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Indocyanine green acid form | CAS No: 28782-33-4 | GMP-certified suppliers
A medication that supports cardiac output assessment, evaluates hepatic function and liver blood flow, and provides reliable visualization for ophthalmic angiography in diagnostic applications.
Therapeutic categories
BSEP/ABCB11 SubstratesCardiac FunctionColoring AgentsCompounds used in a research, industrial, or household settingDiagnostic DyeHeterocyclic Compounds, Fused-Ring
Generic name
Indocyanine green acid form
Molecule type
small molecule
CAS number
28782-33-4
DrugBank ID
DB09374
Approval status
Approved drug, Investigational drug
Primary indications
- For Determining Cardiac Output, Hepatic Function and Liver Blood Flow
- For ophthalmic angiography
Product Snapshot
- This product is a small‑molecule diagnostic dye supplied as lyophilized powder for reconstitution for intravascular and related injectable use
- It is used for assessing cardiac output, hepatic function, liver blood flow, and for ophthalmic angiography
- It holds approved and investigational status in the US and Canada
Clinical Overview
Indocyanine green acid form (CAS 28782-33-4) is a water‑soluble tricarbocyanine dye used as a diagnostic agent for assessing cardiac output, hepatic function, liver blood flow, and for ophthalmic angiography. Its strong absorption peak near 800 nm enables use with near‑infrared imaging systems and hemodynamic monitoring techniques. The material is typically supplied as a sterile lyophilized powder containing 25 mg of dye with limited sodium iodide content.
Following intravenous administration, the compound remains largely confined to the intravascular space and exhibits minimal extrahepatic distribution. Uptake occurs almost exclusively via hepatic parenchymal cells, and the dye is subsequently excreted unchanged into bile. It does not undergo significant enterohepatic recirculation, and negligible renal or peripheral tissue accumulation has been observed. These elimination characteristics support its utility in dynamic liver function assessment, including plasma disappearance rate measurements.
The mechanism of action is based on hepatic extraction efficiency and biliary excretion. In cases of biliary obstruction, the compound may appear in hepatic lymph rather than bile, a feature illustrating preserved mucosal integrity despite impaired ductal flow. In ophthalmology, the dye enables visualization of choroidal vasculature due to its protein binding and near‑infrared optical properties, which enhance imaging through pigment and exudate.
Key ADME features include rapid plasma clearance through hepatobiliary pathways, high protein binding, and a short circulation half‑life conducive to repeated measurements within clinical procedures. Systemic pharmacodynamic activity is minimal, as the compound serves primarily as an optical tracer.
Safety considerations focus on rare hypersensitivity reactions and iodine‑related sensitivities due to trace sodium iodide residues. Caution is warranted in severe hepatic dysfunction, where clearance is reduced and interpretation of diagnostic parameters may be altered.
For API procurement, sourcing should prioritize sterile production capability, tight control of iodide content, and robust spectral purity testing to ensure consistent near‑infrared performance and suitability for parenteral formulation.
Following intravenous administration, the compound remains largely confined to the intravascular space and exhibits minimal extrahepatic distribution. Uptake occurs almost exclusively via hepatic parenchymal cells, and the dye is subsequently excreted unchanged into bile. It does not undergo significant enterohepatic recirculation, and negligible renal or peripheral tissue accumulation has been observed. These elimination characteristics support its utility in dynamic liver function assessment, including plasma disappearance rate measurements.
The mechanism of action is based on hepatic extraction efficiency and biliary excretion. In cases of biliary obstruction, the compound may appear in hepatic lymph rather than bile, a feature illustrating preserved mucosal integrity despite impaired ductal flow. In ophthalmology, the dye enables visualization of choroidal vasculature due to its protein binding and near‑infrared optical properties, which enhance imaging through pigment and exudate.
Key ADME features include rapid plasma clearance through hepatobiliary pathways, high protein binding, and a short circulation half‑life conducive to repeated measurements within clinical procedures. Systemic pharmacodynamic activity is minimal, as the compound serves primarily as an optical tracer.
Safety considerations focus on rare hypersensitivity reactions and iodine‑related sensitivities due to trace sodium iodide residues. Caution is warranted in severe hepatic dysfunction, where clearance is reduced and interpretation of diagnostic parameters may be altered.
For API procurement, sourcing should prioritize sterile production capability, tight control of iodide content, and robust spectral purity testing to ensure consistent near‑infrared performance and suitability for parenteral formulation.
Identification & chemistry
| Generic name | Indocyanine green acid form |
|---|---|
| Molecule type | Small molecule |
| CAS | 28782-33-4 |
| UNII | C4V974V932 |
| DrugBank ID | DB09374 |
Pharmacology
| Summary | Indocyanine green is a diagnostic dye that binds plasma proteins and is cleared almost exclusively by hepatic parenchymal cells, with secretion directly into bile and minimal extrahepatic distribution. Its pharmacokinetic profile allows assessment of hepatic uptake and excretion, as well as indicator-dilution measurements of cardiac output and liver blood flow. The compound also provides vascular contrast for ophthalmic angiography. |
|---|---|
| Mechanism of action | Indocyanine Green for Injection USP undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green for Injection USP is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green for Injection USP a helpful index of hepatic function. |
ADME / PK
| Absorption | It has a peak spectral absorption at about 800 nm. |
|---|---|
| Half-life | ICG has a half-life of 150 to 180 seconds. |
| Protein binding | 98% |
| Route of elimination | The dye is excreted in bile in unconjugated form. |
| Volume of distribution | ICG distribution into the mouse fetus can be enhanced when used concomitantly with OATP or P-glycoprotein inhibitors. The greater distribution within individual fetal tissues is likely related to ICG's greater transplacental transfer. |
| Clearance | Clearance of dyes which are removed from the circulation principally by the liver constitutes one of the best methods for evaluating hepatic function. |
Formulation & handling
- Indocyanine green is supplied as a lyophilized powder for aqueous reconstitution and parenteral administration, with light sensitivity requiring protection during preparation and handling.
- The hydrophobic small‑molecule structure (high LogP) necessitates formulation with solubilizing excipients to ensure complete dissolution for intravenous use.
- Solutions should be used promptly after reconstitution due to limited stability in aqueous media and susceptibility to degradation under ambient conditions.
Regulatory status
| Lifecycle | Most U.S. patent protection for the API has expired, with remaining coverage extending into 2025 and then through 2028–2029, indicating a transition toward later‑stage market maturity. With products marketed in the US and Canada, the API is moving toward increased post‑exclusivity availability as remaining patents lapse. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Indocyanine green acid form appears to have a single originator lineage supplying branded products primarily to the US and Canadian markets, with no clear evidence of broader global brand distribution. Multiple US patents have already expired, while a few remain active through 2025–2029. This pattern indicates that some generic competition may already be possible in the US, with additional entry likely as the remaining patents expire. |
|---|
Safety
| Toxicity | Mouse LD50 60mg/kg ( intravenous ) Rat LD50 : 87mh/kg ( intravenous) |
|---|
High Level Warnings:
- Exhibits relatively high acute toxicity in rodents (intravenous LD50 ≈60 mg/kg in mice and ≈87 mg/kg in rats), indicating need for controlled handling and minimized exposure
- Potential for systemic toxicity requires use in closed or well‑ventilated systems with appropriate containment to prevent accidental injection or aerosolization
- Processing should incorporate measures to avoid ocular or dermal contact due to its use in vascular and ophthalmic imaging contexts and potential for tissue irritation
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Indocyanine green 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.
Indocyanine green API manufacturers & distributors
Compare qualified Indocyanine green API suppliers worldwide. We currently have 2 companies offering Indocyanine green 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, ISO9001, MSDS | 250 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
When sending a request, specify which Indocyanine green 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 Indocyanine green 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.
Frequently asked questions about Indocyanine green API
Sourcing
What matters most when sourcing GMP-grade Indocyanine green acid form?
Key considerations include confirming GMP compliance that meets US and Canadian regulatory expectations and verifying the material’s origin given the single known originator lineage. Assessing patent status is important because some US patents have expired while others remain active through 2025–2029, which may affect procurement options. It is also essential to confirm supply reliability within the limited regional distribution pattern.
Which documents are typically required when sourcing Indocyanine green acid form API?
Request the core API documentation set: CoA (2 companies), MSDS (2 companies), BSE/TSE (2 companies), ISO9001 (2 companies), CEP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Indocyanine green acid form API?
Known or reported manufacturers for Indocyanine green acid form: Aurora Industry Co., Ltd, Global Pharma Tek. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Indocyanine green acid form API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Indocyanine green acid form manufacturers?
Audit reports may be requested for Indocyanine green acid form: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Indocyanine green acid form API on Pharmaoffer?
Reported supplier count for Indocyanine green acid form: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Indocyanine green acid form API?
Production countries reported for Indocyanine green acid form: China (1 producer), India (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Indocyanine green acid form usually hold?
Common certifications for Indocyanine green acid form suppliers: CoA (2 companies), MSDS (2 companies), BSE/TSE (2 companies), ISO9001 (2 companies), CEP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Indocyanine green acid form (CAS 28782-33-4) used for?
Indocyanine green acid form is used as a near‑infrared diagnostic dye for measuring cardiac output, assessing hepatic function, and evaluating liver blood flow. It is also used in ophthalmic angiography to visualize the choroidal vasculature. Its utility is based on exclusive hepatic uptake, biliary excretion, and strong absorption near 800 nm for imaging applications.
Which therapeutic class does Indocyanine green acid form fall into?
Indocyanine green acid form belongs to the following therapeutic categories: BSEP/ABCB11 Substrates, Cardiac Function, Coloring Agents, Compounds used in a research, industrial, or household setting, Diagnostic Dye. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Indocyanine green acid form mainly prescribed for?
The primary indications for Indocyanine green acid form: For Determining Cardiac Output, Hepatic Function and Liver Blood Flow, For ophthalmic angiography. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Indocyanine green acid form work?
Indocyanine green for Injection USP undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine green for Injection USP is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine green for Injection USP a helpful index of hepatic function.
What should someone know about the safety or toxicity profile of Indocyanine green acid form?
Indocyanine green acid form shows relatively high acute toxicity in rodents, so handling should minimize exposure and avoid accidental injection or aerosolization. It can cause tissue irritation, making eye and skin protection necessary during processing. Rare hypersensitivity reactions and iodine‑related sensitivities may occur due to trace sodium iodide. Reduced clearance in severe hepatic dysfunction warrants caution because systemic levels may increase.
What are important formulation and handling considerations for Indocyanine green acid form as an API?
Important considerations include reconstituting the lyophilized powder with an appropriate aqueous vehicle and protecting the material from light during preparation and handling due to its light sensitivity. Its hydrophobic character and high LogP require use of suitable solubilizing excipients to achieve complete dissolution for intravenous administration. Reconstituted solutions should be used promptly because of limited aqueous stability and susceptibility to degradation under ambient conditions.
Is Indocyanine green acid form a small molecule?
Indocyanine green acid form is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Indocyanine green acid form?
Indocyanine green is light‑sensitive and should be protected from illumination during preparation and handling. Once dissolved, it has limited stability in aqueous media and can degrade under ambient conditions, so solutions should be used promptly. Its hydrophobic structure also requires appropriate solubilizing conditions to maintain complete dissolution.
Regulatory
Where is Indocyanine green acid form approved or in use globally?
Indocyanine green acid form is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Indocyanine green acid form right now?
In the United States and Canada, Indocyanine green is an established diagnostic active ingredient with long‑standing regulatory acceptance. Its original patents have expired, and the acid form is generally regarded as off‑patent, with no active exclusivities reported. Regulatory oversight focuses on compliance with quality and compendial standards for diagnostic dyes.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Indocyanine green acid form procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Indocyanine green acid form. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Indocyanine green acid form included in the PRO Data Insights coverage?
PRO Data Insights coverage for Indocyanine green acid form: 27 verified transactions across 13 suppliers and 7 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Indocyanine green acid form?
Market report availability for Indocyanine green acid form: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
