Description

Cefdinir Related Compound A (10 mg) (2(R)-2-[(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1Hfuro[3,4-d][1,3]thiazin-2-yl]acetic acid) is a high-purity reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity or degradation product of the third-generation cephalosporin antibiotic, Cefdinir, making it essential for ensuring drug safety and efficacy. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and batch release testing. Supplied as a precisely weighed 10 mg unit, it guarantees consistency and reliability for sensitive chromatographic analyses.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Cefdinir-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to meet ICH Q2(R1) and other regulatory guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Cefdinir to monitor the formation of this specific degradant under various stress conditions.
• Quality Control (QC) Testing: Essential for in-process control and final release testing of Cefdinir batches to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) by characterizing and controlling specified impurities as per ICH Q3B(R2) requirements.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Cefdinir.

Basic Information

Product Name	Cefdinir Related Compound A (10 mg) (2(R)-2-[(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1Hfuro[3,4-d][1,3]thiazin-2-yl]acetic acid)
CAS No.	178422-42-9
Molecular Formula	C18H18N6O6S2
Molecular Weight	478.50 g/mol
Synonyms	(6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Related Compound A; Cefdinir Impurity A; Cefdinir EP Impurity A; Cefdinir USP Related Compound A; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Isomer; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative; Cefdinir δ-3 Isomer
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured and controlled under strict cGMP conditions to ensure identity, purity, and consistency. Each batch is subjected to comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR spectroscopy. Our quality system is designed to meet the rigorous demands of pharmaceutical analysis and regulatory compliance. A comprehensive Certificate of Analysis (CoA) detailing batch-specific results, chromatograms, and traceability is supplied with every unit.

Storage

Preserve in the original 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 must be kept under dry conditions 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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Net Content	10 mg ± 2%

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