Description

Cefotaxime Impurity 39 is a designated chemical reference standard used for the analytical profiling and quality control of the third-generation cephalosporin antibiotic, Cefotaxime Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in impurity identification studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Cefotaxime Sodium active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to confirm the identity and control the level of this specific impurity, ensuring batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to identify and quantify degradation products that may form during forced degradation and long-term stability studies of Cefotaxime formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Cefotaxime, supporting improved formulation and packaging strategies.

Basic Information

Product Name	Cefotaxime Impurity 39
CAS No.	66341-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-3-Acetoxymethyl-7-[(2Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefotaxime Impurity K; Cefotaxime Related Compound K; Desacetylcefotaxime Lactone; Cefotaxime δ-3 Isomer; 3-Desacetylcefotaxime Lactone
EINECS	Contact for details

Quality Control

Our Cefotaxime Impurity 39 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), 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 commitment aligns with ICH Q3A/B guidelines for impurities and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent degradation.

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)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.