Description

Cephalonium Dihydrate Standard is a high-purity chemical reference material, essential for accurate analytical and quality control procedures. This compound serves as a critical benchmark for the identification and quantification of Cephalonium in pharmaceutical formulations and research samples. It is primarily required by quality assurance laboratories, research institutions, and manufacturers in the pharmaceutical and veterinary medicine sectors for method validation, calibration, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the assay and impurity testing of Cephalonium API and finished drug products.
• Analytical Method Development & Validation: Serves as the key standard for developing and validating HPLC, UPLC, and other chromatographic methods in QC labs.
• Quality Control & Assurance: Used in routine batch testing to ensure the identity, potency, and purity of Cephalonium meet pharmacopeial specifications (e.g., USP, EP).
• Research & Development: Employed in stability studies, degradation profiling, and metabolic research related to this cephalosporin antibiotic.
• Regulatory Compliance & Documentation: Provides essential traceability and support for regulatory filings with agencies like the FDA and EMA.
• Veterinary Pharmaceutical Analysis: Critical for quality control in the manufacturing of veterinary medicinal products containing Cephalonium.

Basic Information

Product Name	Cephalonium Dihydrate Standard
CAS No.	1385046-35-4
Molecular Formula	C20H20N6O6S2 • 2H2O
Molecular Weight	532.55 g/mol (Dihydrate)
Synonyms	Cephalonium Dihydrate; Cephalonium Standard; (6R,7R)-7-[[(2-Furanylacetyl)amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Dihydrate; Antibiotic 87/312; Ceph-87/312; Cephalonium (Dihydrate); Cephalonium Reference Standard
EINECS	Contact for details

Quality Control

Our Cephalonium Dihydrate Standard is manufactured and certified under strict quality management systems. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data for identity, purity (assay), water content, and related substances by HPLC. The material is qualified against relevant pharmacopeial standards where applicable. We ensure traceability, stability, and consistency for reliable analytical results.

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); ensure the container is sealed immediately after use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.5%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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