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PHR1962

Supelco

Salbutamol impurity I

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(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

Empirical Formula (Hill Notation):
C20H27NO3
CAS Number:
56796-66-8
Molecular Weight:
329.43
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

agency

traceable to Ph. Eur. Y0000032

API family

salbutamol, albuterol, albuterol

CofA

current certificate can be downloaded

packaging

pkg of 20 mg

application(s)

pharmaceutical

format

neat

storage temp.

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

InChI key

ICDQPCBDGAHBGG-UHFFFAOYSA-N

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General description

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.

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 LRAB2765 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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.

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pictograms

Exclamation mark
GHS07

signalword

Warning

Hazard Classifications

Acute Tox. 4 Oral - Skin Irrit. 2

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD4590
LRAB2765

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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)
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

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