- Raw materials
- Diagnostic agents
- Isosulfan blue
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Isosulfan blue API Manufacturers & Suppliers
4 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
Employees: 25
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Isosulfan blue | CAS No: 748080-29-7 | GMP-certified suppliers
A medication that serves as a synthetic visual lymphatic imaging agent for diagnosing and evaluating lymphedema, lymphatic disorders, and lymph node involvement in oncology settings.
Therapeutic categories
Primary indications
- Isosulfan Blue is a synthetic visual lymphatic imaging agent
- Isosulfan blue upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection
- It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities
- Chyluria, chylous ascites or chylothorax
Product Snapshot
- Isosulfan blue is an injectable solution formulated for subcutaneous administration
- It is used primarily as a visual lymphatic imaging agent in lymphography related to lymphedema, chylous disorders, and lymph node involvement in neoplastic conditions
- Isosulfan blue is approved for use in the US and Canadian regulatory markets
Clinical Overview
Pharmacodynamically, after subcutaneous administration, isosulfan blue binds to serum proteins and is selectively taken up by lymphatic vessels. This results in the visual delineation of lymphatic pathways by the intense blue coloration, facilitating lymphographic procedures and intraoperative identification of lymphatic anatomy.
The mechanism of action involves injection near the tumor periphery, wherein the dye localizes to the lymphatic system. This localization enables the surgeon to visually identify sentinel lymph nodes during oncology procedures, as these nodes absorb the blue dye and appear distinctly stained. This facilitates accurate excision or biopsy of sentinel lymph nodes, crucial in cancer staging and treatment planning.
Regarding absorption, distribution, metabolism, and excretion (ADME), isosulfan blue is mainly renally excreted following systemic absorption. Data on metabolic pathways are limited, but the compound’s elimination through renal routes necessitates consideration of renal function during use.
Safety profiles indicate that isosulfan blue is generally well tolerated. However, hypersensitivity reactions, including anaphylaxis, have been reported, necessitating appropriate preparedness during administration. Local injection site reactions and discoloration may occur. Users should be cautious in patients with known allergies to aniline dyes or related compounds.
Isosulfan blue products have been marketed under various brand names, including Lymphazurin. Its use is well-established in lymphatic mapping and sentinel node biopsy procedures in multiple regulatory jurisdictions.
From a sourcing perspective, procurement of isosulfan blue API should ensure compliance with pharmaceutical-grade purity standards. Stability, batch-to-batch consistency, and absence of contaminants, particularly azo impurities or heavy metals, are critical quality attributes. Suppliers with relevant regulatory certifications and validated manufacturing processes should be prioritized to maintain safety and efficacy in clinical applications.
Identification & chemistry
| Generic name | Isosulfan blue |
|---|---|
| Molecule type | Small molecule |
| CAS | 748080-29-7 |
| UNII | NS6Q291771 |
| DrugBank ID | DB09136 |
Pharmacology
| Summary | Isosulfan Blue is a synthetic dye used as a visual lymphatic imaging agent to aid in the identification of sentinel lymph nodes. After subcutaneous injection near the target site, it binds to serum proteins and localizes within lymphatic vessels, staining them blue for surgical visualization. Its primary application is to delineate lymphatic drainage in conditions such as lymphedema, chylous effusions, and lymph node assessment in neoplastic diseases. |
|---|---|
| Mechanism of action | Isosulfan Blue is injected into the periphery of the tumor site, it localizes to the lymphatic system and aids in the surgical identification of tumor sentinel nodes which stain blue. |
| Pharmacodynamics | Following subcutaneous administration, Lymphazurin 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye. |
ADME / PK
| Absorption | Intradermal and parenchymal injections of vital blue dyes, such as isosulfan blue, can lead to systemic absorption through lymphatic channels and vascular beds near tumor sites. |
|---|---|
| Half-life | Slow release of the dye from the subcutaneous tissue or the lymphatic tissue and the half-life of the dye in the body of several hours. |
| Protein binding | 1% binds to serum proteins |
| Route of elimination | Excreted unchanged in the urine |
| Volume of distribution | Not available |
| Clearance | Up to 10% of the subcutaneously administered dose of isosulfan blue 1% is excreted in 24 hours in human. |
Formulation & handling
- Isosulfan blue is a small molecule API intended for subcutaneous injectable formulations.
- Low aqueous solubility necessitates formulation strategies to ensure adequate dissolution and stability in solution.
- Handling should consider protection from light and moisture to maintain potency in solid and solution states.
Regulatory status
| Lifecycle | The API is approaching patent expiry in the US and Canada, leading to increased availability of generic formulations. As a result, the product is transitioning into a mature market phase characterized by greater competition and stabilized demand. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Isosulfan blue is primarily marketed in the US and Canadian markets with multiple branded products. The presence of several originator formulations indicates a competitive branded landscape. Given the data, there is no explicit information on patent status, but the availability of multiple brands suggests existing or potential generic competition. |
|---|
Safety
| Toxicity | LD50 greater than 150 mg/kg in the rat. |
|---|
- Handle with appropriate personal protective equipment to minimize dermal and ocular exposure
- Avoid inhalation of dust or aerosols during processing
- Dispose of waste materials in accordance with local regulations to prevent environmental contamination
Isosulfan blue is a type of Diagnostic agents
Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.
Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.
Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.
Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.
Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.
Isosulfan blue API manufacturers & distributors
Compare qualified Isosulfan blue API suppliers worldwide. We currently have 4 companies offering Isosulfan blue API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Biophore India | Producer | India | India | CoA, USDMF | 46 products |
| ChemPacific | Producer | United States | China | CoA, WC | 10 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
When sending a request, specify which Isosulfan blue API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Isosulfan blue API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
