Description

Cefoperazone Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefoperazone by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and manufacturers of active pharmaceutical ingredients (APIs) who require precise impurity identification and quantification.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Cefoperazone Sodium API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for accurately detecting and quantifying this specific impurity.
• Stability Studies & Forced Degradation: Employed to identify and track the formation of this impurity in Cefoperazone under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and supporting the establishment of justified specification limits.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Cefoperazone, leading to improved formulation and storage strategies.
• Calibration of Analytical Instruments: Serves as a precise calibrant to ensure the accuracy and reliability of analytical equipment used in pharmaceutical analysis.

Basic Information

Product Name	Cefoperazone Impurity 18
CAS No.	68779-10-2
Molecular Formula	C25H27N9O8S2
Molecular Weight	645.67 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]-2-phenylacetyl]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; Cefoperazone Related Compound; Cefoperazone EP Impurity; Cefoperazone USP Impurity; Cefobid Impurity; Cefoperazone Degradant; 1-[[(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]sulfanyl]-1-methyl-1H-tetrazol-5-ium-4-ethyl-2,3-dioxopiperazine-1-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Cefoperazone Impurity 18 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines for impurities. Our quality commitment supports your regulatory and research requirements.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.