Description

Ampicillin Sodium is the sodium salt of the broad-spectrum, β-lactam antibiotic ampicillin. This semi-synthetic penicillin derivative is valued for its enhanced water solubility and stability in solution, making it a critical active pharmaceutical ingredient (API) for injectable formulations. It is essential for manufacturers in the pharmaceutical and veterinary medicine sectors requiring a reliable, high-purity antibiotic base. Ampicillin Sodium CAS NO 69-52-3 is a cornerstone in the production of medications targeting a wide range of bacterial infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable solutions and powders for injection.
• Veterinary Medicine: Formulation of antibiotic treatments for bacterial infections in livestock and companion animals.
• Research & Development: Used as a standard or reagent in microbiological studies and antibiotic resistance research.
• Cell Culture: Application as a selective agent in molecular biology and biotechnology laboratories.
• Bulk Drug Substance: Sourced by contract manufacturing organizations (CMOs) for final dosage form production.
• Combination Therapies: Used in fixed-dose combination products with β-lactamase inhibitors.

Basic Information

Product Name	Ampicillin Sodium
CAS No.	69-52-3
Molecular Formula	C16H18N3NaO4S
Molecular Weight	371.39 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 sodium salt; Sodium ampicillin; Ampicillin sodium salt; D-(-)-α-Aminobenzylpenicillin sodium salt; Binotal; Penbritin; Principen; Totacillin; Amcill-S; Omnipen-N
EINECS	200-709-2

Quality Control

Our Ampicillin Sodium is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards. Certificates of Analysis (COA) documenting comprehensive testing results, including assay, related substances, and microbiological attributes, are provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and maintain stability.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
pH (10% solution)	8.0 - 10.0
Assay (HPLC, anhydrous basis)	96.0% - 102.0%
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 3.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Bacterial Endotoxins	< 0.17 EU/mg
Sterility (where applicable)	Sterile

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