Description

Colistimethatesodium is a polymyxin antibiotic derivative, specifically the sodium salt of colistimethate. This compound is a critical active pharmaceutical ingredient (API) valued for its potent bactericidal activity against multidrug-resistant Gram-negative pathogens. It is essential for the formulation of injectable and inhalation therapies, primarily serving the pharmaceutical, veterinary medicine, and clinical research sectors.

Application

• Pharmaceutical API: Primary use in the manufacture of injectable antibiotic formulations for systemic infections.
• Inhalation Solutions: Key component in nebulized treatments for chronic respiratory infections, particularly in cystic fibrosis patients.
• Veterinary Medicine: Used in therapeutic products for treating bacterial infections in livestock and companion animals.
• Research & Development: Serves as a reference standard and active compound in microbiological and pharmacological studies.
• Hospital Compounding: Utilized in pharmacy compounding for preparing patient-specific dosage forms where commercial products are unsuitable.

Basic Information

Product Name	Colistimethatesodium
CAS No.	30387-39-4
Molecular Formula	C58H105N16Na5O28S5
Molecular Weight	1749.8 g/mol (approx.)
Synonyms	Colistin Methanesulfonate Sodium; Colistimethate Sodium; Pentasodium Colistimethanesulfonate; Colistin Sulfomethate Sodium; Coly-Mycin M; Polymyxin E Methanesulfonate Sodium; CMS-Na; Colistimetato sódico
EINECS	Contact for details

Quality Control

Our Colistimethatesodium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, potency, and safety, aligning with pharmacopeial standards. A detailed Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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.

Specification

Item	Specification
Appearance	White to slightly yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	Not less than 95.0% (on anhydrous basis)
Water Content (KF)	Not more than 5.0%
pH (1% solution)	6.5 - 8.5
Related Substances (HPLC)	Total impurities: Not more than 5.0% Any single impurity: Not more than 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Bacterial Endotoxins	Less than 0.05 EU/µg
Microbial Enumeration	Complies with EP/USP for non-sterile substances

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