Description

Benzylpenicillin Ep Impurity is a high-purity reference standard critical for pharmaceutical quality control and regulatory compliance. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Benzylpenicillin (Penicillin G) and its derivative drug substances and products. It is primarily utilized by analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and adherence to stringent pharmacopeial guidelines such as EP and USP.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for method development and validation in HPLC and LC-MS analyses.
• Quality Control (QC) Testing: Used as a system suitability standard and for quantifying specified impurities in Benzylpenicillin active pharmaceutical ingredients (APIs) and finished drug products.
• Regulatory Compliance and Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity identification data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation and levels of this specific impurity over time under various storage conditions.
• Pharmacopeial Testing: Essential for conducting tests as per European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs for Penicillin G.
• Research and Development: Used in synthetic chemistry and process chemistry R&D to understand and optimize manufacturing pathways to minimize impurity formation.

Basic Information

Product Name	Benzylpenicillin Ep Impurity
CAS No.	5985-13-7
Molecular Formula	C16H18N2O4S
Molecular Weight	334.39 g/mol
Synonyms	(2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Penicillin G Impurity; Benzylpenicillin Related Compound; Penicillic Acid Derivative; 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Derivative; EP Impurity of Penicillin G; Phenylacetyl-6-APA Derivative
EINECS	Contact for details

Quality Control

Every batch of our Benzylpenicillin Ep Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, and is available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%

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