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Also known as: 13087-53-1, Meglumine iotalamate, Conray, Meglumine iothalamate, Iotalamate meglumine, Xuw72gop7w
Molecular Formula
C18H26I3N3O9
Molecular Weight
809.1  g/mol
InChI Key
VLHUSFYMPUDOEL-WZTVWXICSA-N
FDA UNII
XUW72GOP7W

Iothalamate Meglumine
A radiopaque medium used for urography, angiography, venography, and myelography. It is highly viscous and binds to plasma proteins.
1 2D Structure

Iothalamate Meglumine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
2.1.2 InChI
InChI=1S/C11H9I3N2O4.C7H17NO5/c1-3(17)16-9-7(13)4(10(18)15-2)6(12)5(8(9)14)11(19)20;1-8-2-4(10)6(12)7(13)5(11)3-9/h1-2H3,(H,15,18)(H,16,17)(H,19,20);4-13H,2-3H2,1H3/t;4-,5+,6+,7+/m.0/s1
2.1.3 InChI Key
VLHUSFYMPUDOEL-WZTVWXICSA-N
2.1.4 Canonical SMILES
CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)C(=O)NC)I.CNCC(C(C(C(CO)O)O)O)O
2.1.5 Isomeric SMILES
CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)C(=O)NC)I.CNC[C@@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O
2.2 Other Identifiers
2.2.1 UNII
XUW72GOP7W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Conray 60

2. Iotalamate Meglumine

3. Iotalamate, Meglumine

4. Iotalamate, Methylglucamine

5. Iothalamate, Meglumine

6. Iothalamate, Methylglucamine

7. Iothalamic Acid Meglumine

8. Iothalamic Acid Methylglucamine

9. Meglumine Iotalamate

10. Meglumine Iothalamate

11. Meglumine, Iotalamate

12. Meglumine, Iothalamate

13. Meglumine, Iothalamic Acid

14. Methylglucamine Iotalamate

15. Methylglucamine Iothalamate

16. Methylglucamine, Iothalamic Acid

2.3.2 Depositor-Supplied Synonyms

1. 13087-53-1

2. Meglumine Iotalamate

3. Conray

4. Meglumine Iothalamate

5. Iotalamate Meglumine

6. Xuw72gop7w

7. Iothalamate Meglumine [usp]

8. Meglumine Iotalamate Injection

9. 1-deoxy-1-(methylamino)-d-glucitol 3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]benzoate

10. 3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic Acid;(2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentol

11. 1-deoxy-1-(methylamino)-d-glucitol 5-acetamido-2,4,6-triiodo-n-methylisophthalamate (salt)

12. Iothalamate Meglumine (usp)

13. Conray 60

14. Conray Meglumin

15. Meglumine Conray

16. Methylglucamine Iotalamate

17. Cysto-conray

18. Methylglucamine Iothalamate

19. Cysto-conray Ii

20. 3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic Acid;6-(methylamino)hexane-1,2,3,4,5-pentol

21. Benzoic Acid, 3-(acetylamino)-2,4,6-triiodo-5-((methylamino)carbonyl)-, Compd. With 1-deoxy-1-(methylamino)-d-glucitol (1:1)

22. Contrix 28

23. Conray 30

24. Conray 43

25. Meglumine Isothalamate

26. Conray Meglumine 282

27. Iothalamate Methylglucamine

28. Iotalamate De Methylglucamine

29. Iothalamate Methylglucamine Salt

30. Jotalamsaeure Methylglucaminesalz

31. 1-deoxy-1-(methylamino)-d-glucitol 3-(acetylamino)-2,4,6-triiodo-5-((methylamino)carbonyl)benzoate

32. Einecs 235-998-9

33. Conray (tn)

34. Iothalamic Acid N-methylgucamine Salt

35. Iotalamate De Methylglucamine [french]

36. Iotalamic Acid Meglumine

37. Jotalamsaeure Methylglucaminesalz [german]

38. Unii-xuw72gop7w

39. Meglumine Iothalamate [ban]

40. D-glucitol, 1-deoxy-1-(methylamino)-, 3-(acetylamino)-2,4,6-triiodo-5-((methylamino)carbonyl)benzoate (salt)

41. Meglumine Iotalamate (jp17)

42. Schembl180546

43. Chembl1201125

44. Chebi:31714

45. Dtxsid10926949

46. Iothalamate Meglumine [vandf]

47. Meglumine Iotalamate [mart.]

48. Iotalamate Meglumine [who-dd]

49. Isophthalamic Acid, 5-acetamido-2,4,6-triiodo-n-methyl-, Compd. With 1-deoxy-1-(methylamino)-d-glucitol (1:1)

50. Iothalamate Meglumine [orange Book]

51. Iothalamate Meglumine [usp Impurity]

52. D01999

53. Vascoray Component Iothalamate Meglumine

54. Iothalamate Meglumine Component Of Vascoray

55. Iothalamic Acid N-methylglucamine Salt [mi]

56. Q27294007

57. 5-acetamido-2,4,6-triiodo-n-methylisophthalamic Acid-methylglucamine

58. Benzoic Acid, 3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]-, Compd. With D-glucitol, 1-deoxy-1-(methylamino)- (1:1)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 809.1 g/mol
Molecular Formula C18H26I3N3O9
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count10
Rotatable Bond Count9
Exact Mass808.8803 g/mol
Monoisotopic Mass808.8803 g/mol
Topological Polar Surface Area209 Ų
Heavy Atom Count33
Formal Charge0
Complexity555
Isotope Atom Count0
Defined Atom Stereocenter Count4
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 8  
Drug NameConray 30
Drug LabelConray 30 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 30 contains 30% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6 triiodo-N-methylisophthalamate (salt), and has...
Active IngredientIothalamate meglumine
Dosage FormInjectable
RouteInjection
Strength30%
Market StatusPrescription
CompanyMallinckrodt

2 of 8  
Drug NameConray 43
Drug LabelConray 43 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 43 contains 43% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt), and has...
Active IngredientIothalamate meglumine
Dosage FormInjectable
RouteInjection
Strength43%
Market StatusPrescription
CompanyMallinckrodt

3 of 8  
Drug NameCysto-conray
Drug LabelCysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophtha...
Active IngredientIothalamate meglumine
Dosage FormSolution
Routeintravesical, ureteral
Strength43%
Market StatusPrescription
CompanyMallinckrodt

4 of 8  
Drug NameCysto-conray ii
Drug LabelCysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophtha...
Active IngredientIothalamate meglumine
Dosage FormSolution
RouteIntravesical
Strength17.2%
Market StatusPrescription
CompanyMallinckrodt

5 of 8  
Drug NameConray 30
Drug LabelConray 30 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 30 contains 30% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6 triiodo-N-methylisophthalamate (salt), and has...
Active IngredientIothalamate meglumine
Dosage FormInjectable
RouteInjection
Strength30%
Market StatusPrescription
CompanyMallinckrodt

6 of 8  
Drug NameConray 43
Drug LabelConray 43 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 43 contains 43% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt), and has...
Active IngredientIothalamate meglumine
Dosage FormInjectable
RouteInjection
Strength43%
Market StatusPrescription
CompanyMallinckrodt

7 of 8  
Drug NameCysto-conray
Drug LabelCysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophtha...
Active IngredientIothalamate meglumine
Dosage FormSolution
Routeintravesical, ureteral
Strength43%
Market StatusPrescription
CompanyMallinckrodt

8 of 8  
Drug NameCysto-conray ii
Drug LabelCysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophtha...
Active IngredientIothalamate meglumine
Dosage FormSolution
RouteIntravesical
Strength17.2%
Market StatusPrescription
CompanyMallinckrodt

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Contrast Media

Substances used to allow enhanced visualization of tissues. (See all compounds classified as Contrast Media.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
X-Ray Contrast Activity [MoA]; Radiographic Contrast Agent [EPC]

DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 43%

USFDA APPLICATION NUMBER - 13295

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DOSAGE - INJECTABLE;INJECTION - 60%

USFDA APPLICATION NUMBER - 13295

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DOSAGE - INJECTABLE;INJECTION - 30%

USFDA APPLICATION NUMBER - 16983

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FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

Impressions: 3633

https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

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11 Jul 2024

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Looking for 13087-53-1 / Iothalamate Meglumine API manufacturers, exporters & distributors?

Iothalamate Meglumine manufacturers, exporters & distributors 1

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PharmaCompass also assists you with knowing the Iothalamate Meglumine API Price utilized in the formulation of products. Iothalamate Meglumine API Price is not always fixed or binding as the Iothalamate Meglumine Price is obtained through a variety of data sources. The Iothalamate Meglumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Iothalamate Meglumine

Synonyms

13087-53-1, Meglumine iotalamate, Conray, Meglumine iothalamate, Iotalamate meglumine, Xuw72gop7w

Cas Number

13087-53-1

Unique Ingredient Identifier (UNII)

XUW72GOP7W

About Iothalamate Meglumine

A radiopaque medium used for urography, angiography, venography, and myelography. It is highly viscous and binds to plasma proteins.

Iothalamate Meglumine Manufacturers

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

Iothalamate Meglumine Suppliers

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

Iothalamate Meglumine GMP

Iothalamate Meglumine 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 Iothalamate Meglumine 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 Iothalamate Meglumine GMP manufacturer or Iothalamate Meglumine GMP API supplier for your needs.

Iothalamate Meglumine CoA

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

Iothalamate Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Iothalamate Meglumine 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.

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