Description

Benzathine Penicilline G Tetrahydrate is a long-acting, sparingly soluble salt form of the classic β-lactam antibiotic, penicillin G. This formulation is critical for providing sustained therapeutic levels of the antibiotic over an extended period, which is essential for effective treatment regimens. It is a vital active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the production of long-acting injectable antibiotic suspensions.

Application

• Pharmaceutical API: Primary use as the active ingredient in long-acting, repository injectable formulations for intramuscular administration.
• Treatment of Streptococcal Infections: Used in formulations for the prophylaxis and treatment of infections caused by susceptible Gram-positive bacteria, such as streptococci.
• Rheumatic Fever Prophylaxis: A key component in long-term antibiotic regimens to prevent recurrent attacks of rheumatic fever.
• Syphilis Therapy: Employed in specific treatment protocols for syphilis, particularly where long-acting penicillin therapy is indicated.
• Veterinary Medicine: Used in the development of long-acting antibiotic preparations for livestock and companion animals.
• Research & Development: Serves as a reference standard and starting material in pharmaceutical R&D for antibiotic stability and formulation studies.

Basic Information

Product Name	Benzathine Penicilline G Tetrahydrate
CAS No.	41372-02-5
Molecular Formula	C48H56N6O8S2 • 4H2O
Molecular Weight	981.17 g/mol (Tetrahydrate)
Synonyms	Benzathine Benzylpenicillin Tetrahydrate; Penicillin G Benzathine Tetrahydrate; Benzylpenicillin Benzathine Tetrahydrate; N,N'-Dibenzylethylenediamine bis(benzylpenicillin) tetrahydrate; DBED Penicillin G; Long-acting Penicillin; Bicillin (referencing related formulations); Benzathine Penicillin
EINECS	Contact for details

Quality Control

Our Benzathine Penicilline G Tetrahydrate is manufactured and tested to meet exacting standards suitable for pharmaceutical applications. Quality assurance includes rigorous analytical testing against relevant pharmacopoeial monographs (such as USP, EP, or BP) for identity, purity, potency, and related substances. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing all test results and confirming compliance with specified specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. Keep away from excessive heat and incompatible materials.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	96.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	7.0% - 9.0% (Tetrahydrate)
pH (suspension)	5.0 - 7.5
Specific Optical Rotation	+210° to +222° (calculated on anhydrous basis)
Related Substances (HPLC)	Total impurities: NMT 3.0% Any individual impurity: NMT 1.0%
Residual Solvents	Complies with ICH Q3C guidelines
Bacterial Endotoxins	< 0.25 IU/mg (if for injectable use)
Sterility (if required)	Passes test (per USP/EP)

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