Description

Polytrim Eyedrops is a sterile, multi-dose ophthalmic solution formulated with the active pharmaceutical ingredients trimethoprim and polymyxin B sulfate. This combination provides a broad-spectrum antibacterial action critical for treating and preventing ocular infections. It is an essential product for pharmaceutical manufacturers and compounding pharmacies serving the ophthalmic care sector. The product, identified by CAS NO 53320-96-0, meets stringent requirements for sterility, pH, and isotonicity to ensure patient safety and therapeutic efficacy.

Application

• Primary Use: Formulation of prescription ophthalmic solutions for the treatment of bacterial conjunctivitis and other external eye infections.
• Pharmaceutical Manufacturing: Serves as the active drug substance in the production of sterile eyedrops under current Good Manufacturing Practices (cGMP).
• Hospital & Clinical Pharmacy: Used in institutional settings for preparing bespoke ophthalmic preparations for specific patient needs.
• Veterinary Ophthalmology: Applied in the formulation of antibacterial eye treatments for companion animals and livestock.
• Research & Development: Utilized as a reference standard or active component in ophthalmic drug delivery and efficacy studies.

Basic Information

Item	Details
Product Name	Polytrim Eyedrops
CAS No.	53320-96-0
Molecular Formula	Combination Product (C14H18N4O3 • C56H100N16O17S)
Molecular Weight	Combination Product
Synonyms	Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution; Polymyxin B-Trimethoprim; Antibacterial Eyedrops; Ophthalmic Antibiotic Solution; Polytrim® Ophthalmic Solution; Bacterial Conjunctivitis Drops; TMP-PMX B Ophthalmic
EINECS	Contact for details

Quality Control

Our Polytrim Eyedrops are manufactured in an ISO-certified facility adhering to strict pharmaceutical standards. Each batch undergoes comprehensive testing including sterility, assay (HPLC) for both active ingredients, pH, osmolality, endotoxin levels, and particulate matter analysis to ensure compliance with pharmacopeial monographs. Certificates of Analysis (COA) documenting all release specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Do not freeze. Keep the container in the original carton until use.

Specification

Item	Specification
Description	Clear, colorless to pale yellow sterile solution
Identification (HPLC/IR)	Conforms to standard
Assay (Trimethoprim)	90.0% - 110.0% of label claim
Assay (Polymyxin B Sulfate)	90.0% - 115.0% of label claim
pH	4.0 - 6.0
Osmolality	200 - 350 mOsm/kg
Sterility	Conforms to USP <71>
Endotoxins	< 0.5 EU/mL
Particulate Matter	Conforms to USP <789>

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