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Chemistry

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Also known as: Iothalamic acid, 2276-90-6, 3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic acid, 5-acetamido-2,4,6-triiodo-n-methylisophthalamic acid, Iotalamic acid [inn], Mi-216
Molecular Formula
C11H9I3N2O4
Molecular Weight
613.91  g/mol
InChI Key
UXIGWFXRQKWHHA-UHFFFAOYSA-N
FDA UNII
16CHD79MIX

Iotalamic Acid
A contrast medium in diagnostic radiology with properties similar to those of diatrizoic acid. It is used primarily as its sodium and meglumine (IOTHALAMATE MEGLUMINE) salts.
Iothalamic acid is a Radiographic Contrast Agent. The mechanism of action of iothalamic acid is as a X-Ray Contrast Activity.
1 2D Structure

Iotalamic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic acid
2.1.2 InChI
InChI=1S/C11H9I3N2O4/c1-3(17)16-9-7(13)4(10(18)15-2)6(12)5(8(9)14)11(19)20/h1-2H3,(H,15,18)(H,16,17)(H,19,20)
2.1.3 InChI Key
UXIGWFXRQKWHHA-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)C(=O)NC)I
2.2 Other Identifiers
2.2.1 UNII
16CHD79MIX
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acid, Iotalamic

2. Acid, Iothalamic

3. Acid, Methalamic

4. Angio Conray

5. Angio-conray

6. Angioconray

7. Conray 420

8. Iodothalamate

9. Iothalamate

10. Iothalamate, Sodium

11. Iothalamic Acid

12. Iothalamic Acid, Calcium (2:1) Salt

13. Iothalamic Acid, Monosilver (1+) Salt

14. Iothalamic Acid, Monosodium Salt

15. Iothalamic Acid, Monosodium Salt, Dimer

16. Lopamidol

17. Methalamic Acid

18. Sodium Iothalamate

2.3.2 Depositor-Supplied Synonyms

1. Iothalamic Acid

2. 2276-90-6

3. 3-acetamido-2,4,6-triiodo-5-(methylcarbamoyl)benzoic Acid

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

5. Iotalamic Acid [inn]

6. Mi-216

7. Nsc-759891

8. 16chd79mix

9. 3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]benzoic Acid

10. Acidum Jotalamicum

11. Acido Iotalamico

12. Iothalamic Acid [usan]

13. Acide Iotalamique

14. Acidum Iotalamicum

15. Acide Iotalamique [inn-french]

16. Acido Iotalamico [inn-spanish]

17. Acidum Iotalamicum [inn-latin]

18. Einecs 218-897-4

19. Mi 216

20. Unii-16chd79mix

21. Iothalamic Acid [usan:usp]

22. Iothalamic-acid-d3

23. Benzoic Acid, 3-(acetylamino)-2,4,6-triiodo-5-((methylamino)carbonyl)-

24. Iothalamic Acid (usp)

25. Ec 218-897-4

26. Iothalamate [vandf]

27. Schembl38419

28. Iotalamic Acid [jan]

29. Iothalamic Acid [mi]

30. Iotalamic Acid (jp17/inn)

31. Iothalamicacid(200mg)

32. Iotalamic Acid [mart.]

33. Chembl1201300

34. Dtxsid5023164

35. Iotalamic Acid [who-dd]

36. Schembl23630220

37. Chebi:31713

38. Iothalamic Acid [usp-rs]

39. Hms3264d13

40. Pharmakon1600-01503836

41. Bcp13316

42. Hy-b1053

43. Zinc3830961

44. Iotalamic Acid [ep Impurity]

45. Nsc759891

46. Akos025402283

47. Benzoic Acid,3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]-

48. Ac-7611

49. Ccg-213208

50. Cs-4575

51. Db09133

52. Iothalamic Acid [usp Monograph]

53. Nsc 759891

54. Ncgc00183042-01

55. Ft-0740526

56. D01258

57. Ab01563288_01

58. 276i906

59. Sr-01000944232

60. Q-201246

61. Q6064129

62. Sr-01000944232-1

63. 5-acetylamino-2,4,6-triiodo-n-methyl-isophthalamic Acid

64. 1-deoxy-1-(methylamino)-d-glucitol 5-acetamido-2,4,6 Triiodo-n-methylisophthalamate

65. Benzoic Acid, 3-(acetylamino)-2,4,6-triiodo-5-((methylamino)carbonyl

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 613.91 g/mol
Molecular Formula C11H9I3N2O4
XLogP31.9
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass613.7696 g/mol
Monoisotopic Mass613.7696 g/mol
Topological Polar Surface Area95.5 Ų
Heavy Atom Count20
Formal Charge0
Complexity421
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space.


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 Active Moiety
IOTHALAMIC ACID
5.2.2 FDA UNII
16CHD79MIX
5.2.3 Pharmacological Classes
Mechanisms of Action [MoA] - X-Ray Contrast Activity
5.3 ATC Code

V - Various

V08 - Contrast media

V08A - X-ray contrast media, iodinated

V08AA - Watersoluble, nephrotropic, high osmolar x-ray contrast media

V08AA04 - Iotalamic acid


5.4 Absorption, Distribution and Excretion

Absorption

Renal accumulation is sufficiently rapid that maximum radiographic density in the calyces and pelves occurs, in most instances, about 3 to 8 minutes after injection. In patients with impaired renal function, diagnostic opacification frequently is achieved only after prolonged periods.


Route of Elimination

Following intravascular injection, Conray is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine by glomerular filtration. The liver and small intestine provide the major alternate route of excretion. In patients with severe renal impairment, the excretion of this contrast medium through the gallbladder and into the small intestine sharply increases.


5.5 Biological Half-Life

In patients with normal renal function, the alpha and beta half-lives of Conray were approximately 10 and 90 minutes, respectively.


API SUPPLIERS

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Grupo Juste

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Grupo Juste

Spain

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Mallinckrodt Pharmaceuticals

Ireland

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Mallinckrodt Pharmaceuticals

Ireland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Mallinckrodt Pharmaceuticals

Ireland

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Mallinckrodt Pharmaceuticals

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Bracco

Italy

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Bracco

Italy

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USDMF

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PharmaVenue
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PharmaVenue
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6206

Submission : 1986-02-21

Status : Inactive

Type : II

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Justesa Imagen Sau

Spain

USDMF

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Specgx Llc

Ireland

USDMF

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Specgx Llc

Ireland
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2479

Submission : 1975-06-20

Status : Active

Type : II

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Mallinckrodt Inc

Ireland

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4749

Submission : 1982-11-11

Status : Inactive

Type : II

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INTERMEDIATES SUPPLIERS

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CAS Number : CAS-1955-46-0

End Use API : Iotalamic Acid

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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CAS Number : CAS-1954-97-8

End Use API : Iotalamic Acid

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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CAS Number : CAS-1954-97-8

End Use API : Iotalamic Acid

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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FDF Dossiers

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Regulatory Info :

Registration Country : India

Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 200MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Regulatory Info :

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Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 300MG/ML

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Regulatory Info :

Registration Country : India

Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 370MG/ML

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore
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Listed Dossiers

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 200MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Iotalamic Acid

Dosage : Injection

Dosage Strength : 200MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 300MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Iotalamic Acid

Dosage : Injection

Dosage Strength : 300MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Biophore

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Iotalamic Acid

Brand Name :

Dosage Form : Injection

Dosage Strength : 370MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Biophore

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Iotalamic Acid

Dosage : Injection

Dosage Strength : 370MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Biophore
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ABOUT THIS PAGE

Iotalamic Acid Manufacturers

A Iotalamic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iotalamic Acid, including repackagers and relabelers. The FDA regulates Iotalamic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iotalamic Acid 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 Iotalamic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Iotalamic Acid Suppliers

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

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

Iotalamic Acid USDMF

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

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

click here to find a list of Iotalamic Acid suppliers with USDMF on PharmaCompass.

Iotalamic Acid 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 Iotalamic Acid as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Iotalamic Acid 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 Iotalamic Acid 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 Iotalamic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iotalamic Acid NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Iotalamic Acid suppliers with NDC on PharmaCompass.

Iotalamic Acid GMP

Iotalamic Acid 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 Iotalamic Acid 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 Iotalamic Acid GMP manufacturer or Iotalamic Acid GMP API supplier for your needs.

Iotalamic Acid CoA

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

Iotalamic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Iotalamic Acid 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.

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