PHR1962

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

Properties

• 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

Description

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

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Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H302,H315
• pcodes: P264 - P280 - P301 + P312 - P302 + P352 - P332 + P313 - P362 + P364
• 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