PHR1959

Salbutamol Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol, Albuterol Related Compound I, 2-tert-Butylamino-1-(4-hydroxyphenyl)ethanol
• Formule empirique (notation de Hill): C₁₂H₁₉NO₂
• Numéro CAS: 96948-64-0
• Poids moléculaire : 209.28
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to BP 852; traceable to Ph. Eur. Y0000030
• Forme: powder
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 50 mg
• Application(s): pharmaceutical
• Température de stockage: 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
• Clé InChI: JOGFUYPGDLRKHD-UHFFFAOYSA-N

Description

Description générale

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).

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H315,H319,H335
• Conseils de prudence: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Classification des risques: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Organes cibles: Respiratory system
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable