Description

Arformoterol Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Arformoterol. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Arformoterol Impurity 25 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Arformoterol formulations.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Arformoterol.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research & Development: Serves as a key reagent in metabolic, pharmacokinetic, and toxicological studies related to Arformoterol.

Basic Information

Product Name	Arformoterol Impurity 25
CAS No.	477552-94-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Arformoterol Related Compound 25; (R,R)-Formoterol Impurity 25; Arformoterol EP Impurity G; Arformoterol USP Impurity; Arformoterol Process Impurity; (R,R)-N-[2-Hydroxy-5-[(1R)-1-hydroxy-2-[[(2R)-4-(4-methoxyphenyl)butan-2-yl]amino]ethyl]phenyl]formamide; Brovana Impurity 25
EINECS	Contact for details

Quality Control

Every batch of Arformoterol Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with ICH Q3A/B and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Avoid exposure to excessive heat and moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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