Description

Protamine Sulfate is a highly purified, cationic polypeptide derived from fish sperm, primarily used as a heparin antagonist. Its primary commercial value lies in its critical role in neutralizing the anticoagulant effects of heparin following surgical procedures, particularly cardiovascular surgeries. This essential pharmaceutical ingredient is vital for manufacturers in the biopharmaceutical and hospital supply sectors, ensuring patient safety and effective post-operative care.

Application

• Heparin Reversal Agent: The primary and most critical application is the neutralization of unfractionated heparin following cardiopulmonary bypass surgery and other medical procedures.
• Pharmaceutical Formulation: Used as an active pharmaceutical ingredient (API) in sterile injectable solutions for clinical use.
• Biotechnology Research: Employed in laboratory settings for precipitating nucleic acids and other polyanions due to its strong positive charge.
• Drug Delivery Systems: Investigated for use in forming complexes with negatively charged drugs or genetic material to create controlled-release formulations.
• Cell Culture & Protein Purification: Utilized in specific bioprocessing techniques for its ability to bind and precipitate certain biomolecules.

Basic Information

Product Name	Protamine Sulfate
CAS No.	53597-25-4
Molecular Formula	Mixture of basic polypeptides
Molecular Weight	~5,000 - 10,000 Da (Average)
Synonyms	Protamine Sulphate; Clupeine Sulfate; Salmine Sulfate; Heparin Antagonist; 1H-Imidazolium, 4,5-dihydro-1-methyl-2-nortallquist-1-yl-3-(2-phenylethyl)-, methyl sulfate; Protamini Sulfas
EINECS	Contact for details

Quality Control

Our Protamine Sulfate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and safety. A detailed Certificate of Analysis (COA), documenting key parameters such as nitrogen content, potency, and absence of specific impurities, is provided with each 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). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and potency.

Specification

Item	Specification
Appearance	White or almost white, amorphous or crystalline powder
Identification (IR)	Conforms
Identification (Heparin Neutralization)	Conforms
pH (Solution)	6.0 - 7.0
Nitrogen Content (Dried Basis)	21.0% - 25.0%
Potency (Heparin Neutralizing Activity)	Not less than 90 USP units/mg
Loss on Drying	Not more than 5.0%
Residue on Ignition (Sulfated Ash)	Not more than 1.0%
Heavy Metals	Not more than 20 ppm
Bacterial Endotoxins	Less than 3.5 USP EU/mg
Sterility (if supplied sterile)	Sterile

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