Description

Cefdinir Impurity 3 (Cefdinir Decarboxy Open Ring Lactone (Mixture Of A And B)) is a specified degradation product and process-related impurity of the broad-spectrum cephalosporin antibiotic, Cefdinir. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Cefdinir active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic analyses in QC/QA laboratories.
• Method Development and Validation: Critical for developing and validating stability-indicating methods to monitor Cefdinir degradation during stability studies.
• Regulatory Compliance and Filing: Supports the identification and quantification of impurities for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used to study the formation pathways of this impurity during Cefdinir synthesis, aiding in process optimization and control.
• Stability Studies: Employed as a marker to assess the forced degradation and long-term stability of Cefdinir under various environmental conditions.
• Academic and Contract Research: Serves as a key reagent in pharmacokinetic, metabolic, and impurity profiling research within academic and CRO settings.

Basic Information

Product Name	Cefdinir Impurity 3 (Cefdinir Decarboxy Open Ring Lactone (Mixture Of A And B))
CAS No.	178949-04-7
Molecular Formula	C14H13N5O5S2
Molecular Weight	395.41 g/mol
Synonyms	Cefdinir Decarboxy Open Ring Lactone; Cefdinir Impurity C; (6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-2-hydroxyiminoacetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 5-Oxide, Lactone; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-8-oxo-3-vinyl-, 5-oxide, (6R,7R)-, Lactone; Cefdinir Lactone Impurity; Cefdinir Related Compound C
EINECS	Contact for details

Quality Control

Our Cefdinir Impurity 3 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents. Our quality commitment ensures the material is suitable for its intended use as a high-purity reference standard in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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