Description

Olanexidine Impurity is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for ensuring the safety and efficacy of Olanexidine, a potent antiseptic agent, by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Olanexidine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Stability Studies & Forced Degradation: Employed as a marker to track the formation of degradation products during stability testing of Olanexidine formulations.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of commercial Olanexidine batches.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop robust purification processes.

Basic Information

Product Name	Olanexidine Impurity
CAS No.	109435-08-7
Molecular Formula	C17H27Cl2N5
Molecular Weight	372.34 g/mol
Synonyms	1,1'-(1,6-Hexanediyl)bis(5-(4-chlorophenyl)biguanide) Impurity; Olanexidine Related Compound; 1,6-Bis[5-(p-chlorophenyl)biguanido]hexane Impurity; N,N''-Hexane-1,6-diylbis[N'-(4-chlorophenyl)imidodicarbonimidic diamide] Impurity
EINECS	Contact for details

Quality Control

Every batch of our Olanexidine Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including advanced chromatographic purity analysis and structural confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.