Description

Benzylpenicillin Impurity 3 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) pharmaceutical products through precise impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The accurate identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Benzylpenicillin (Penicillin G) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against established specifications.
• Stability Studies: Used to track the formation and growth of this specific degradation product during forced degradation and long-term stability studies of penicillin-based formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Facilitates research into the degradation pathways, pharmacokinetics, and toxicological profile of benzylpenicillin and related β-lactam antibiotics.

Basic Information

Product Name	Benzylpenicillin Impurity 3
CAS No.	817553-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Penicillin G Impurity 3; Benzylpenicillin Related Compound 3; (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid impurity; Penicillin G Degradant; BP Imp-3; 817553-80-3
EINECS	Contact for details

Quality Control

Our Benzylpenicillin Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and ICH Q3A/B guidelines on impurities.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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