Description

Ampicillin Ep Impurity M is a high-purity reference standard critical for the analytical profiling and quality control of the antibiotic Ampicillin. This compound serves as a key chromatographic marker for identifying and quantifying related substances in pharmaceutical active pharmaceutical ingredient (API) batches, ensuring compliance with stringent pharmacopeial monographs. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on antibiotic manufacturing and analysis.

Application

• Primary use as a certified reference standard for HPLC and LC-MS analysis in pharmaceutical quality control.
• Identification and quantification of related substances in Ampicillin API according to European Pharmacopoeia (EP) and United States Pharmacopeia (USP) methods.
• Method development and validation for impurity profiling in antibiotic manufacturing processes.
• Calibration of analytical instrumentation used in stability studies and batch release testing.
• Research into the degradation pathways and stability profile of β-lactam antibiotics.
• Supporting regulatory filings and submissions by providing definitive impurity characterization data.

Basic Information

Product Name	Ampicillin Ep Impurity M
CAS No.	62326-82-3
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; Ampicillin Impurity M; Ampicillin Related Compound M; D-Ampicillin; (R)-Ampicillin; Ampicillin EP Impurity M; Ampicillin USP Impurity M
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Ep Impurity M is manufactured and analyzed under strict quality management systems. The material is characterized and qualified using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and suitability as a reference standard. Certificates of Analysis (COA) are provided with each shipment, detailing comprehensive testing results including assay by HPLC, related substances, and spectroscopic confirmation. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.