Description

Loratadine Ep Impurity F is a high-purity reference standard specifically used in the pharmaceutical quality control process. This compound is critical for the accurate identification, quantification, and monitoring of related substances during the manufacturing and stability testing of the antihistamine drug Loratadine. It is an essential tool for analytical laboratories and pharmaceutical manufacturers committed to ensuring product safety, efficacy, and regulatory compliance. This impurity standard supports method development and validation in accordance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for system suitability and calibration in analytical methods.
• Analytical Method Development & Validation: Crucial for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Loratadine.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to quantify and control the level of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products.
• Stability Studies: Employed to track the formation and increase of Loratadine Ep Impurity F over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Loratadine Ep Impurity F
CAS No.	125743-80-8
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 Impurity F; Loratadine Related Compound F; Desloratadine EP Impurity F; 11-(1-Methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-8(9H)-one; Loratadine Degradation Product; Loratadine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Loratadine Ep Impurity F is manufactured and analyzed under strict quality management systems. The product is characterized and qualified using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure identity, purity, and stability. We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, ensuring traceability and compliance with relevant pharmacopeial standards (EP, USP) and ICH guidelines. Our commitment is to supply reference materials that meet the exacting requirements of pharmaceutical quality control laboratories.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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