1289003

Gentamicina sulfate salt

United States Pharmacopeia (USP) Reference Standard

• Sinónimos: Gentamicin sulfate salt, Gentamicin C complex sulfate.
• Número CAS: 1405-41-0
• PubChem Substance ID: 329749933
• UNSPSC Code: 41116107
• NACRES: NA.24
• EC Number: 215-778-9

Propiedades

• grade: pharmaceutical primary standard
• agency: USP
• API family: gentamicin
• form: powder
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat
• 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 sulfate is a broad-spectrum aminoglycoside antibiotic derived from Micromonospora species. It binds irreversibly to the 30S ribosomal subunit, causing misreading of mRNA and inhibition of protein synthesis. The USP standard is used in microbiological assays and chromatographic analyses of gentamicin-containing products.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Application

Gentamicin sulfate USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia.
Also, for use with USP monographs such as:

• Gentamicin Sulfate Cream
• Gentamicin Sulfate Ointment
• Gentamicin Sulfate Ophthalmic Ointment
• Gentamicin Sulfate Ophthalmic Solution
• Gentamicin Sulfate and Betamethasone Valerate Topical Solution
• Gentamicin Sulfate and Betamethasone Acetate Ophthalmic Solution
• Gentamicin Sulfate and Betamethasone Valerate Otic Solution
• Gentamicin and Prednisolone Acetate Ophthalmic Ointment

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.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of the USP Biologics program.

Legal Information

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Disclaimer

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.

Información de seguridad

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