Description

Cefdinir Impurity P is a high-purity reference standard of a specified impurity associated with the antibiotic Cefdinir. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories and pharmaceutical manufacturers for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefdinir Impurity P in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and over the shelf-life of the drug.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for Cefdinir.

Basic Information

Item	Details
Product Name	Cefdinir Impurity P
CAS No.	2135796-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefdinir Related Compound P; Cefdinir Impurity; Cefdinir EP Impurity P; Cefdinir USP Impurity; (6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Impurity; Antibiotic Impurity; Cephalosporin Impurity
EINECS	Contact for details

Quality Control

Our Cefdinir Impurity P is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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