Description

Penicillin Impurity 3 CAS NO 76350-36-2 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 penicillin-based pharmaceuticals by serving as a known impurity for method development and validation. It is an essential material for analytical chemists, quality control laboratories, and research scientists working in pharmaceutical development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in penicillin drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability over time.
• Regulatory Compliance and Documentation: Essential for generating data to meet stringent regulatory requirements from agencies like the FDA, EMA, and ICH for drug approval and filing.
• Research and Development: Used in R&D to study the degradation pathways, formation mechanisms, and toxicological profiles of penicillin impurities.
• Calibration of Laboratory Equipment: Acts as a precise calibrant for spectroscopic and chromatographic instruments to ensure accurate analytical measurements.

Basic Information

Product Name	Penicillin Impurity 3
CAS No.	76350-36-2
Molecular Formula	C16H18N2O4S
Molecular Weight	334.39 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Ampicillin Impurity C; D-(-)-α-Aminobenzylpenicillin Impurity; 6-[D(-)-α-Aminophenylacetamido]penicillanic acid; Ampicillin EP Impurity C; Ampicillin Related Compound C; BRL 1341 Impurity.
EINECS	Contact for details

Quality Control

Every batch of Penicillin Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.