Description

Loratadine Impurity 13 is a specified, high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Loratadine. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a benchmark for identifying and quantifying related substances during manufacturing. It is essential for analytical chemists, quality assurance professionals, and researchers in pharmaceutical development and production who require reliable impurity standards to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine API and finished dosage forms.
• Method Development and Validation: Critical component in developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor batch-to-batch consistency and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Loratadine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates research into the synthesis, metabolism, and degradation pathways of Loratadine.

Basic Information

Product Name	Loratadine Impurity 13
CAS No.	3964-84-9
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; Desloratadine Related Compound C; Loratadine EP Impurity C; Loratadine Related Substance C; Descarboethoxyloratadine; SCH 34117; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
EINECS	Contact for details

Quality Control

Our Loratadine Impurity 13 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) are provided, detailing batch-specific results and traceability. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term stability, consider storage under inert atmosphere if specified.

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)	≥ 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.