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1. Iodine-123(1-)
2. Iodide (123i(1-))
3. Iodide I-123
4. 69239-56-1
5. 98qpv8670c
6. I-123
7. Iodide-123
8. Unii-98qpv8670c
9. Iodine 123
10. Iodide I-123 Ion
11. Iodide Ion I 123
12. Iodide, I-123
13. Iodide Ion (123 I)
14. Dtxsid40988959
15. Db09420
16. 123i-
17. Q3801335
| Molecular Weight | 122.90559 g/mol |
|---|---|
| Molecular Formula | I- |
| XLogP3 | 0.9 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 122.90559 g/mol |
| Monoisotopic Mass | 122.90559 g/mol |
| Topological Polar Surface Area | 0 Ų |
| Heavy Atom Count | 1 |
| Formal Charge | -1 |
| Complexity | 0 |
| Isotope Atom Count | 1 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
FDA Label
Iodine-123 decays by electron capture with a physical half-life of 13.2 hours
Sodium Iodide I-123 is a radioactive isotope of iodine used in nuclear medicine for the diagnostic study of thyroid disease. Following oral administration, I-123 is absorbed through the gastrointestinal tract and is taken up by the thyroid gland. After incorporation, a gamma camera is used to detect the decay by electron capture to tellurium-123. Iodine is commonly used in thyroid function diagnostic tests as this gland normally absorbs iodine through the diet for formation of the thyroid hormones triiodothyronine (T3) and its prohormone, thyroxine (T4).
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23879
Submission : 2010-06-05
Status : Active
Type : II
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ABOUT THIS PAGE
A Iodide-123 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iodide-123, including repackagers and relabelers. The FDA regulates Iodide-123 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iodide-123 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 Iodide-123 supplier is an individual or a company that provides Iodide-123 active pharmaceutical ingredient (API) or Iodide-123 finished formulations upon request. The Iodide-123 suppliers may include Iodide-123 API manufacturers, exporters, distributors and traders.
click here to find a list of Iodide-123 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iodide-123 DMF (Drug Master File) is a document detailing the whole manufacturing process of Iodide-123 active pharmaceutical ingredient (API) in detail. Different forms of Iodide-123 DMFs exist exist since differing nations have different regulations, such as Iodide-123 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iodide-123 DMF submitted to regulatory agencies in the US is known as a USDMF. Iodide-123 USDMF includes data on Iodide-123's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iodide-123 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iodide-123 suppliers with USDMF on PharmaCompass.
Iodide-123 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 Iodide-123 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 Iodide-123 GMP manufacturer or Iodide-123 GMP API supplier for your needs.
A Iodide-123 CoA (Certificate of Analysis) is a formal document that attests to Iodide-123's compliance with Iodide-123 specifications and serves as a tool for batch-level quality control.
Iodide-123 CoA mostly includes findings from lab analyses of a specific batch. For each Iodide-123 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.
Iodide-123 may be tested according to a variety of international standards, such as European Pharmacopoeia (Iodide-123 EP), Iodide-123 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iodide-123 USP).
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