Description

Levalbuterol Related Compound F (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl}-4-(Phenylmethoxy)-1,3-Benzenedimethanol) is a high-purity chemical reference standard, critical for analytical and quality control processes. This compound is essential for ensuring the purity, safety, and efficacy of pharmaceutical products, particularly those containing the active pharmaceutical ingredient levalbuterol. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and quality assurance departments for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in levalbuterol drug substances and finished products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing traceable data for impurity identification as per ICH guidelines.
• Stability Studies: Used to assess the degradation pathways and stability of levalbuterol formulations under various conditions.
• Research & Development: Facilitates chemical research into the metabolism, synthesis, and degradation chemistry of β-2 adrenergic agonists.

Basic Information

Product Name	Levalbuterol Related Compound F (30 Mg) (α-[{(1,1-Dimethylethyl)Amino}Methyl}-4-(Phenylmethoxy)-1,3-Benzenedimethanol)
CAS No.	174607-68-2
Molecular Formula	C19H25NO3
Molecular Weight	315.41 g/mol
Synonyms	Levalbuterol Impurity F; (R)-Salbutamol Related Compound F; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol Benzyl Ether; α-[[(1,1-Dimethylethyl)amino]methyl]-4-(phenylmethoxy)-1,3-benzenedimethanol; (R)-α-[(tert-Butylamino)methyl]-4-(benzyloxy)-1,3-benzenedimethanol; Levalbuterol EP Impurity F; Levalbuterol USP Related Compound F
EINECS	Contact for details

Quality Control

Our Levalbuterol Related Compound F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical development and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term stability, consider storage under inert atmosphere or with desiccant.

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%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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