Description

Cefradine Ep Impurity D CAS NO 1147512-79-5 is a high-purity reference standard used for the analytical profiling and quality control of the antibiotic Cefradine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Cefradine Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity data required for drug master files (DMFs), Common Technical Documents (CTDs), and pharmacopoeial monographs (USP, EP).
• Stability Studies & Forced Degradation: Used to monitor impurity profiles in stability testing programs to determine shelf-life and storage conditions for Cefradine formulations.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure each batch of Cefradine API or formulation meets predefined purity specifications and impurity limits.
• Research on Degradation Pathways: Aids in research to understand the formation, behavior, and control of this specific impurity during synthesis and storage.

Basic Information

Product Name	Cefradine Ep Impurity D
CAS No.	1147512-79-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2R)-Amino(cyclohexa-1,4-dien-1-yl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cephradine Impurity D; Cefradine Impurity D; Cephradine EP Impurity D; Cefradine Related Compound D; Cephradine Related Compound D
EINECS	Contact for details

Quality Control

Our Cefradine Ep Impurity D is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by high-resolution chromatographic techniques (HPLC, UPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant pharmacopoeial guidelines.

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 product 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 (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 single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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