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1. 3,3'-((2,2,-dimethyl-1,3-propanediyl)diimino)bis-2-butanone Dioxime, (r*,r*-(e,e))-
1. 105613-48-7
2. Dl Hm-pao
3. G29272nckl
4. Hexametazime
5. Exametazima
6. Exametazimum
7. Hmpao
8. Dl-hm-pao
9. Dl-hmpao
10. Exametazimum [latin]
11. Exametazima [spanish]
12. Unii-g29272nckl
13. Technetium Tc99m Exametazime
14. Hexamethylpropylene Amine Oxide
15. Exametazime [usan:inn:ban:jan]
16. Meso-rich Exametazime
17. Exametazime [ii]
18. Exametazime [mi]
19. Exametazime [inn]
20. Exametazime [jan]
21. Exametazime [usan]
22. Dsstox_cid_31403
23. Dsstox_rid_97289
24. D,1-hexamethylpropylene Amine Oxime-(sup 99m)tc
25. Dsstox_gsid_57614
26. Exametazime [who-dd]
27. Schembl137569
28. Exametazime (jan/usan/inn)
29. Chembl1615781
30. Dtxsid1057614
31. Chebi:31586
32. Ex-a4790
33. Tox21_113984
34. (+-)-(3rs,3'rs)-3,3'-((2,2-dimethyltrimethylene)diimino)di-2-butanone (e,e)-dioxime
35. Dl-hexamethylpropylene Amine Oxide
36. Ncgc00319018-01
37. Ac-29748
38. Cas-105613-48-7
39. D01109
40. 2-butanone, 3,3'-((2,2-dimethyl-1,3-propanediyl)diimino)bis-dioxime-(sup 99m)tc
41. (+/-)-(3rs,3'rs)-3,3'-((2,2-dimethyltrimethylene)diimino)di-2-butanone (e,e)-dioxime
42. (ne)-n-[(3r)-3-[[3-[[(2r,3e)-3-hydroxyiminobutan-2-yl]amino]-2,2-dimethylpropyl]amino]butan-2-ylidene]hydroxylamine
43. 2-butanone, 3,3'-((2,2-dimethyl-1,3-propanediyl)diimino)bis-, Dioxime, (r*,r*-(e,e))-(+-)-
44. 2-butanone, 3,3'-((2,2-dimethyl-1,3-propanediyl)diimino)bis-, Dioxime, (r*,r*-(e,e))-(+/-)-
| Molecular Weight | 272.39 g/mol |
|---|---|
| Molecular Formula | C13H28N4O2 |
| XLogP3 | 1.4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 8 |
| Exact Mass | 272.22122615 g/mol |
| Monoisotopic Mass | 272.22122615 g/mol |
| Topological Polar Surface Area | 89.2 Ų |
| Heavy Atom Count | 19 |
| Formal Charge | 0 |
| Complexity | 297 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26912
Submission : 2013-09-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35175
Submission : 2020-12-09
Status : Inactive
Type : II

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Regulatory Info :
Registration Country : USA
TECHNETIUM TC99M ALBUMIN AGGREGATED
Brand Name : PULMOTECH MAA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 210089
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : Italy
Brand Name : Ceretec
Dosage Form : Esametazima 0.5Mg 2 Units Parenteral Use
Dosage Strength : 2 VIALS EV 0.5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Brand Name : Ceretec
Dosage Form : Esametazima 0.5Mg 5 Units Parenteral Use
Dosage Strength : 5 VIALS EV 0.5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Ceretec - Kit For The Preparation Of Technetium [99Mtc] Exametazime
Dosage Form : Powder For Solution For Injection
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2007-08-01
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Stabilised Ceretec
Dosage Form : Kit For Radiopharmaceutical Preparation
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2013-09-05
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Cobalt chloride hexahydrate; Examethazime
Brand Name : Stabilized Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Cobalt chloride hexahydrate; Examethazime
Brand Name : Stabilized Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ceretec Estabilizado
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 500MCG
Packaging :
Approval Date : 01-07-1999
Application Number : 62666
Regulatory Info : Authorized
Registration Country : Spain

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RLD :
TE Code :
TECHNETIUM TC99M ALBUMIN AGGREGATED
Brand Name : PULMOTECH MAA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG
Approval Date :
Application Number : 210089
RX/OTC/DISCN :
RLD :
TE Code :

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Regulatory Info :
Registration Country : Italy
Brand Name : Ceretec
Dosage Form : Esametazima 0.5Mg 2 Units Parenteral Use
Dosage Strength : 2 VIALS EV 0.5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Ceretec - Kit For The Preparation Of Technetium [99Mtc] Exametazime
Dosage Form : Powder For Solution For Injection
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2007-08-01
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Stabilised Ceretec
Dosage Form : Kit For Radiopharmaceutical Preparation
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2013-09-05
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Cobalt chloride hexahydrate; Examethazime
Brand Name : Stabilized Ceretec
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ceretec Estabilizado
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 500MCG
Packaging :
Approval Date : 01-07-1999
Application Number : 62666
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ceretec
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 500MCG
Packaging :
Approval Date : 01-05-1997
Application Number : 61024
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Stabilized Ceretec
Dosage Form : Radiopharmaceutical
Dosage Strength :
Packaging :
Approval Date : 08-11-1999
Application Number : 28120202399
Regulatory Info : Prescription
Registration Country : Denmark

Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Exametazime Radiopharmacy
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 500MCG
Packaging :
Approval Date : 24-04-2013
Application Number : 77468
Regulatory Info : Authorized
Registration Country : Spain

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PharmaCompass offers a list of Exametazime API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Exametazime manufacturer or Exametazime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Exametazime manufacturer or Exametazime supplier.
A Exametazime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exametazime, including repackagers and relabelers. The FDA regulates Exametazime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exametazime API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Exametazime supplier is an individual or a company that provides Exametazime active pharmaceutical ingredient (API) or Exametazime finished formulations upon request. The Exametazime suppliers may include Exametazime API manufacturers, exporters, distributors and traders.
click here to find a list of Exametazime suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Exametazime DMF (Drug Master File) is a document detailing the whole manufacturing process of Exametazime active pharmaceutical ingredient (API) in detail. Different forms of Exametazime DMFs exist exist since differing nations have different regulations, such as Exametazime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exametazime DMF submitted to regulatory agencies in the US is known as a USDMF. Exametazime USDMF includes data on Exametazime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exametazime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exametazime suppliers with USDMF on PharmaCompass.
Exametazime 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 Exametazime GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Exametazime GMP manufacturer or Exametazime GMP API supplier for your needs.
A Exametazime CoA (Certificate of Analysis) is a formal document that attests to Exametazime's compliance with Exametazime specifications and serves as a tool for batch-level quality control.
Exametazime CoA mostly includes findings from lab analyses of a specific batch. For each Exametazime 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.
Exametazime may be tested according to a variety of international standards, such as European Pharmacopoeia (Exametazime EP), Exametazime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Exametazime USP).