Description

Gentamicin is a broad-spectrum aminoglycoside antibiotic complex produced by *Micromonospora purpurea*. It is a critical active pharmaceutical ingredient (API) valued for its potent bactericidal activity against a wide range of Gram-negative and some Gram-positive bacteria. This compound is essential for manufacturers in the pharmaceutical industry, particularly for formulating injectable solutions, ophthalmic preparations, and topical ointments.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable antibiotic formulations for systemic infections.
• Ophthalmic Preparations: Key component in eye drops and ointments for treating bacterial conjunctivitis and other eye infections.
• Topical Medications: Used in creams, ointments, and wound dressings to prevent or treat skin and soft tissue infections.
• Veterinary Medicine: Employed in formulations for treating bacterial infections in livestock and companion animals.
• Research & Development: Serves as a standard/reference compound in microbiological assays and antibiotic resistance studies.
• Cell Culture: Used in selective media in biotechnology and pharmaceutical research to prevent bacterial contamination.

Basic Information

Product Name	Gentamicin
CAS No.	1403-66-3
Molecular Formula	C21H43N5O7 (for Gentamicin C1)
Molecular Weight	477.60 g/mol (for Gentamicin C1)
Synonyms	Gentamycin; Gentamicin Sulfate (common salt form); Garamycin; Refobacin; Gentamicin C Complex; Gentamicin C1; Gentamicin C1a; Gentamicin C2; 2-Deoxystreptamine antibiotic; O-2-Amino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)-O-[3-deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)]-2-deoxy-D-streptamine
EINECS	215-778-9

Quality Control

Our Gentamicin is produced and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and safety. A detailed Certificate of Analysis (COA) is provided, documenting results for assay, related substances, bacterial endotoxins, sterility (where applicable), and residual solvents. Our quality system is designed to support regulatory filings for markets worldwide.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Description	White or almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
pH (1% solution)	3.5 - 5.5
Assay (HPLC, anhydrous basis)	NLT 590 µg/mg and NMT 630 µg/mg
Related Substances (HPLC)	Individual impurity: NMT 2.0% Total impurities: NMT 5.0%
Water (Karl Fischer)	NMT 15.0%
Sulfate	Contact for details
Bacterial Endotoxins	<0.25 EU/mg
Sterility (for sterile grade)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.