Description

Ampicillin Impurity 11 is a specified impurity and degradation product of the β-lactam 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 used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the production and testing of Ampicillin and related drug substances.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Ampicillin API and finished drug products.
• Essential for method development and validation in analytical chemistry, particularly for HPLC and UPLC assays.
• Critical component in stability studies to understand the degradation pathways of Ampicillin under various conditions.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Supports quality assurance/quality control (QA/QC) processes to ensure batch-to-batch consistency and drug safety.
• Valuable for research and development of new synthetic routes and purification processes for β-lactam antibiotics.

Basic Information

Product Name	Ampicillin Impurity 11
CAS No.	281670-45-9
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 Related Compound; Ampicillin Degradant; Ampicillin EP Impurity; Ampicillin USP Impurity; D-(-)-α-Aminobenzylpenicillin Impurity; Penicillin Impurity
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure high purity and identity, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identification, purity (by HPLC), and related substances. We support compliance with ICH Q3A, Q3B, USP, and EP 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 material 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 matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified 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.