Description

Salbutamol Impurity R is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Salbutamol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Salbutamol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure product purity meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and level of specific impurities in Salbutamol formulations under various stress and storage conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) requirements.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Salbutamol.

Basic Information

Product Name	Salbutamol Impurity R
CAS No.	1221742-55-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albuterol Impurity R; Salbutamol Related Compound R; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol impurity; (RS)-1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol impurity; (±)-α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol impurity
EINECS	Contact for details

Quality Control

Our Salbutamol Impurity R is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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