Description

Loratadine Impurity 15 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antihistamine drug, Loratadine. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Loratadine Impurity 15 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Loratadine API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Loratadine during synthesis and formulation processes.

Basic Information

Item	Details
Product Name	Loratadine Impurity 15
CAS No.	38093-13-9
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 EP Impurity C; Loratadine Related Compound C; Desloratadine Carboxylic Acid; 4-(8-Chloro-5-oxo-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine-4-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results against established in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures the material's suitability for its intended use as a high-grade reference standard.

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), in a dry environment. The container should be kept securely sealed to protect the integrity of the material.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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