Taurolidine API is a synthetic antimicrobial compound belonging to the thiadiazinane dioxide class. It is chemically derived from taurine and is recognized for broad-spectrum antibacterial and antifungal activity.
Taurolidine is used in antimicrobial applications, particularly in catheter-lock solutions intended to reduce catheter-related bloodstream infections. It is also investigated for additional antimicrobial, anti-inflammatory and antineoplastic properties.
Taurolidine has the molecular formula C₇H₁₆N₄O₄S₂, molecular weight 284.35 g/mol, and CAS number 19388-87-5. FDA's Global Substance Registration System identifies Taurolidine under UNII 8OBZ1M4V3V.
Taurolidine is a synthetic organic antimicrobial active pharmaceutical ingredient. Its chemical structure contains two 1,2,4-thiadiazine 1,1-dioxide rings connected through a methylene bridge.
The compound is known for its ability to interact with microbial endotoxins and exotoxins and is used in antimicrobial catheter-lock applications. Taurolidine in combination with heparin was approved by the U.S. FDA in 2023 for reducing catheter-related bloodstream infections in a defined population of adult patients receiving chronic hemodialysis through a central venous catheter.
| Parameter | Details |
|---|---|
| Generic Name | Taurolidine |
| CAS Number | 19388-87-5 |
| Molecular Formula | C₇H₁₆N₄O₄S₂ |
| Molecular Weight | 284.35 g/mol |
| IUPAC Name | 4-[(1,1-Dioxo-1,2,4-thiadiazinan-4-yl)methyl]-1,2,4-thiadiazinane 1,1-dioxide |
| Chemical Class | Thiadiazinane dioxide |
| Therapeutic Category | Antimicrobial / Antiseptic |
| FDA UNII | 8OBZ1M4V3V |
| PubChem CID | 29566 |
| ChEBI ID | CHEBI:135173 |
| ChEMBL ID | CHEMBL2105420 |
| Appearance | White to light-yellow powder/crystalline solid |
| Stereochemistry | No defined stereocenters |
The molecular identity and physicochemical descriptors are supported by PubChem, Merck Index and FDA-linked substance records.
Taurolidine is primarily associated with antimicrobial catheter-lock therapy.
Its clinically established application includes use in combination with heparin to reduce catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.
Taurolidine has also been investigated for broader antimicrobial and antiseptic applications because of its activity against bacteria and fungi.
Taurolidine exhibits antimicrobial activity through chemical interaction with microbial components, including reactive groups associated with bacterial endotoxins and exotoxins.
The compound can interfere with microbial adhesion and toxin activity, contributing to its antimicrobial and anti-infective effects. Its mechanism is distinct from many conventional antibiotics because taurolidine is not primarily dependent on inhibition of a single microbial enzyme or protein target.
Taurolidine API quality should be controlled using validated pharmaceutical analytical methods.
Typical quality-control parameters include:
Current public commercial reference material reports Taurolidine as a white to light-yellow powder/crystal and gives a reference purity of greater than 98%; this should not be interpreted as a universal pharmaceutical release specification.
Taurolidine API manufacturing involves controlled chemical synthesis followed by purification, crystallization and drying.
Important manufacturing controls may include:
The final material should meet the applicable customer, regulatory and quality specifications before release.
| Property | Value / Description |
|---|---|
| Appearance | White to light-yellow powder to crystal |
| Molecular Formula | C₇H₁₆N₄O₄S₂ |
| Molecular Weight | 284.35 g/mol |
| CAS Number | 19388-87-5 |
| XLogP3-AA | −1.7 |
| Hydrogen Bond Donors | 2 |
| Hydrogen Bond Acceptors | 8 |
| Topological Polar Surface Area | 116 Ų |
| Rotatable Bonds | 2 |
| Defined Stereocenters | 0 |
| Melting Point | Approximately 175°C |
| Water Solubility | Water-solubility value is method/source dependent; quantitative release value not established here |
| Physical State | Solid |
PubChem reports XLogP3-AA −1.7 and TPSA 116 Ų, while TCI currently lists Taurolidine as a solid with a reference melting point of 175°C.
Taurolidine API should be packed in suitable pharmaceutical-grade containers that protect the material from moisture, contamination, light and unsuitable environmental conditions.
Current commercial reference data recommend refrigerated storage at 0–10°C and identify the material as sensitive to light, air and heat. These conditions are supplier-specific and should not automatically be treated as the universal pharmaceutical API storage specification.
The final storage condition should be based on validated stability data and the approved product specification.
Documentation for Taurolidine API may include:
A reliable Taurolidine API Manufacturer in India should provide consistent pharmaceutical-grade quality and appropriate analytical controls for this specialized antimicrobial API.
Key considerations include:
Swapnroop can position Taurolidine as a specialized antimicrobial API supported by controlled manufacturing, quality testing and pharmaceutical documentation.
| Parameter | Details |
|---|---|
| Product Name | Taurolidine |
| CAS Number | 19388-87-5 |
| Molecular Formula | C₇H₁₆N₄O₄S₂ |
| Molecular Weight | 284.35 g/mol |
| IUPAC Name | 4-[(1,1-Dioxo-1,2,4-thiadiazinan-4-yl)methyl]-1,2,4-thiadiazinane 1,1-dioxide |
| Chemical Class | Thiadiazinane dioxide |
| Therapeutic Category | Antimicrobial / Antiseptic |
| FDA UNII | 8OBZ1M4V3V |
| PubChem CID | 29566 |
| Appearance | White to light-yellow powder/crystal |
| Melting Point | Approximately 175°C |
| Storage | Controlled conditions; supplier/stability specification dependent |
| Packaging | Pharmaceutical-grade protective packaging |
The identity, formula, CAS number and molecular weight are confirmed by PubChem and Merck Index.
| Detailed Specification | Correct Value |
|---|---|
| Identification | Conforms – IR / validated identification method |
| Assay (HPLC) | Specification-dependent – no current universal USP/BP/Ph. Eur. numerical API release limit verified |
| Loss on Drying | Specification-dependent |
| Residue on Ignition | Specification-dependent |
| Heavy Metals / Elemental Impurities | Specification-dependent – controlled according to applicable elemental-impurity requirements |
| pH (1% Solution) | Specification-dependent / not established as a universal API release value |
| Individual Impurity | Specification-dependent – controlled by validated related-substances method |
| Total Impurities | Specification-dependent – controlled by validated related-substances method |
| Water Content | Specification-dependent |
| Specific Rotation | N/A – no defined stereocenters |
| Melting Point | Approximately 175°C – current commercial reference value; not verified as a universal pharmacopoeial release criterion |
| Solubility | Quantitative value specification-dependent; do not use a research-grade numerical value as a universal pharmaceutical release specification |
| Appearance | White to light-yellow powder/crystal |
| Particle Size | Specification-dependent where relevant to the intended formulation |
Important: I could verify the chemical identity and the 175°C reference melting point, but I could not verify a current USP/BP/Ph. Eur. monograph providing universal numerical limits for assay, LOD, residue on ignition or individual/total impurities. Therefore those fields should remain specification-dependent rather than using unsupported values.
Taurolidine API Manufacturer in India | Taurolidine API | SDP
Taurolidine API Manufacturer in India offering pharmaceutical-grade Taurolidine for antimicrobial and antiseptic applications with quality testing, documentation and bulk API supply.
Taurolidine API Manufacturer in India
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https://www.sdp.org.in/taurolidine-api-manufacturer-in-india
OG Title:
Taurolidine API Manufacturer in India | Pharmaceutical Grade Taurolidine
OG Description:
Explore pharmaceutical-grade Taurolidine API for antimicrobial and antiseptic applications, supported by quality testing, documentation and bulk API supply.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 1.0% |