Description

Tulobuterol Impurity CAS NO 34356-83-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Tulobuterol, a bronchodilator. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial standards and regulatory submissions.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material (CRM) for the identification and quantification of impurities in Tulobuterol API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Essential for preparing regulatory filings (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed as a marker to track the formation of degradation products in Tulobuterol formulations under various stress conditions.
• Research & Development (R&D): Used in synthetic chemistry research to study the pathways of impurity formation and to develop robust purification processes.
• Pharmacopeial Testing: Applied as a reference standard to verify compliance with monographs from USP, EP, JP, or other pharmacopeias.

Basic Information

Item	Detail
Product Name	Tulobuterol Impurity
CAS No.	34356-83-7
Molecular Formula	C12H16ClNO
Molecular Weight	225.72 g/mol
Synonyms	1-(2-Chloro-1-phenylethyl)-2-(tert-butylamino)ethanol; 2-(tert-Butylamino)-1-(2-chloro-1-phenylethyl)ethanol; Tulobuterol Related Compound; Tulobuterol EP Impurity; Tulobuterol USP Impurity; α-[[(1,1-Dimethylethyl)amino]methyl]-2-chlorobenzenemethanol; (R*,S*)-(±)-2-(tert-Butylamino)-1-(2-chloro-1-phenylethyl)ethanol
EINECS	Contact for details

Quality Control

Every batch of Tulobuterol Impurity (CAS 34356-83-7) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopeial requirements (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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