Description

Polymyxin B2 Sulfate is a specific, high-purity component of the polymyxin B antibiotic complex, a critical last-line defense against multidrug-resistant Gram-negative bacterial infections. Its precise isolation and characterization are essential for advanced pharmaceutical research, quality control of polymyxin B products, and the development of novel antimicrobial agents. This material is primarily utilized by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in antibiotic development, pharmacokinetic studies, and reference standard preparation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification, assay, and impurity profiling of polymyxin B sulfate in pharmacopeial testing (USP, EP).
• Antibiotic Research & Development: Used in structure-activity relationship (SAR) studies to understand the contribution of individual polymyxin components to overall efficacy and toxicity.
• Analytical Method Development: Critical for developing and validating precise HPLC, LC-MS, or microbiological assay methods for polymyxin B complex analysis.
• Impurity Characterization: Employed to identify and quantify related substances in polymyxin B bulk drug substances and finished formulations.
• Preclinical & Pharmacokinetic Studies: Used in research to investigate the specific absorption, distribution, metabolism, and excretion (ADME) profile of the B2 component.
• Quality Control (QC) Testing: Essential for in-house QC laboratories in pharmaceutical companies to ensure the consistency and purity of polymyxin B API batches.

Basic Information

Product Name	Polymyxin B2 Sulfate
CAS No.	108965-69-1
Molecular Formula	C56H98N16O13 · xH2SO4
Molecular Weight	~1203.5 (free base)
Synonyms	Polymyxin B2 sulphate; Polymyxin B Component B2; Polymyxin B2; (6R)-6-Methyloctanoyl-Dab-Dab-Dab-D-Leu-D-Phe-L-Thr-Dab-Dab-Thr; Antibiotic Aerosporin component B2; Polyfax component B2
EINECS	Contact for details

Quality Control

Our Polymyxin B2 Sulfate is produced under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets high-purity research-grade standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for critical parameters such as assay, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 10.0%
Assay (on anhydrous basis)	≥ 850 µg/mg

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