Synopsis
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CEP/COS
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JDMF
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EU WC
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Listed Suppliers
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EDQM
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USP
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JP
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FDA Orange Book
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Australia
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1. Cardio-spect
2. 103694-84-4
3. Copper(1+);1-isocyano-2-methoxy-2-methylpropane;tetrafluoroborate
4. Tetrakis (2-methoxyisobutylisonitrile) Copper (i) Tetrafluoroborate
5. Cardioite
6. Copper Tetramibi Tetrafluoroborate
7. Cardiospect
8. Cardioite [who-dd]
9. N6ou7hj70p
10. Dtxsid601026679
11. Mfcd02092733
12. Db14106
13. Ft-0700047
14. Propane, 1-isocyano-2-methoxy-2-methyl-, Copper Complex
15. Tetrakis(1-isocyano-2-methoxy-2-methyl-propane)-copper(i) Tetrafluoroborate
16. Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate [ii]
17. Tetrakis(2-methoxyisobutylisonitril)copper (i) Tetrafluoroborate
18. Tetrakis (2-methoxy Isobutyl Isonitrile) Copper (i) Tetrafluoroborate
19. Tetrakis (2-methoxyisobutylisonitrile) Copper (i) Tetrafluoroborate,98%
20. Copper(1+), Tetrakis(1-(isocyano-.kappa.c)-2-methoxy-2-methylpropane)-, (t-4)-, Tetrafluoroborate(1-)
| Molecular Weight | 603.0 g/mol |
|---|---|
| Molecular Formula | C24H44BCuF4N4O4 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 13 |
| Rotatable Bond Count | 8 |
| Exact Mass | 602.268771 g/mol |
| Monoisotopic Mass | 602.268771 g/mol |
| Topological Polar Surface Area | 54.4 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 128 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 6 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30074
Submission : 2015-12-11
Status : Active
Type : II

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TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
NDC Package Code : 58272-200
Start Marketing Date : 2008-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
NDC Package Code : 65044-0020
Start Marketing Date : 2016-10-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
NDC Package Code : 50384-2804
Start Marketing Date : 2017-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
NDC Package Code : 50384-0700
Start Marketing Date : 2009-07-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (400g/400g)
Marketing Category : BULK INGREDIENT

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Regulatory Info : Marketed
Registration Country : Norway
Copper tetramibitetrafluoroborate
Brand Name : Stamicis
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
[Tetrakis (2-Metoxi-2-Methylpropyl-1-Isocyanide) Cobre (I)] Tetrafluoroborate De
Brand Name : Stamicis
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 1MG
Packaging :
Approval Date : 26-06-2009
Application Number : 71081
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Marketed
Registration Country : Norway
Copper tetramibitetrafluoroborate
Brand Name : Technescan Sestamibi
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

Regulatory Info : Marketed
Registration Country : Norway
Copper tetramibitetrafluoroborate
Brand Name : Sammibi
Dosage Form : Radiopharmaceutical Preparation Kits
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
[Tetrakis (2-Metoxi-2-Methylpropyl-1-Isocyanide) Cobre (I)] Tetrafluoroborate De
Brand Name : Mibi Institute Of Atomic Energy
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 1MG
Packaging :
Approval Date : 11-09-2009
Application Number : 71371
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
[Tetrakis (2-Metoxi-2-Methylpropyl-1-Isocyanide) Cobre (I)] Tetrafluoroborate De
Brand Name : Mibi Radiopharmacy Laboratory
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 500MCG
Packaging :
Approval Date : 02-04-2009
Application Number : 70755
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
[Tetrakis (2-Metoxi-2-Methylpropyl-1-Isocyanide) Cobre (I)] Tetrafluoroborate De
Brand Name : Mibi Technescan
Dosage Form : Reagent Kit For Pharmaceutical Preparation
Dosage Strength : 1MG
Packaging :
Approval Date : 10-10-2008
Application Number : 70132
Regulatory Info : Authorized
Registration Country : Spain

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Product Web Link
Virtual Booth
Digital Content
Website
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Regulatory Info : SCHEDULE C
Registration Country : Canada
Brand Name : KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION
Dosage Form : KIT
Dosage Strength : 1MG/VIAL
Packaging :
Approval Date :
Application Number : 2329794
Regulatory Info : SCHEDULE C
Registration Country : Canada

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Regulatory Info : SCHEDULE C
Registration Country : Canada
Brand Name : DRAXIMAGE SESTAMIBI
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1MG/VIAL
Packaging : 2/5/10 VIALS
Approval Date :
Application Number : 2327732
Regulatory Info : SCHEDULE C
Registration Country : Canada

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Regulatory Info : SCHEDULE C
Registration Country : Canada
Brand Name : CARDIOLITE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1MG/VIAL
Packaging : 2/5/20/30 X 5ML VIALS
Approval Date :
Application Number : 2328003
Regulatory Info : SCHEDULE C
Registration Country : Canada

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PharmaCompass offers a list of Copper TetraMIBI Tetrafluoroborate 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 Copper TetraMIBI Tetrafluoroborate manufacturer or Copper TetraMIBI Tetrafluoroborate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Copper TetraMIBI Tetrafluoroborate manufacturer or Copper TetraMIBI Tetrafluoroborate supplier.
A Copper TetraMIBI Tetrafluoroborate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copper TetraMIBI Tetrafluoroborate, including repackagers and relabelers. The FDA regulates Copper TetraMIBI Tetrafluoroborate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copper TetraMIBI Tetrafluoroborate 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 Copper TetraMIBI Tetrafluoroborate supplier is an individual or a company that provides Copper TetraMIBI Tetrafluoroborate active pharmaceutical ingredient (API) or Copper TetraMIBI Tetrafluoroborate finished formulations upon request. The Copper TetraMIBI Tetrafluoroborate suppliers may include Copper TetraMIBI Tetrafluoroborate API manufacturers, exporters, distributors and traders.
click here to find a list of Copper TetraMIBI Tetrafluoroborate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Copper TetraMIBI Tetrafluoroborate DMF (Drug Master File) is a document detailing the whole manufacturing process of Copper TetraMIBI Tetrafluoroborate active pharmaceutical ingredient (API) in detail. Different forms of Copper TetraMIBI Tetrafluoroborate DMFs exist exist since differing nations have different regulations, such as Copper TetraMIBI Tetrafluoroborate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copper TetraMIBI Tetrafluoroborate DMF submitted to regulatory agencies in the US is known as a USDMF. Copper TetraMIBI Tetrafluoroborate USDMF includes data on Copper TetraMIBI Tetrafluoroborate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copper TetraMIBI Tetrafluoroborate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copper TetraMIBI Tetrafluoroborate suppliers with USDMF on PharmaCompass.
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 Copper TetraMIBI Tetrafluoroborate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Copper TetraMIBI Tetrafluoroborate API and other APIs are published in this directory by the FDA.
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 Copper TetraMIBI Tetrafluoroborate 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.
The NDC directory also contains data on finished compounded human drug products that contain Copper TetraMIBI Tetrafluoroborate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Copper TetraMIBI Tetrafluoroborate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Copper TetraMIBI Tetrafluoroborate suppliers with NDC on PharmaCompass.
Copper TetraMIBI Tetrafluoroborate 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 Copper TetraMIBI Tetrafluoroborate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Copper TetraMIBI Tetrafluoroborate GMP manufacturer or Copper TetraMIBI Tetrafluoroborate GMP API supplier for your needs.
A Copper TetraMIBI Tetrafluoroborate CoA (Certificate of Analysis) is a formal document that attests to Copper TetraMIBI Tetrafluoroborate's compliance with Copper TetraMIBI Tetrafluoroborate specifications and serves as a tool for batch-level quality control.
Copper TetraMIBI Tetrafluoroborate CoA mostly includes findings from lab analyses of a specific batch. For each Copper TetraMIBI Tetrafluoroborate 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.
Copper TetraMIBI Tetrafluoroborate may be tested according to a variety of international standards, such as European Pharmacopoeia (Copper TetraMIBI Tetrafluoroborate EP), Copper TetraMIBI Tetrafluoroborate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Copper TetraMIBI Tetrafluoroborate USP).