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Key Documents

PHR1962

Supelco

Salbutamol impurity I

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

(1RS)-2-[(1,1-Dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl]ethanol, 2-tert-Butylamino-1-[3-(hydroxymethyl)-4-benzyloxyphenyl]ethanol

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About This Item

Formule empirique (notation de Hill):
C20H27NO3
Numéro CAS:
Poids moléculaire :
329.43
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. Y0000032

Famille d'API

salbutamol, albuterol, albuterol

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 20 mg

Application(s)

pharmaceutical

Format

neat

Température de stockage

2-8°C

InChI

1S/C20H27NO3/c1-20(2,3)21-12-18(23)16-9-10-19(17(11-16)13-22)24-14-15-7-5-4-6-8-15/h4-11,18,21-23H,12-14H2,1-3H3

Clé InChI

ICDQPCBDGAHBGG-UHFFFAOYSA-N

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Description générale

Salbutamol impurity I is a pharmaceutical impurity of salbutamol, belonging to the class of β2-agonists, widely used for the treatment of acute asthma symptoms and exercise-induced asthma in adults and children.

Application

Salbutamol may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations by chromatographic techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

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 LRAB2765 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.

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

Pictogrammes

Exclamation mark

Mention d'avertissement

Warning

Mentions de danger

Classification des risques

Acute Tox. 4 Oral - Skin Irrit. 2

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


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Certificats d'analyse (COA)

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Consulter la Bibliothèque de documents

Somsak Sirichai et al.
Talanta, 76(5), 1194-1198 (2008-09-02)
Capillary electrophoresis (CE) with UV detection for the simultaneous and short-time analysis of clenbuterol, salbutamol, procaterol, fenoterol is described and validated. Optimized conditions were found to be a 10 mmoll(-1) borate buffer (pH 10.0), an separation voltage of 19 kV
Comparison of isotachophoresis, capillary zone electrophoresis and high-performance liquid chromatography for the determination of salbutamol, terbutaline sulphate and fenoterol hydrobromide in pharmaceutical dosage forms
Ackermans TM, et al.
Journal of Chromatography A, 590(2), 341-353 (1992)

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