Description

Ceftriaxone Impurity 13 CAS NO 473843-58-2 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 widely used antibiotic Ceftriaxone. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The impurity standard supports method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Ceftriaxone API and finished drug products.
• Analytical Method Development and Validation in HPLC, UPLC, and LC-MS systems for impurity profiling.
• Quality Control and Assurance in pharmaceutical manufacturing to meet ICH Q3A/B guidelines.
• Stability Studies to monitor impurity formation under various storage conditions.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA and EMA.
• Research and Development of Ceftriaxone synthesis pathways and degradation studies.

Basic Information

Product Name	Ceftriaxone Impurity 13
CAS No.	473843-58-2
Molecular Formula	C18H18N8O7S3
Molecular Weight	554.57 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-3-[[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Ceftriaxone Related Compound 13; Ceftriaxone EP Impurity 13; Ceftriaxone USP Impurity 13; Ceftriaxone Degradation Product; Ceftriaxone Process Impurity
EINECS	Contact for details

Quality Control

Our Ceftriaxone Impurity 13 is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

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 should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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