PHR1077

Gentamicina sulfate salt

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: Gentamicin sulfate salt
• Número de CAS: 1405-41-0
• EC Number: 215-778-9
• MDL number: MFCD00270181
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823100
• NACRES: NA.24

Propiedades

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 174; traceable to Ph. Eur. G0200000; traceable to USP 1289003
• API family: gentamicin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: O=S(O)(O)=O.O[C@]1(C)[C@@H]([C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@@](CC[C@H]3N)([C@@H](C)NC)[H])[C@@H](N)C[C@H]2N)OC1)NC.O[C@]4(C)[C@@H]([C@@H](O)[C@@H](O[C@@H]5[C@@H](O)[C@H](O[C@H]6O[C@@](CC[C@H]6N)([C@@H](C)N)[H])[C@@H](N)C[C@H]5N)OC4)NC.O[
• InChI: 1S/C21H43N5O7.C20H41N5O7.C19H39N5O7.H2O4S/c1-9(25-3)13-6-5-10(22)19(31-13)32-16-11(23)7-12(24)17(14(16)27)33-20-15(28)18(26-4)21(2,29)8-30-20;1-8(21)12-5-4-9(22)18(30-12)31-15-10(23)6-11(24)16(13(15)26)32-19-14(27)17(25-3)20(2,28)7-29-19;1-19(27)7-28-18(13(26)16(19)24-2)31-15-11(23)5-10(22)14(12(15)25)30-17-9(21)4-3-8(6-20)29-17;1-5(2,3)4/h9-20,25-29H,5-8,22-24H2,1-4H3;8-19,25-28H,4-7,21-24H2,1-3H3;8-18,24-27H,3-7,20-23H2,1-2H3;(H2,1,2,3,4)/t9-,10-,11+,12-,13+,14+,15-,16-,17+,18-,19-,20-,21+;8-,9-,10+,11-,12+,13+,14-,15-,16+,17-,18-,19-,20+;8-,9+,10-,11+,12-,13+,14+,15-,16+,17+,18+,19-;/m110./s1
• InChI key: RDEIXVOBVLKYNT-HDZPSJEVSA-N

Descripción

General description

Gentamicin is an aminoglycoside complex produced by fermentation of Micromonospora purpurea or M. echinospora. It is used as the sulfate salt. There are three components, each consisting of five basic nitrogens and requiresing five equivalents of sulfuric acid per mole of gentamicin base.
This broad-spectrum antibiotic, is widely used as an active pharmaceutical ingredient (API) with therapeutic potential against both Gram-positive and Gram-negative bacteria.

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 and pharmacopeia primary standards.

Application

Gentamicin Sulfate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using different chromatography techniques. It is also used as a selection agent (gentamicin-resistance gene) in cell culture and molecular biology applications. This product is recommended for use at 50 mg/L.
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.

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.

Biochem/physiol Actions

Modo de acción: La gentamicina produce un error de lectura de codón al unirse a la subunidad ribosómica 30S y bloquear la translocación del peptidil-ARNt del sitio aceptor al sitio donante. El efecto bactericida de la gentamicina en Pseudomonas aeruginosa se ejerce mediante la unión de la gentamicina a la membrana externa, donde desplaza los cationes naturales, desestabiliza la membrana y forma agujeros en la superficie celular.

Espectro antimicrobiano: Incluye bacterias gramnegativas y grampositivas, entre ellas cepas resistentes a la tetraciclina, el cloranfenicol, la canamicina y la colistina, en particular cepas de Pseudomonas, Proteus, Staphylococcus y Streptococcus.

Caution

Sterile solutions should be stored at 2-8°C. Solutions have also been shown to be stable at room temperature and in boiling aqueous buffers of pH 2-14².

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 LRAB3514 in the slot below. This is an example certificate only and may not be the lot that you receive.

Información de seguridad

• pictograms: GHS07
• signalword: Warning
• hcodes: H317
• pcodes: P261 - P272 - P280 - P302 + P352 - P333 + P313 - P362 + P364
• Hazard Classifications: Skin Sens. 1
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable