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Merck
CN

PHR1959

Supelco

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

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About This Item

Empirical Formula (Hill Notation):
C12H19NO2
CAS Number:
96948-64-0
Molecular Weight:
209.28
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

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

SMILES string

N(C(C)(C)C)CC(O)c1ccc(cc1)O

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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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 and EP primary standards, where they are available.

Other Notes

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.
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.
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.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H319,H335

Hazard Classifications

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

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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