Description

Halometasone Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of Halometasone, a potent topical corticosteroid. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and routine testing in compliance with stringent regulatory guidelines. Professionals in pharmaceutical R&D and quality assurance rely on this high-purity standard to maintain supply chain integrity and product consistency.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Halometasone Active Pharmaceutical Ingredient (API) and finished formulations.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, for impurity identification and quantification.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used as a marker to monitor the formation of degradation products in Halometasone under various stress conditions.
• Pharmacopoeial Testing: Aids in testing to meet the specifications of pharmacopoeias like USP, EP, and BP for related substances.
• Research & Development: Facilitates impurity profiling and route scouting during the synthetic process development of Halometasone.

Basic Information

Product Name	Halometasone Impurity 2
CAS No.	136132-00-8
Molecular Formula	C22H27ClFO5
Molecular Weight	425.90 g/mol
Synonyms	21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione; Halometasone Related Compound B; Halometasone EP Impurity B; Halometasone USP Impurity; Halometasone Degradant; 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methyl-1,4-pregnadiene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Halometasone Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and precise impurity profiling requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity levels. We support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopoeial standards (USP, EP) for pharmaceutical impurities.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider desiccants or inert atmosphere conditions to maintain stability and purity.

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 unknown impurity ≤ 0.5%
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.