Description

Ceftriaxone-D3 Disodium Salt is a stable isotope-labeled analog of the broad-spectrum cephalosporin antibiotic, ceftriaxone. This high-purity reference material is essential for ensuring accurate and reliable quantification in advanced analytical techniques, providing critical data integrity for research and quality control. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development, pharmacokinetic studies, and regulatory compliance testing.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical quantitative reference in bioanalytical methods for measuring ceftriaxone levels in biological matrices like plasma, serum, and tissue.
• Pharmaceutical Metabolism and Pharmacokinetic (PK/PD) Studies: Enables precise tracking and quantification of the parent drug and its metabolites in in vivo and in vitro studies.
• Method Development and Validation: Used as a certified reference material to develop, optimize, and validate robust analytical methods in compliance with ICH, FDA, and EMA guidelines.
• Quality Control and Assurance: Acts as a benchmark for assessing the purity, potency, and stability of ceftriaxone in active pharmaceutical ingredient (API) and finished drug product batches.
• Clinical Research and Therapeutic Drug Monitoring (TDM): Facilitates accurate measurement of drug concentrations in patient samples to optimize dosing regimens and ensure therapeutic efficacy.

Basic Information

Product Name	Ceftriaxone-D3 Disodium Salt
CAS No.	1132650-38-4
Molecular Formula	C18H15D3N8Na2O7S3
Molecular Weight	661.60 g/mol (anhydrous basis)
Synonyms	(6R,7R)-7-[[(2Z)-(2-Amino-4-thiazolyl)(methoxyimino-D3)acetyl]amino]-3-[[(2-methyl-6-sulfo-1,2,3,4-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Disodium Salt; Ceftriaxone-d3 Sodium Salt; Ceftriaxone (methyl-d3) Disodium Salt; Ro 13-9904-d3 Disodium Salt; 7-[2-(2-Amino-4-thiazolyl)-2-(Z)-(methoxy-d3)iminoacetamido]-3-[[(2-methyl-6-sulfo-5-tetrazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Disodium Salt
EINECS	Contact for details

Quality Control

Our Ceftriaxone-D3 Disodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (D3), and chemical purity. A detailed Certificate of Analysis (COA) is provided, documenting the assay, impurity profile, and residual solvent content to support your regulatory and research requirements.

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 desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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