Description

Salbutamol Impurity 25 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 this well-characterized impurity standard is essential for maintaining stringent quality control in the production of respiratory medications.

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: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels during stability studies and batch release.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine testing in pharmaceutical QC laboratories to ensure batches meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data for impurity identification and qualification as per ICH Q3A and Q3B guidelines.
• Research & Development: Used in R&D studies to understand the degradation pathways, stability profile, and synthesis-related impurities of Salbutamol.
• Contract Research Organizations (CROs): Utilized by CROs providing analytical testing services to the pharmaceutical industry.

Basic Information

Product Name	Salbutamol Impurity 25
CAS No.	238762-34-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albuterol Impurity 25; Salbutamol Related Compound 25; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol; 3,5-Dihydroxy-α-[(tert-butylamino)methyl]benzyl alcohol; 238762-34-0; tert-Butyl(3,5-dihydroxyphenethyl)amine derivative
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

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 must be kept in a desiccated environment to maintain stability and purity. Ensure the container is sealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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