Description

Benzylpenicillin Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of benzylpenicillin (penicillin G) and related pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in antibiotic production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific 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 antibiotic analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical manufacturing under GMP guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of benzylpenicillin to understand degradation pathways.
• Research & Development: Utilized in pharmaceutical R&D for studying the metabolism, degradation, and synthesis pathways of penicillin-class antibiotics.

Basic Information

Product Name	Benzylpenicillin Impurity 1
CAS No.	857960-51-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Penicillin G Impurity 1; (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 A; Penicillin G Related Substance 1; 6-APA derivative impurity; Phenylacetyl-6-aminopenicillanic acid impurity; BP Imp-1
EINECS	Contact for details

Quality Control

Every batch of Benzylpenicillin Impurity 1 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, 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 for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at 2-8°C is recommended. Keep the container sealed to protect the contents from moisture.

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%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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