Description

Tulobuterol Impurity CAS NO 179749-59-8 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, quality control (QC) laboratories, and research institutions involved in method development, validation, and regulatory compliance. The availability of this well-characterized impurity is essential for meeting stringent pharmacopeial standards and regulatory requirements for drug substance and product purity.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify related substances in Tulobuterol API and its finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods like HPLC and UPLC.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Tulobuterol batches comply with specified impurity limits as per ICH Q3A/B guidelines.
• Regulatory Documentation and Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Tulobuterol formulations under various stress conditions.
• Research and Development: Used in R&D to study the metabolic pathways, degradation chemistry, and synthesis pathways of Tulobuterol.

Basic Information

Product Name	Tulobuterol Impurity
CAS No.	179749-59-8
Molecular Formula	C12H16ClNO
Molecular Weight	225.72 g/mol
Synonyms	1-(2-Chloro-1-phenylethyl)-2-(tert-butylamino)ethanol; Tulobuterol Related Compound; Tulobuterol EP Impurity; Tulobuterol USP Impurity; α-[[(1,1-Dimethylethyl)amino]methyl]-2-chloro-benzenemethanol; 2-Chloro-α-[[(1,1-dimethylethyl)amino]methyl]benzenemethanol
EINECS	Contact for details

Quality Control

Every batch of Tulobuterol Impurity (CAS 179749-59-8) is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including confirmation of structure and high purity determination. A detailed Certificate of Analysis (COA) is supplied with each product, containing batch-specific results from advanced techniques such as HPLC, GC, NMR, and MS. Our quality protocols are designed to support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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