Tinzaparin Sodium is a low molecular weight heparin (LMWH) and anticoagulant active pharmaceutical ingredient used in the development and manufacture of antithrombotic pharmaceutical formulations. It is the sodium salt of heparin fragments produced through controlled enzymatic depolymerization.
Tinzaparin Sodium is classified as a polymeric pharmaceutical substance rather than a conventional single-molecule API. Its CAS Number is 9041-08-1, and its FDA GSRS UNII is 3S182ET3UA. FDA describes an average molecular-weight range of 5,500–7,500 Da and a mean anti-Xa activity of approximately 100 IU/mg.
Tinzaparin Sodium is obtained by controlled enzymatic depolymerization of heparin derived from porcine intestinal mucosa. The resulting low-molecular-weight heparin contains heterogeneous polysaccharide chains with a defined molecular-weight distribution and anticoagulant activity.
The FDA describes Tinzaparin Sodium as a sodium salt of low molecular weight heparin and states that potency is determined using a biological assay against the International Low Molecular Weight Heparin Standard.
Product Name: Tinzaparin Sodium
CAS Number: 9041-08-1
UNII: 3S182ET3UA
Active Moiety: Tinzaparin
Chemical Class: Low Molecular Weight Heparin
Therapeutic Class: Anticoagulant / Antithrombotic
Substance Class: Polymer
Average Molecular Weight: 5,500–7,500 Da
Mean Anti-Xa Activity: Approximately 100 IU/mg
Unlike conventional synthetic APIs, Tinzaparin Sodium does not have one fixed molecular formula or molecular weight because it consists of a distribution of polysaccharide chains. The FDA-reported molecular-weight distribution is <10% below 2,000 Da, 60–72% between 2,000 and 8,000 Da, and 22–36% above 8,000 Da.
Tinzaparin acts primarily through activation of antithrombin, which enhances inhibition of activated coagulation factors, particularly Factor Xa and thrombin (Factor IIa). This reduces thrombin generation and contributes to inhibition of clot formation.
Tinzaparin therefore belongs to the low molecular weight heparin class of anticoagulant APIs.
Tinzaparin Sodium API is used in the development and manufacture of anticoagulant pharmaceutical formulations.
Its established pharmaceutical applications are associated with prevention and treatment of thromboembolic conditions, including venous thromboembolism. Tinzaparin medicinal products are administered parenterally, and the API is therefore subject to stringent requirements for biological potency, molecular-weight distribution, purity and microbiological quality.
FDA product information describes Tinzaparin Sodium injection as a low molecular weight heparin preparation for subcutaneous use.
Tinzaparin Sodium requires an analytical strategy appropriate for a heterogeneous LMWH polymer rather than the conventional HPLC assay approach used for small-molecule APIs.
Important quality attributes include:
FDA reports that Tinzaparin Sodium potency is determined by biological assay and interpreted as anti-factor Xa activity per milligram.
Swapnroop Drugs and Pharmaceuticals provides quality-focused pharmaceutical API solutions for specialized active ingredients, including complex anticoagulant APIs.
Tinzaparin Sodium requires specialized manufacturing and analytical controls because it is a heterogeneous low molecular weight heparin polymer. Quality evaluation therefore focuses on biological potency, molecular-weight distribution, identity, purity and applicable microbiological controls rather than relying solely on conventional small-molecule assay testing.
Swapnroop supports Tinzaparin Sodium API requirements with specification-focused analytical testing and pharmaceutical documentation.
Tinzaparin Sodium should be handled and packaged using suitable pharmaceutical-grade containers that protect the material from moisture, contamination and inappropriate environmental exposure.
Storage and packaging conditions should follow the approved product specification, stability data and batch-specific Certificate of Analysis. For sterile pharmaceutical applications, additional controls are required throughout processing and filling.
Technical documentation for Tinzaparin Sodium API may include:
Tinzaparin Sodium is a specialized low molecular weight heparin API requiring biological potency testing and control of molecular-weight distribution. Swapnroop focuses on specification-driven pharmaceutical API quality, analytical control and technical documentation.
Tinzaparin Sodium API from Swapnroop is positioned for pharmaceutical customers seeking a quality-focused source of this specialized anticoagulant active pharmaceutical ingredient.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |