Description

Cefdinir Impurity S is a high-purity chemical reference standard used for analytical and research purposes. 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, quality control laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity S in Cefdinir API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) as per regulatory requirements.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Cefdinir.

Basic Information

Product Name	Cefdinir Impurity S
CAS No.	127770-93-8
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; 7-[2-(2-Aminothiazol-4-yl)-2-(Z)-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic Acid; Cefdinir Related Compound S; Cefdinir δ-3 Isomer; (Z)-Isomer of Cefdinir; Cefdinir Oxime Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefdinir Impurity S is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with ICH Q3A(R2), Q3B(R2) guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. 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%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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