PHR1959

Salbutamol Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol, Albuterol Related Compound I, 2-tert-Butylamino-1-(4-hydroxyphenyl)ethanol
• Empirical Formula (Hill Notation): C₁₂H₁₉NO₂
• CAS Number: 96948-64-0
• Molecular Weight: 209.28
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 852; traceable to Ph. Eur. Y0000030
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 50 mg
• application(s): pharmaceutical
• storage temp.: 2-8°C
• InChI: 1S/C12H19NO2/c1-12(2,3)13-8-11(15)9-4-6-10(14)7-5-9/h4-7,11,13-15H,8H2,1-3H3
• InChI key: JOGFUYPGDLRKHD-UHFFFAOYSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Application

• Salbutamol Impurity B Analysis in Pharmaceutical Products: Utilizing advanced chromatographic techniques, researchers have developed validated methods for the precise identification and quantification of Salbutamol Impurity B in pharmaceutical formulations. This critical quality control measure ensures the safety and efficacy of bronchodilator medications, adhering to stringent regulatory standards (Kondra et al., 2023).


• Development of Analytical Standards for Salbutamol Impurity B: The quantification of Salbutamol Impurity B using achiral supercritical fluid chromatography represents a significant advancement in the field of pharmaceutical impurities identification. This method provides a robust, efficient, and reproducible approach for monitoring the stability and purity of salbutamol-based therapies, contributing to enhanced patient safety (Dispas et al., 2017).


• Research on Salbutamol Degradation Products: A stability-indicating RP-HPLC method has been developed for the simultaneous determination of Salbutamol Impurity B and other related substances in nasal solutions. This method is crucial for understanding the degradation pathways of salbutamol, thereby assisting in the development of more stable and effective bronchodilator formulations (Kasawar & Farooqui, 2010).

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3289 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H315,H319,H335
• pcodes: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• target_organs: Respiratory system
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable