Description

Olanexidine Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Olanexidine, a potent antiseptic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines and regulatory submissions.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of impurities in Olanexidine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Olanexidine.
• Research & Development (R&D): Serves as a key intermediate or marker in synthetic chemistry research and process optimization for Olanexidine manufacturing.
• Pharmacopeial Testing: Used to verify compliance with purity specifications outlined in pharmacopeias such as USP, EP, or JP.

Basic Information

Product Name	Olanexidine Impurity
CAS No.	147028-65-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1'-(1,6-Hexanediyl)bis(5-(4-chlorophenyl)biguanide) Impurity; Olanexidine Related Compound; Biguanide derivative impurity; 1,6-Bis[N5-(4-chlorophenyl)-N1-biguanido]hexane Impurity; Hexamethylenebis(5-(p-chlorophenyl)biguanide) Impurity; 147028-65-7; Olanexidine HCl Impurity
EINECS	Contact for details

Quality Control

Every batch of Olanexidine Impurity (CAS 147028-65-7) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and research-grade standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with GMP/GLP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture absorption. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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