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1. Urea-14c
2. 14c-urea
3. Urea C-14
4. Urea C 14
5. Carbon 14 Urea
6. Carbon-14 Urea
7. Urea ((sup 14)c)
8. Urea (14c)
9. 594-05-8
10. Urea 14 C
11. Diamino(114c)methanone
12. Wbz6m63tee
13. Pytest
14. Unii-wbz6m63tee
15. Urea C 14 [usp]
16. Pytest (tn)
17. Urea C14 (usp)
18. Chembl2096635
19. Urea 14 C [who-dd]
20. Urea, [14c]
21. Chebi:134711
22. Dtxsid701026303
23. Urea C 14 [usp Impurity]
24. Urea, C-14 [orange Book]
25. Db09513
26. D10496
27. Q27098010
| Molecular Weight | 62.048 g/mol |
|---|---|
| Molecular Formula | CH4N2O |
| XLogP3 | -1.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 62.03560474 g/mol |
| Monoisotopic Mass | 62.03560474 g/mol |
| Topological Polar Surface Area | 69.1 Ų |
| Heavy Atom Count | 4 |
| Formal Charge | 0 |
| Complexity | 29 |
| 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 |
| 1 of 2 | |
|---|---|
| Drug Name | Pytest |
| PubMed Health | 14C-Urea (By mouth) |
| Drug Classes | Diagnostic Agent, Helicobactor Pylori, Breath Test |
| Active Ingredient | Urea, c-14 |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 1uci |
| Market Status | Prescription |
| Company | Avent |
| 2 of 2 | |
|---|---|
| Drug Name | Pytest |
| PubMed Health | 14C-Urea (By mouth) |
| Drug Classes | Diagnostic Agent, Helicobactor Pylori, Breath Test |
| Active Ingredient | Urea, c-14 |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 1uci |
| Market Status | Prescription |
| Company | Avent |
14C-urea is intended for use in the detection of gastric urease as an aid in the diagnosis of Helicobacter pylori (H. pylori) infection in the human stomach. The test utilizes a liquid scintillation counter for the measurement of 14CO2 in breath samples.
FDA Label
14C-urea that is not hydrolyzed by H. pylori is excreted in the urine with a half-life of approximately 12 hours. About 10% of the 14C remains in the body at 72 hours and is gradually excreted with a biological half-life of 40 days.
The urease enzyme is not present in mammalian cells, so the presence of urease in the stomach is evidence that bacteria are present. The presence of urease is not specific for H. pylori, but other bacteria are not usually found in the stomach. To detect H. pylori, urea labeled with 14C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 14CO2 is absorbed into the blood and exhaled in the breath. Following ingestion of the capsule by a patient with H. pylori, 14CO2 excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. Therefore, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that urease is present in the stomach, and hence that H. pylori bacteria are present.
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PharmaCompass offers a list of Urea-14C API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Urea-14C manufacturer or Urea-14C supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urea-14C manufacturer or Urea-14C supplier.
PharmaCompass also assists you with knowing the Urea-14C API Price utilized in the formulation of products. Urea-14C API Price is not always fixed or binding as the Urea-14C Price is obtained through a variety of data sources. The Urea-14C Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Urea-14C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea-14C, including repackagers and relabelers. The FDA regulates Urea-14C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea-14C 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 Urea-14C supplier is an individual or a company that provides Urea-14C active pharmaceutical ingredient (API) or Urea-14C finished formulations upon request. The Urea-14C suppliers may include Urea-14C API manufacturers, exporters, distributors and traders.
Urea-14C 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 Urea-14C 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 Urea-14C GMP manufacturer or Urea-14C GMP API supplier for your needs.
A Urea-14C CoA (Certificate of Analysis) is a formal document that attests to Urea-14C's compliance with Urea-14C specifications and serves as a tool for batch-level quality control.
Urea-14C CoA mostly includes findings from lab analyses of a specific batch. For each Urea-14C 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.
Urea-14C may be tested according to a variety of international standards, such as European Pharmacopoeia (Urea-14C EP), Urea-14C JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urea-14C USP).
