Description

Ampicillin Ep Impurity J CAS NO 6489-58-3 is a specified impurity of the broad-spectrum β-lactam antibiotic, Ampicillin. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require precise impurity profiling to ensure drug safety and regulatory compliance with pharmacopeial standards such as EP and USP.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Ampicillin API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC) for stability-indicating assays.
• Essential for pharmacopeial compliance testing (EP, USP, BP) to meet stringent regulatory requirements for impurity limits.
• Used in stability studies to monitor degradation pathways and establish shelf-life for Ampicillin products.
• Supports research and development of Ampicillin synthesis processes to understand and minimize impurity formation.
• Vital for quality control laboratories in pharmaceutical companies and contract research organizations (CROs).

Basic Information

Product Name	Ampicillin Ep Impurity J
CAS No.	6489-58-3
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 J; Ampicillin Related Compound J; D-α-Aminobenzylpenicillin Impurity J; EP Impurity J of Ampicillin; (6R)-6-(α-D-Phenylglycylamino)penicillanic acid impurity J
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Ep Impurity J is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the exacting standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified purity criteria, typically ≥95% (HPLC).

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.