Description

Amoxycillinsodiumsterilebp983 is a sterile, high-purity sodium salt of the broad-spectrum β-lactam antibiotic amoxicillin, meeting the British Pharmacopoeia (BP 983) monograph. This pharmaceutical-grade active pharmaceutical ingredient (API) is critical for ensuring the efficacy, safety, and sterility of injectable and other sterile dosage forms. It is primarily required by pharmaceutical manufacturers and compounding facilities engaged in the production of sterile injectable antibiotics, ophthalmic solutions, and other aseptic products.

Application

• Sterile Injectable Formulations: Primary use as the active ingredient in aseptically manufactured intravenous (IV) and intramuscular (IM) antibiotic injections.
• Ophthalmic Preparations: Formulation of sterile eye drops and ointments for treating bacterial conjunctivitis and other ocular infections.
• Veterinary Pharmaceuticals: Manufacturing of sterile injectable solutions for bacterial infections in livestock and companion animals.
• Lyophilized (Freeze-Dried) Products: Production of stable, sterile powder vials for reconstitution prior to parenteral administration.
• Research & Development: Used in microbiological research, clinical trials, and the development of new antibiotic combination therapies.
• Hospital Compounding: Sourcing for pharmacy-based sterile compounding where specific patient doses or formulations are required.

Basic Information

Product Name	Amoxycillinsodiumsterilebp983
CAS No.	4642-77-8
Molecular Formula	C16H18N3NaO5S
Molecular Weight	387.39 g/mol
Synonyms	Amoxicillin Sodium; Sodium Amoxicillin; Amoxycillin Sodium; (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt; D-(-)-α-Amino-p-hydroxybenzylpenicillin sodium salt; BRL-2333 (sodium salt); Clamoxyl Sodium; Larotid Sodium
EINECS	Contact for details

Quality Control

This product is manufactured and tested to comply with the stringent requirements of the British Pharmacopoeia (BP 983) monograph for sterile Amoxicillin Sodium. Our quality assurance system ensures every batch meets specifications for identity, potency, purity, and sterility. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, bacterial endotoxins, sterility, and other critical parameters. Production is conducted under a cGMP (current Good Manufacturing Practice) environment suitable for pharmaceutical APIs.

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 the original sealed container under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Description	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to standard
pH (10% solution)	8.0 - 10.0
Clarity & Color of Solution	Clear, not more intensely colored than reference
Assay (Anhydrous basis)	96.0% - 102.0% (by HPLC)
Water Content (Karl Fischer)	≤ 4.5%
Related Substances (HPLC)	Individual impurity ≤ 1.0%; Total impurities ≤ 3.0%
Bacterial Endotoxins	< 0.25 IU/mg
Sterility Test	Sterile (meets BP test for sterility)

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