PHR1079

Tobramycin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Nebramycin Factor 6, O-[3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→4)]-2-deoxy-D-streptamine
• Empirical Formula (Hill Notation): C₁₈H₃₇N₅O₉
• CAS Number: 32986-56-4
• Molecular Weight: 467.51
• Beilstein: 1357507
• EC Number: 251-322-5
• MDL number: MFCD00077885
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823102
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: USP 1667508; traceable to Ph. Eur. T1500000
• API family: tobramycin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O
• InChI: 1S/C18H37N5O9/c19-3-9-8(25)2-7(22)17(29-9)31-15-5(20)1-6(21)16(14(15)28)32-18-13(27)11(23)12(26)10(4-24)30-18/h5-18,24-28H,1-4,19-23H2/t5-,6+,7+,8-,9+,10+,11+,12+,13+,14-,15+,16-,17+,18+/m0/s1
• InChI key: NLVFBUXFDBBNBW-SNGYORCQSA-N

Description

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards. Tobramycin is an aminoglycoside antibiotic effective in treating infections caused by Gram negative bacteria.[1]

Application

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.

Tobramycin may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by high performance liquid chromatography.[2][3][4]

Biochem/physiol Actions

Tobramycin is an aminoglycoside.
Mode of Action: Binds to 70S ribosomal subunit; inhibits translocation; elicits miscoding.
Spectrum of Activity: Gram negative bacteria. Not effective against Enterococci.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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.

To see an example of a Certificate of Analysis for this material enter LRAA5713 in the slot below. This is an example certificate only and may not be the lot that you receive.

Values of analytes vary lot to lot.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H361f
• Precautionary Statements: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3