Description

Benzylpenicillin Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of benzylpenicillin (penicillin G) by serving as a well-characterized marker in impurity profiling and method validation studies. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers involved in the development and production of penicillin-based antibiotics.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Benzylpenicillin (Penicillin G) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating stability-indicating chromatographic methods in compliance with ICH guidelines.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Stability Studies: Acts as a marker to track degradation pathways and assess the shelf-life of benzylpenicillin formulations under various stress conditions.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research and Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation and behavior of penicillin compounds.

Basic Information

Product Name	Benzylpenicillin Impurity 14
CAS No.	87492-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Penicillin G Impurity 14; (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Impurity; Benzylpenicillin Related Compound 14; 6-APA Derivative Impurity; Penicillanic Acid Impurity; Potential degradation product of Penicillin G
EINECS	Contact for details

Quality Control

Our Benzylpenicillin Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to guarantee traceability and compliance with your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.