Description

Cefdinir Impurity Q is a high-purity chemical 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) Cefdinir. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefdinir API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies & Forced Degradation: Employed in studies to monitor impurity profiles and understand the degradation pathways of Cefdinir under various stress conditions.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for cephalosporin antibiotics.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure Cefdinir API meets stringent pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Cefdinir Impurity Q
CAS No.	2135796-41-5
Molecular Formula	C14H13N5O5S2
Molecular Weight	395.41 g/mol
Synonyms	(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; Cefdinir Related Compound Q; Cefdinir EP Impurity Q; Cefdinir USP Impurity Q; Cefdinir Impurity 7; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-3-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Cefdinir Impurity Q is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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