; Halometasone EP Impurity C; Halometasone USP Impurity C; 9-Chloro-11β-hydroxy-16β-methyl-3,20-dioxopregna-1,4-dien-21-yl 2-chloroacetate; (11β,16β)-9-Chloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl 2-chloroacetate; 2-Chloro-21-(9-chloro-11β-hydroxy-16β-methyl-3,20-dioxopregna-1,4-dien-21-yloxy)acetate; Halometasone Impurity C (EP); Halometasone Impurity III
EINECS	Contact for details

Quality Control

Our Halometasone Impurity 3 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP, ChP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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