Description

Loratadine Impurity 8 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Loratadine. 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 maintaining the integrity of pharmaceutical supply chains.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Loratadine meets pharmacopeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products in Loratadine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization, impurity profiling, and toxicological studies during the drug development process.

Basic Information

Product Name	Loratadine Impurity 8
CAS No.	153200-97-6
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Loratadine Related Compound B; Desloratadine Ethyl Ester Impurity; Loratadine EP Impurity B; Loratadine USP Related Compound B; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-; Lortadine Impurity 8
EINECS	Contact for details

Quality Control

Our Loratadine Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. Our quality standards align with ICH guidelines and support compliance with cGMP requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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