Description

Protamine 1 is a highly purified, low molecular weight protein derived from fish sperm, primarily salmon, and is identified by CAS NO 94569-30-9. This compound is critically important as a heparin antagonist, used to neutralize the anticoagulant effects of heparin and low molecular weight heparins in medical procedures. It is an essential pharmaceutical active ingredient for manufacturers in the biopharmaceutical and parenteral drug industries, particularly for producing life-saving reversal agents used in cardiovascular surgery, dialysis, and other clinical settings requiring precise blood coagulation control.

Application

• Heparin Reversal Agent: Primary active pharmaceutical ingredient (API) in injectable formulations used to neutralize heparin after cardiopulmonary bypass surgery, vascular surgery, and dialysis.
• Pharmaceutical Intermediates: Serves as a key starting material or intermediate in the synthesis of more complex therapeutic proteins and peptide-based drugs.
• Biochemical Research: Used in laboratory studies of protein-protein interactions, cell biology, and as a tool compound for investigating polycationic effects on cellular membranes.
• Drug Delivery Systems: Investigated for use in forming complexes with nucleic acids (like DNA or siRNA) for non-viral gene delivery and transfection applications.
• Diagnostic Reagents: Component in certain in-vitro diagnostic (IVD) kits and assays that measure heparin levels or related coagulation factors.

Basic Information

Product Name	Protamine 1
CAS No.	94569-30-9
Molecular Formula	Typically a mixture of polypeptides; main components are rich in arginine.
Molecular Weight	~4,000 - 6,000 Da (Average)
Synonyms	Protamine Sulfate (common salt form); Salmine; Clupeine; Iprotimon; Protaminum; Heparin antagonist; Antagonist-H; Delparine; Protasan; 9012-00-4 (CAS for Protamine Sulfate mixture).
EINECS	Contact for details

Quality Control

Our Protamine 1 is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, potency, and safety, suitable for pharmaceutical applications. Certificates of Analysis (COA) are provided with each shipment, detailing results for key parameters such as assay, heparin neutralizing potency, and limits for impurities including histamine and bacterial endotoxins. We support compliance with major pharmacopoeial standards (e.g., USP, EP, JP) and relevant ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation and clumping. For long-term stability, consider storage at 2-8°C.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms
Assay (on dried basis)	Not less than 90.0% (as Protamine)
Heparin Neutralizing Potency	Meets required pharmacopoeial limits
pH (Solution)	6.0 - 7.5
Loss on Drying	≤ 5.0 %
Histamine	≤ 0.2 µg/mg of Protamine
Bacterial Endotoxins	< 5.0 IU/mg
Sterility (if supplied sterile)	Sterile

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