Description

D3-Isomer Cefmenoxime Impurity is a defined stereoisomeric impurity of the third-generation cephalosporin antibiotic, Cefmenoxime. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require precise characterization and quantification of impurities to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the D3-isomer in Cefmenoxime active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of this specific isomer during forced degradation and long-term stability testing of Cefmenoxime formulations.
• Research & Development: Serves as a key reagent in studies investigating the synthesis, metabolism, and degradation pathways of cephalosporin antibiotics.

Basic Information

Product Name	D3-Isomer Cefmenoxime Impurity
CAS No.	126747-52-2
Molecular Formula	C16H17N9O5S3
Molecular Weight	511.56 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (D3-Isomer); Cefmenoxime D3-Isomer; Cefmenoxime Impurity D3; Cefmenoxime Related Compound D3; SCEM Impurity D3; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative (D3-Isomer)
EINECS	Contact for details

Quality Control

Every batch of D3-Isomer Cefmenoxime Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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