Description

Cefotaxime Impurity D is a designated impurity standard used in the pharmaceutical development and quality control of the antibiotic Cefotaxime Sodium. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefotaxime Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurities during the drug manufacturing process.
• Quality Control and Batch Release Testing: Used in routine QC labs to confirm that Cefotaxime Sodium batches meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies and Degradation Profiling: Employed to study the degradation pathways of Cefotaxime and to identify potential degradants formed under various stress conditions.
• Regulatory Submissions and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research and Development: Utilized in synthetic chemistry R&D to understand and minimize the formation of this specific impurity during the API synthesis.

Basic Information

Product Name	Cefotaxime Impurity D
CAS No.	63527-53-7
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-3-[(Acetyloxy)methyl]-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 3-Hydroxymethyl Cefotaxime; Cefotaxime 3-Hydroxymethyl Derivative; Cefotaxime Impurity D (EP); Cefotaxime Related Compound D; (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 72-(Z)-(O-Methyloxime), Acetate (ester)
EINECS	Contact for details

Quality Control

Every batch of Cefotaxime Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality systems are designed to support compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial guidelines.

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 maintain stability and purity. For long-term storage, consider desiccated conditions.

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%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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