Description

Ampicillin Ep Impurity M CAS NO 114977-84-3 is a defined chemical impurity associated with the antibiotic Ampicillin. This compound is critical for pharmaceutical research and development, serving as a reference standard for quality control and regulatory compliance. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and ensuring the purity and safety of Ampicillin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ampicillin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods for impurity detection.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical QC labs to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Stability Studies: Employed to track the formation of degradation impurities in Ampicillin under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Ampicillin.

Basic Information

Product Name	Ampicillin Ep Impurity M
CAS No.	114977-84-3
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; Ampicillin EP Impurity M; Ampicillin Impurity 10 (EP); (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 Ampicillin EP Impurity M is manufactured and tested under strict quality systems. Each batch is characterized and analyzed using advanced techniques like HPLC and NMR to ensure high purity and accurate identification, aligning with pharmacopeial standards (EP, USP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and assay is provided with every shipment.

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)	≥ 95.0%
Water Content	≤ 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.