Description

Cefdinir Impurity 1 Sodium Salt is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the third-generation cephalosporin antibiotic, Cefdinir, enabling precise identification, quantification, and monitoring during drug development and manufacturing. It is essential for analytical chemists, quality assurance laboratories, and research institutions focused on ensuring the purity, safety, and regulatory compliance of Cefdinir API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in pharmaceutical analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical procedures for impurity profiling of Cefdinir.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished dosage formulators to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data for impurity identification and qualification.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and impurity formation mechanisms.

Basic Information

Product Name	Cefdinir Impurity 1 Sodium Salt
CAS No.	66436-47-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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-carboxylate Sodium Salt; Sodium (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-carboxylate; Cefdinir Related Compound; Cefdinir Impurity A Sodium Salt
EINECS	Contact for details

Quality Control

Our Cefdinir Impurity 1 Sodium Salt is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for use as a reference material. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines where applicable.

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 material 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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