Description

Cefathiamidine Impurity 3 is a specified impurity of the antibiotic Cefathiamidine, identified by the CAS registry number 1417570-09-2. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories and manufacturers in the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Cefathiamidine drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels against established specifications.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development (R&D): Used in synthetic chemistry and process research to understand and minimize impurity formation during the manufacturing process of Cefathiamidine.

Basic Information

Product Name	Cefathiamidine Impurity 3
CAS No.	1417570-09-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefathiamidine Related Compound 3; Cefathiamidine EP Impurity C; Cefathiamidine USP Impurity; (6R,7R)-7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid impurity; Cefathiamidine Degradation Product; Cefathiamidine Process Impurity
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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