Description

Ceftriaxone Sodium E-Isomer CAS NO 97164-54-0 is a specific stereoisomeric form of the broad-spectrum cephalosporin antibiotic, ceftriaxone sodium. This precise isomer is critical for pharmaceutical research and development, particularly in the study of structure-activity relationships, impurity profiling, and the synthesis of high-purity reference standards. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in antibiotic development, quality control, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the E-isomer impurity in bulk ceftriaxone sodium drug substance.
• Analytical Method Development: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor isomeric purity in active pharmaceutical ingredients (APIs).
• Impurity Profiling and Control: Serves as a key impurity standard to ensure final drug products meet stringent pharmacopeial specifications (e.g., USP, EP, JP) for related substances.
• Research & Development: Utilized in preclinical and clinical research to investigate the pharmacological and toxicological properties of individual ceftriaxone isomers.
• Quality Assurance/Quality Control (QA/QC): Employed in in-house laboratory testing to guarantee the stereochemical purity and consistency of manufactured ceftriaxone sodium batches.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings with agencies like the FDA, EMA, and PMDA.

Basic Information

Product Name	Ceftriaxone Sodium E-Isomer
CAS No.	97164-54-0
Molecular Formula	C18H16N8Na2O7S3 • xH2O
Molecular Weight	Anhydrous: 661.59 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-(2-Aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-[[(2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Sodium Salt (E-Isomer); Ceftriaxone Sodium Isomer E; (Z)-Ceftriaxone Sodium; Ro 13-9904 E-Isomer; E-Ceftriaxone Sodium; Ceftriaxone Impurity E Sodium Salt
EINECS	Contact for details

Quality Control

Our Ceftriaxone Sodium E-Isomer is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and isomer content, spectroscopic identification (IR, NMR), and loss on drying. We provide comprehensive Certificates of Analysis (COA) detailing all test results against relevant in-house or pharmacopeial specifications. Our quality commitment ensures material integrity for your most demanding research and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC, Area %)	≥ 98.0%
Isomeric Purity (E-Isomer Content)	≥ 95.0%
Water Content (KF)	≤ 10.0%
Heavy Metals	≤ 20 ppm
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.