Description

Ceftriaxone Impurity 19 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Ceftriaxone Sodium. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in the production and regulatory compliance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ceftriaxone Sodium API and finished drug products.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopoeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Ceftriaxone.

Basic Information

Product Name	Ceftriaxone Impurity 19
CAS No.	86619-88-7
Molecular Formula	C18H18N8O7S2
Molecular Weight	522.51 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 H; Ceftriaxone EP Impurity H; Ceftriaxone USP Impurity H; 5,6-Dihydro-3-[[(6R,7R)-7-[[(2Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]thio-2-methyl-1,2,4-triazine-5,6-dione
EINECS	Contact for details

Quality Control

Our Ceftriaxone Impurity 19 is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by IR and MS, residual solvent analysis, and specific tests for related substances, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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)	≥ 95.0%
Related Substances (HPLC)	Total Impurities ≤ 5.0% Any Single Unknown Impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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