Description

Ampicillin Ep Impurity G is a specified impurity of the β-lactam antibiotic Ampicillin, as defined by the European Pharmacopoeia (EP) standards. This high-purity reference standard is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for precise identification, quantification, and monitoring of impurities in Ampicillin API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ampicillin.
• Method Development and Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods in QC labs.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity profiles and specifications.
• Quality Control Testing: Directly used in the routine batch release testing of Ampicillin drug substance and finished products to ensure compliance with EP, USP, or other pharmacopoeial limits.
• Research and Development: Employed in R&D to study the degradation pathways and chemical behavior of Ampicillin.

Basic Information

Product Name	Ampicillin Ep Impurity G
CAS No.	31485-02-6
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-α-Aminobenzylpenicillin; Ampicillin Impurity G (EP); Ampicillin Related Compound G; Ampicillin EP Impurity G; Ampicillin Impurity G (European Pharmacopoeia); Ampicillin Specified Impurity G
EINECS	Contact for details

Quality Control

Our Ampicillin Ep Impurity G is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant pharmacopoeial guidelines.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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