Description

Ampicillin EP Impurity C is a high-purity reference standard critical for pharmaceutical quality control and regulatory compliance. This compound is essential for the accurate identification and quantification of related substances in Ampicillin drug substances and finished products, ensuring their safety and efficacy. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Ampicillin.
• Regulatory Compliance: Used to support regulatory filings (e.g., ANDA, NDA) by providing impurity profiles as required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Research: Employed in HPLC, UPLC, and LC-MS studies for the precise analysis and characterization of Ampicillin and its degradation products.
• Stability Studies: A key component in forced degradation and long-term stability studies to monitor impurity formation over time.
• Pharmacopoeial Testing: Used for testing against specifications outlined in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopoeias.
• Manufacturing Process Control: Helps monitor and control impurity levels during the synthesis and purification of Ampicillin active pharmaceutical ingredient (API).

Basic Information

Product Name	Ampicillin EP Impurity C
CAS No.	49841-96-5
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 C; Ampicillin Related Compound C; D-α-Aminobenzylpenicillin; (2S,5R,6R)-6-[(R)-2-Amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Ampicillin EP Impurity C (49841-96-5)
EINECS	Contact for details

Quality Control

Our Ampicillin EP Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopoeial standards.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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