Description

Formoterol Impurity CAS NO 188690-83-7 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 formoterol. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Formoterol Fumarate drug substances and finished dosage forms.
• Analytical Method Development: Used in research and quality control laboratories to develop and validate HPLC, UPLC, and GC methods for impurity detection.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the degradation profile of formoterol-based pharmaceuticals under various stress conditions.
• Pharmacopoeial Testing: Used as a system suitability standard in tests prescribed by USP, EP, or other pharmacopoeias for formoterol-related products.
• Academic & Contract Research: Supports chemical and pharmacological research in academic institutions and CROs (Contract Research Organizations) studying β-2 adrenergic agonists.

Basic Information

Product Name	Formoterol Impurity
CAS No.	188690-83-7
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	Formoterol Related Compound; Formoterol Fumarate Impurity; (R,R)-Formoterol; (R*,R*)-(±)-4-Hydroxy-α-[[[4-(4-methoxyphenyl)-1-piperazinyl]carbonyl]amino]methyl]-1,3-benzenedimethanol; N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(2RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Arformoterol Impurity; Eformoterol Impurity; Oxeze Impurity
EINECS	Contact for details

Quality Control

Every batch of Formoterol Impurity CAS NO 188690-83-7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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)	Any individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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