Description

Cefoxitin Impurity 6 CAS NO 1422023-32-2 is a characterized impurity of the second-generation cephalosporin antibiotic, Cefoxitin. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require precise impurity profiling to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefoxitin Impurity 6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring adherence to pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability testing of Cefoxitin formulations.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Facilitates studies on the degradation pathways, synthesis impurities, and metabolic profiling of Cefoxitin.

Basic Information

Item	Detail
Product Name	Cefoxitin Impurity 6
CAS No.	1422023-32-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefoxitin Related Compound 6; Cefoxitin EP Impurity 6; Cefoxitin USP Impurity 6; (6R,7S)-3-[(Carbamoyloxy)methyl]-7-methoxy-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 7-Methoxy-3-[(aminocarbonyl)oxy]methyl]-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Impurity 6 of Cefoxitin
EINECS	Contact for details

Quality Control

Every batch of Cefoxitin Impurity 6 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our quality protocols are designed to meet the stringent requirements for pharmaceutical reference standards, with testing typically including identification (IR, NMR), purity assay (HPLC), and control of related substances. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

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 individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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