Description

Cefdinir Impurity L 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 Cefdinir. It is primarily utilized by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Cefdinir API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in GMP environments to monitor impurity levels.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefdinir.

Basic Information

Product Name	Cefdinir Impurity L
CAS No.	1450758-24-3
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 L; Cefdinir Hydroxyimino Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2Z)-2-(2-amino-4-thiazolyl)-2-(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-, (6R,7R)-
EINECS	Contact for details

Quality Control

Our Cefdinir Impurity L is manufactured under strict quality control protocols to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized using advanced analytical techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment to support your regulatory and quality needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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