Description

Cefdinir Impurity 4 is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefdinir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefdinir API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefdinir active pharmaceutical ingredient (API) and drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during Cefdinir synthesis.

Basic Information

Product Name	Cefdinir Impurity 4
CAS No.	51813-38-8
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; 7β-[2-(2-Aminothiazol-4-yl)-(Z)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid; Cefdinir Oxime Impurity; Cefdinir Related Compound D; 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

Our Cefdinir Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity assay, related substances, residual solvents, and other relevant tests. Our quality standards align with ICH Q3A, Q3B, and relevant pharmacopeial guidelines to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.