Description

N,N'-Dibenzylethylenediammonio [2S-[2Alpha,5Alpha,6Beta(S*)]]-Bis[6-[(Aminophenylacetyl)Amino]-3,3-Dimethyl-7-Oxo-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylate] is a high-purity, complex salt derivative of a penicillin antibiotic, specifically designed for pharmaceutical research and manufacturing. This compound is critical for ensuring the stability and bioavailability of active pharmaceutical ingredients (APIs) in advanced formulations. It is primarily utilized by pharmaceutical R&D laboratories and manufacturers specializing in antibiotic development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification, assay, and impurity profiling of related antibiotic APIs in quality control laboratories.
• Active Pharmaceutical Ingredient (API) Intermediate: Used in the synthesis and purification of specific penicillin-class antibiotics, ensuring correct stereochemistry and potency.
• Analytical Research: Employed in method development and validation for HPLC, LC-MS, and other chromatographic techniques within analytical chemistry and pharmacokinetic studies.
• Microbiological Research: Acts as a precise chemical entity in studies investigating bacterial resistance mechanisms, structure-activity relationships (SAR), and the development of novel β-lactam compounds.
• Formulation Studies: Utilized in pre-formulation and formulation development to study salt forms, stability, and compatibility in solid dosage forms.
• Regulatory Compliance & Documentation: Provides essential material for generating regulatory submission data required by agencies such as the FDA and EMA.

Basic Information

Product Name	N,N'-Dibenzylethylenediammonio [2S-[2Alpha,5Alpha,6Beta(S*)]]-Bis[6-[(Aminophenylacetyl)Amino]-3,3-Dimethyl-7-Oxo-4-Thia-1-Azabicyclo[3.2.0]Heptane-2-Carboxylate]
CAS No.	33276-75-4
Molecular Formula	C58H68N8O10S2
Molecular Weight	1109.35 g/mol
Synonyms	DBED Salt of Ampicillin; N,N'-Dibenzylethylenediamine Ampicillin Salt; Ampicillin Dibenzylethylenediamine Salt; Ampicillin DBED Salt; [2S-[2α,5α,6β(S*)]]-6-[[(Aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N'-dibenzylethylenediamine (2:1); Binotal DBED; Penbritin DBED; Ampibenzyl
EINECS	Contact for details

Quality Control

Every batch of our N,N'-Dibenzylethylenediammonio ampicillin salt is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a pharmaceutical reference standard or intermediate, including testing for identity, purity, and related substances via validated methods. A detailed Certificate of Analysis (COA) is supplied with each shipment, ensuring traceability and compliance with cGMP guidelines and relevant pharmacopeial standards (USP/EP).

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 conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	Contact for details

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