Description

Ampicillin Trimer Trisodium Salt is a high-purity chemical reference standard and key intermediate in pharmaceutical research and development. This compound is essential for analytical method development, quality control, and stability studies related to β-lactam antibiotics. It is primarily utilized by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in the development and validation of penicillin and ampicillin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the HPLC analysis of Ampicillin and related drug substances and finished products.
• Analytical Method Development: Critical for developing and validating chromatographic methods to identify and quantify process-related impurities.
• Quality Control & Assurance: Employed in in-house QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of antibiotic APIs.
• Stability Studies: Used to identify and track degradation products in long-term and accelerated stability testing programs.
• Regulatory Submissions: Serves as a characterized impurity for inclusion in regulatory filings (e.g., FDA, EMA) to support drug safety profiles.
• Research on β-Lactam Degradation: A vital tool for academic and industrial research focusing on the degradation pathways and polymerization of penicillins.

Basic Information

Product Name	Ampicillin Trimer Trisodium Salt
CAS No.	94659-48-0
Molecular Formula	C48H56N9Na3O18S3
Molecular Weight	1220.22 g/mol
Synonyms	Ampicillin Trimer Sodium Salt; Trisodium Ampicillin Trimer; (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 Trimer Trisodium Salt; Ampicillin Trimer; Ampicillin Oligomer (Trimer); 94659-48-0; Sodium Ampicillin Trimer
EINECS	Contact for details

Quality Control

Our Ampicillin Trimer Trisodium Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistency. Each batch is characterized using advanced techniques including HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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