Description

Cefdinir Impurity I is a high-purity reference standard specifically identified and characterized for pharmaceutical analysis. 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 regulatory bodies for method development, validation, and routine quality control testing. The precise identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Cefdinir and its related substances.
• Method Development & Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing of Cefdinir API to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identification and control strategies.
• Stability Studies: Employed as a marker to track impurity formation in Cefdinir drug products under various storage conditions over time.
• Research & Development (R&D): Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Cefdinir Impurity I
CAS No.	1450758-22-1
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-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefdinir Impurity A; Cefdinir Related Compound A; Cefdinir δ-2 Isomer; (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 I is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR) to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccant in the container.

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% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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