Description

Olodaterol Impurity 18 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Olodaterol, a long-acting beta2-adrenergic agonist. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for meeting stringent global pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific process-related impurities in Olodaterol HCl API batches.
• Analytical Method Development and Validation: Used as a critical system suitability component in HPLC, UPLC, and LC-MS methods to ensure accuracy, precision, and specificity.
• Stability-Indicating Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for in-house QC laboratories to confirm that Olodaterol drug substance and drug product specifications are met.
• Regulatory Submissions: Provides necessary data for Investigational New Drug (IND), New Drug Application (NDA), and other regulatory filings to demonstrate comprehensive impurity control.
• Research and Development: Supports synthetic route optimization and process chemistry studies by helping to identify and track impurity formation during API synthesis.

Basic Information

Product Name	Olodaterol Impurity 18
CAS No.	2727170-18-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olodaterol Related Compound 18; Olodaterol EP Impurity I; Olodaterol USP Impurity; Olodaterol Process Impurity; 6-Hydroxy-8-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]-2H-1,4-benzoxazin-3(4H)-one isomer; (R,R)-Formoterol Impurity; BI 1744 Impurity
EINECS	Contact for details

Quality Control

Every batch of Olodaterol Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

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. This 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 corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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