Description

Ampicillin Impurity 16 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, quality assurance departments, and pharmaceutical manufacturers involved in the production and testing of Ampicillin and related penicillin-based drugs to ensure product safety and efficacy.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Ampicillin API and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for antibiotic purity testing.
• Essential for stability studies and forced degradation studies to understand Ampicillin's degradation pathways.
• Used in regulatory compliance and submission to agencies like the FDA, EMA, and ICH for impurity profiling.
• Supports research and development of new synthetic routes and purification processes for β-lactam antibiotics.
• Employed in quality control laboratories for routine batch release testing of Ampicillin.

Basic Information

Product Name	Ampicillin Impurity 16
CAS No.	16477-28-4
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 B; Ampicillin EP Impurity B; D-α-Aminobenzylpenicillin; Ampicillin Degradant; BRL-1341 Impurity; (6R)-6-(α-D-Phenylglycylamino)penicillanic acid
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Impurity 16 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification, to ensure they meet the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with each shipment and is available upon request.

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 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 standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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