Description

Ampicillinoic Acid is a key pharmaceutical intermediate and the primary degradation product of the β-lactam antibiotic ampicillin. This compound is of significant importance in the quality control and stability testing of ampicillin-based drugs, ensuring their safety and efficacy. It is primarily needed by manufacturers and research institutions in the pharmaceutical, biotechnology, and analytical chemistry sectors for synthesis, impurity profiling, and reference standard applications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of ampicillin impurities in drug substances and finished products.
• Analytical Chemistry: Serves as a critical marker in High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for stability-indicating assays of ampicillin.
• Impurity Synthesis: Employed in the synthesis and study of related degradation products to understand ampicillin's stability profile.
• Quality Assurance & Control (QA/QC): Essential for validating analytical methods and ensuring compliance with pharmacopoeial standards (USP, EP, BP) for ampicillin.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to trace the degradation pathways of ampicillin in biological and formulation matrices.

Basic Information

Product Name	Ampicillinoic Acid
CAS No.	57457-66-6
Molecular Formula	C16H19N3O4S
Molecular Weight	349.41 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; D-Ampicillinoic Acid; Ampicillin Degradation Product; Ampicillin Open-Lactam Form; Ampicillinic Acid; BRL 2333 Acid; (2S,5R,6R)-6-[(R)-2-Amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Ampicillinoic Acid is produced and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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