Description

Ampicillin Ep Impurity I is a specified impurity of the β-lactam antibiotic Ampicillin, as defined by the European Pharmacopoeia (EP) standards. This compound is critical for pharmaceutical manufacturers and analytical laboratories for ensuring the purity, safety, and regulatory compliance of Ampicillin drug substances and finished products. It serves as a vital reference standard in the development and validation of analytical methods, including HPLC and LC-MS. Primary users include quality control (QC) departments, research and development (R&D) teams, and regulatory affairs professionals within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ampicillin impurities in compliance with EP, USP, and ICH guidelines.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods such as HPLC, UPLC, and LC-MS for Ampicillin.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure Ampicillin active pharmaceutical ingredients (APIs) and formulations meet stringent purity specifications.
• Stability Studies: Used to track the formation of degradation products in Ampicillin under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate product quality and control strategy.
• Research on Degradation Pathways: Facilitates research into the chemical stability and degradation mechanisms of Ampicillin.

Basic Information

Product Name	Ampicillin Ep Impurity I
CAS No.	10001-82-8
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 I (EP); Ampicillin Related Compound I; D-α-Aminobenzylpenicillin Impurity I; 6-[D(-)-α-Aminophenylacetamido]penicillanic acid Impurity I
EINECS	Contact for details

Quality Control

Our Ampicillin Ep Impurity I is manufactured and tested under strict quality management systems. Each batch is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) that include data for identification (IR, NMR), assay (HPLC), and related substances. The material is suitable for use as a reference standard in compliance with EP and ICH Q3B(R2) guidelines on impurities in new drug substances.

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 under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

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% Any individual 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.