Description

Butamirate Impurity 1 is a specified impurity associated with the active pharmaceutical ingredient Butamirate. This compound is critical for pharmaceutical development and manufacturing, where the identification, quantification, and control of impurities are essential for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by pharmaceutical companies, analytical laboratories, and research institutions involved in the synthesis, quality control, and regulatory filing of antitussive medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Butamirate in drug substances and finished products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and GC, to monitor impurity profiles in accordance with ICH guidelines.
• Quality Control and Assurance: Serves as a critical benchmark in QC laboratories to ensure Butamirate batches meet stringent purity specifications and regulatory standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product during forced degradation and long-term stability testing of pharmaceutical formulations.
• Regulatory Submissions: Provides necessary impurity data for regulatory documentation (e.g., CMC sections of FDA, EMA dossiers) to support drug approval processes.
• Research and Development: Used in synthetic chemistry R&D to understand and optimize the Butamirate synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Butamirate Impurity 1
CAS No.	92321-53-4
Molecular Formula	C18H29NO2
Molecular Weight	291.43 g/mol
Synonyms	2-(2-(Diethylamino)ethoxy)ethyl 2-phenylbutyrate; Butamirate Related Compound A; Butamirate EP Impurity A; Butamirate USP Impurity; Butamyrate Impurity 1; 2-Phenylbutyric Acid 2-(2-Diethylaminoethoxy)ethyl Ester; α-Ethylbenzenacetic Acid 2-[2-(Diethylamino)ethoxy]ethyl Ester
EINECS	Contact for details

Quality Control

Our Butamirate Impurity 1 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of related substances and residual solvents. We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, ensuring compliance with current pharmacopeial standards (USP/EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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