Description

Formoterol Ep Impurity H is a high-purity reference standard specifically used in the analytical profiling and quality control of Formoterol, a long-acting β-adrenoceptor agonist (LABA) medication. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, meet stringent regulatory requirements, and validate analytical methods. It is primarily utilized in research and development, method development, and as a certified reference material for HPLC and LC-MS analysis in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Formoterol Fumarate active pharmaceutical ingredient (API) and its finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC, UPLC, and LC-MS methods for accurate impurity quantification.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) by providing definitive identification and quantification of specified impurities.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Formoterol drug substances and products under various stress conditions.
• Pharmacopoeial Testing: Used to comply with monograph testing requirements in pharmacopoeias such as USP, EP, and BP for impurity profiling.
• Research & Development: Aids in the study of degradation pathways and the synthesis of Formoterol, supporting process chemistry and formulation science.

Basic Information

Product Name	Formoterol Ep Impurity H
CAS No.	1337876-26-2
Molecular Formula	C19H24N2O4
Molecular Weight	344.41 g/mol
Synonyms	N-[2-Hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Formoterol Impurity H; Formoterol Related Compound H; (R*,R*)-(±)-N-[2-Hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide; Ep Impurity H of Formoterol
EINECS	Contact for details

Quality Control

Every batch of Formoterol Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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