Description

Benzylpenicillin Impurity 16 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) pharmaceutical products. It is primarily required by analytical laboratories and quality control units within the pharmaceutical and biotechnology industries. The impurity serves as a vital marker for method development, validation, and stability testing in accordance with ICH guidelines.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specific impurities in Benzylpenicillin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files and investigational new drug applications.
• Stability Studies: Employed as a benchmark to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) during drug shelf-life studies.
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Benzylpenicillin.
• Calibration Standard: Serves as a primary or secondary standard for calibrating analytical instrumentation to ensure accurate and reproducible results.

Basic Information

Product Name	Benzylpenicillin Impurity 16
CAS No.	90962-63-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Penicillin G Impurity 16; (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid related compound; Benzylpenicillin Related Compound 16; Penicillin G Related Substance 16; 90962-63-3; Potential degradation product of Penicillin G
EINECS	Contact for details

Quality Control

Our Benzylpenicillin Impurity 16 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with relevant pharmacopeial and ICH guidelines for impurity standards.

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 Certificate of Analysis. For long-term storage, consider storing desiccated at -20°C. Handle the material under appropriate conditions to prevent contamination or degradation.

Specification

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

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