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Chemistry

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Also known as: 68238-36-8, Sulphan blue, Isosulfan blue [usan], Iso-sulfan blue, Patentblueviolet, Sulphan blue 2,5-disulfophenyl isomer
Molecular Formula
C27H31N2NaO6S2
Molecular Weight
566.7  g/mol
InChI Key
NLUFDZBOHMOBOE-UHFFFAOYSA-M
FDA UNII
39N9K8S2A4

Isosulfan Blue
Isosulfan Blue is a synthetic visual lymphatic imaging agent. Injected into the periphery of the tumor site, isosulfan blue localizes to the lymphatic system and aids in the surgical identification of tumor sentinel nodes which stain blue. (NCI04)
1 2D Structure

Isosulfan Blue

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-[[4-(diethylamino)phenyl]-(4-diethylazaniumylidenecyclohexa-2,5-dien-1-ylidene)methyl]benzene-1,4-disulfonate
2.1.2 InChI
InChI=1S/C27H32N2O6S2.Na/c1-5-28(6-2)22-13-9-20(10-14-22)27(21-11-15-23(16-12-21)29(7-3)8-4)25-19-24(36(30,31)32)17-18-26(25)37(33,34)35;/h9-19H,5-8H2,1-4H3,(H-,30,31,32,33,34,35);/q;+1/p-1
2.1.3 InChI Key
NLUFDZBOHMOBOE-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CCN(CC)C1=CC=C(C=C1)C(=C2C=CC(=[N+](CC)CC)C=C2)C3=C(C=CC(=C3)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+]
2.2 Other Identifiers
2.2.1 UNII
39N9K8S2A4
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-(alpha-(p-(diethylamino)phenyl)-(2,5-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethylammonium Hydroxide Inner Salt, Sodium Salt

2. Iso-sulfan Blue

3. Iso-sulphan Blue

4. Lymphazurin

5. Lymphazurin Blue

2.3.2 Depositor-Supplied Synonyms

1. 68238-36-8

2. Sulphan Blue

3. Isosulfan Blue [usan]

4. Iso-sulfan Blue

5. Patentblueviolet

6. Sulphan Blue 2,5-disulfophenyl Isomer

7. Lymphazurin

8. Sodium 2-((4-(diethylamino)phenyl)(4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene)methyl)benzene-1,4-disulfonate

9. P-1888

10. P-4125

11. 39n9k8s2a4

12. Mfcd00867653

13. Nsc-734902

14. Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-n-ethyl-, Hydroxide, Inner Salt, Sodium Salt

15. Sulfanblau

16. Isosulfan Blue (usan)

17. Disulphin Blau

18. Patent Blau V

19. Azul Isosulfano

20. Bleu Isosulfan

21. Blu Isosulfan

22. Unii-39n9k8s2a4

23. Hsdb 8071

24. Azul De Isosulfan

25. P 1888

26. P 4125

27. Lymphazurin (tn)

28. Dsstox_cid_31594

29. Dsstox_rid_97478

30. Dsstox_gsid_57805

31. (4-(alpha-(p-(diethylamino)phenyl)-2,5-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethylammonium Hydroxide, Inner Salt, Sodium Salt

32. Isosulfan Blue [vandf]

33. Schembl3324345

34. Chembl1200859

35. Dtxsid8057805

36. Isosulfan Blue [who-dd]

37. Tox21_113733

38. Isosulfan Blue [orange Book]

39. Akos015904521

40. Fd10698

41. Nsc 734902

42. Ncgc00253597-01

43. Sy238240

44. Cas-68238-36-8

45. D04634

46. Sulphan Blue 2,5-disulfophenyl Isomer [mi]

47. (4-(.alpha.-(p-(diethylamino)phenyl)-2,5-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethylammonium Hydroxide, Inner Salt, Sodium Salt

48. Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,5-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-n-ethyl-, Inner Salt, Sodium Salt

49. Sodium 2-((4-(diethylamino)phenyl)(4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene)methyl)benzene-1,4-disulphonate

50. Sodium;2-[[4-(diethylamino)phenyl]-(4-diethylazaniumylidenecyclohexa-2,5-dien-1-ylidene)methyl]benzene-1,4-disulfonate

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 566.7 g/mol
Molecular Formula C27H31N2NaO6S2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass566.15212334 g/mol
Monoisotopic Mass566.15212334 g/mol
Topological Polar Surface Area137 Ų
Heavy Atom Count38
Formal Charge0
Complexity1040
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameIsosulfan blue
PubMed HealthIsosulfan Blue (Injection)
Drug ClassesDiagnostic Agent, Lymphatic Visualization
Drug LabelThe chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is:ISOSULFAN BLUEIsosulfan...
Active IngredientIsosulfan blue
Dosage FormInjectable
RouteInjection
Strength1%
Market StatusPrescription
CompanyMylan Institutional

2 of 2  
Drug NameIsosulfan blue
PubMed HealthIsosulfan Blue (Injection)
Drug ClassesDiagnostic Agent, Lymphatic Visualization
Drug LabelThe chemical name of isosulfan blue injection 1% is N-[4- [[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Its structural formula is:ISOSULFAN BLUEIsosulfan...
Active IngredientIsosulfan blue
Dosage FormInjectable
RouteInjection
Strength1%
Market StatusPrescription
CompanyMylan Institutional

4.2 Therapeutic Uses

Isosulfan blue injection 1% upon subcutaneous administration, delineates 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; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


4.3 Drug Warning

Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1%. Trained personnel should be available to administer emergency care including resuscitation.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


Isosulfan blue injection 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by four hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


For more Drug Warnings (Complete) data for Isosulfan blue (10 total), please visit the HSDB record page.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Coloring Agents

Chemicals and substances that impart color including soluble dyes and insoluble pigments. They are used in INKS; PAINTS; and as INDICATORS AND REAGENTS. (See all compounds classified as Coloring Agents.)


5.2 Absorption, Distribution and Excretion

Following subcutaneous administration, isosulfan blue injection 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


It is not known whether this drug is excreted in human milk.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


Up to 10% of the subcutaneously administered dose of isosulfan blue injection 1% is excreted unchanged in the urine in 24 hours in humans.

US Natl Inst Health; DailyMed. Current Medication Information for ISOSULFAN BLUE injection, solution (August 2010). Available from, as of June 8, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1878964e-5220-48c8-a872-dcadbc451aff


API Reference Price

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26-Aug-2021
28-Jun-2022
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ABOUT THIS PAGE

Isosulfan Blue Manufacturers

A Isosulfan Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosulfan Blue, including repackagers and relabelers. The FDA regulates Isosulfan Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosulfan Blue API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Isosulfan Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Isosulfan Blue Suppliers

A Isosulfan Blue supplier is an individual or a company that provides Isosulfan Blue active pharmaceutical ingredient (API) or Isosulfan Blue finished formulations upon request. The Isosulfan Blue suppliers may include Isosulfan Blue API manufacturers, exporters, distributors and traders.

click here to find a list of Isosulfan Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Isosulfan Blue USDMF

A Isosulfan Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosulfan Blue active pharmaceutical ingredient (API) in detail. Different forms of Isosulfan Blue DMFs exist exist since differing nations have different regulations, such as Isosulfan Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Isosulfan Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Isosulfan Blue USDMF includes data on Isosulfan Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosulfan Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Isosulfan Blue suppliers with USDMF on PharmaCompass.

Isosulfan Blue WC

A Isosulfan Blue written confirmation (Isosulfan Blue WC) is an official document issued by a regulatory agency to a Isosulfan Blue manufacturer, verifying that the manufacturing facility of a Isosulfan Blue active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isosulfan Blue APIs or Isosulfan Blue finished pharmaceutical products to another nation, regulatory agencies frequently require a Isosulfan Blue WC (written confirmation) as part of the regulatory process.

click here to find a list of Isosulfan Blue suppliers with Written Confirmation (WC) on PharmaCompass.

Isosulfan Blue NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Isosulfan Blue as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Isosulfan Blue API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Isosulfan Blue as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Isosulfan Blue and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isosulfan Blue NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Isosulfan Blue suppliers with NDC on PharmaCompass.

Isosulfan Blue GMP

Isosulfan Blue Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Isosulfan Blue GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Isosulfan Blue GMP manufacturer or Isosulfan Blue GMP API supplier for your needs.

Isosulfan Blue CoA

A Isosulfan Blue CoA (Certificate of Analysis) is a formal document that attests to Isosulfan Blue's compliance with Isosulfan Blue specifications and serves as a tool for batch-level quality control.

Isosulfan Blue CoA mostly includes findings from lab analyses of a specific batch. For each Isosulfan Blue CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Isosulfan Blue may be tested according to a variety of international standards, such as European Pharmacopoeia (Isosulfan Blue EP), Isosulfan Blue JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isosulfan Blue USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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