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Merck
CN

PHR1959

Supelco

沙丁胺醇杂质B

Pharmaceutical Secondary Standard; Certified Reference Material

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别名:
(1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol, Albuterol Related Compound I, 2-tert-Butylamino-1-(4-hydroxyphenyl)ethanol
经验公式(希尔记法):
C12H19NO2
CAS号:
分子量:
209.28
UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to BP 852
traceable to Ph. Eur. Y0000030

形式

powder

CofA

current certificate can be downloaded

包装

pkg of 50 mg

应用

pharmaceutical

储存温度

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

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一般描述

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

应用


  • 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).

分析说明

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

其他说明

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.

附注

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.

推荐产品

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.

象形图

Exclamation mark

警示用语:

Warning

危险声明

危险分类

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

靶器官

Respiratory system

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


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