Description

Ophthazin Impurity 2 CAS NO 1044569-46-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in pharmaceutical development, specifically for monitoring and quantifying process-related impurities. It is essential for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation.
• Quality Control (QC) Testing: Used in HPLC, LC-MS, and GC-MS analysis to ensure the purity and safety of active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization.
• Stability Studies: Employed as a marker to track impurity profiles in drug substances and products over time under various storage conditions.
• Process Chemistry Research: Aids in the identification and control of synthetic by-products during the optimization of manufacturing routes.
• Academic & Contract Research: Serves as a key reagent in university and CRO laboratories for pharmacological and toxicological studies.

Basic Information

Product Name	Ophthazin Impurity 2
CAS No.	1044569-46-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ophthazin Related Compound 2; Ophthazin Impurity B; Ophthazin EP Impurity 2; Ophthazin USP Impurity 2; 1044569-46-1; (Chemical name based on structure to be confirmed); Ophthazin Process Impurity
EINECS	Contact for details

Quality Control

Our Ophthazin Impurity 2 is manufactured under strict quality systems to ensure batch-to-batch consistency and reliability for critical analytical work. Each lot undergoes comprehensive characterization and purity verification using advanced spectroscopic and chromatographic techniques. A detailed Certificate of Analysis (COA) is provided, confirming identity, purity, and impurity profile, supporting compliance with ICH guidelines and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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