Description

Protamine Sulfate is a highly purified, low molecular weight protein derived from fish sperm, primarily used as a critical pharmaceutical agent to reverse the anticoagulant effects of heparin. Its reliable and rapid action makes it an essential component in surgical and clinical settings where precise control of blood coagulation is paramount. This product is vital for manufacturers in the pharmaceutical, biopharmaceutical, and research sectors requiring a high-purity active pharmaceutical ingredient (API) for injectable formulations and advanced therapeutic development.

Application

• Heparin Antidote: Primary use as a reversal agent for heparin and low molecular weight heparin (LMWH) following cardiovascular surgery, dialysis, and other medical procedures.
• Pharmaceutical Formulations: Serves as a key active pharmaceutical ingredient (API) in sterile injectable drugs designed for clinical use.
• Biotechnology & Research: Utilized in cell culture and molecular biology for DNA precipitation and as a stabilizing agent in protein purification processes.
• Drug Delivery Systems: Investigated for use in forming complexes with nucleic acids (like siRNA and DNA) for novel gene delivery and controlled-release applications.
• Diagnostic Reagents: Employed in the formulation of certain in-vitro diagnostic test kits and reagents.

Basic Information

Product Name	Protamine Sulfate
CAS No.	98001-69-5
Molecular Formula	Typically represented as a mixture of polypeptides; primarily composed of arginine-rich proteins.
Molecular Weight	~5,000 - 10,000 Da (Average)
Synonyms	Protamine Sulphate; Salmine Sulfate; Clupeine Sulfate; Protamine, sulfate; Protamine (sulfate); 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-; Heparin antagonist
EINECS	Contact for details

Quality Control

Our Protamine Sulfate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs, ensuring it is suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing for identity, potency, purity, and safety parameters. A Certificate of Analysis (COA) documenting specific results for assay, nitrogen content, pH, clarity of solution, loss on drying, and bacterial endotoxins is provided with every shipment to guarantee traceability and compliance.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Assay (on dried basis)	Not less than 90.0%
Nitrogen Content	21.0% - 25.0%
pH (10 mg/mL solution)	6.0 - 7.5
Loss on Drying	Not more than 5.0%
Clarity of Solution	Conforms
Bacterial Endotoxins	< 10.0 IU/mg

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