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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

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Listed Suppliers

Other Suppliers

API REF. PRICE (USD/KG)

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MARKET PLACE

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FDF

0INTERMEDIATES

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FDA Orange Book

FDA (Orange Book)

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

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GLOBAL SALES INFORMATION

US Medicaid

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Finished Drug Prices

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Chemistry

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Also known as: Isalon, Dihydroxyaluminum allantoinate, Aluminum, ((2,5-dioxo-4-imidazolidinyl)ureato)dihydroxy-, Chlokale, Peptilate, Aldioxum [inn-latin]
Molecular Formula
C4H9AlN4O5
Molecular Weight
220.12  g/mol
InChI Key
AMZWNNKNOQSBOP-UHFFFAOYSA-M

Isalon
1 2D Structure

Isalon

2 Identification
2.1 Computed Descriptors
2.1.1 InChI
InChI=1S/C4H6N4O3.Al.2H2O/c5-3(10)6-1-2(9)8-4(11)7-1;;;/h1H,(H3,5,6,10)(H2,7,8,9,11);;2*1H2/q;+1;;/p-1
2.1.2 InChI Key
AMZWNNKNOQSBOP-UHFFFAOYSA-M
2.1.3 Canonical SMILES
C1(C(=O)NC(=N1)O[Al])NC(=O)N.O.O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Dihydroxyaluminum Allantoinate

2.2.2 Depositor-Supplied Synonyms

1. Isalon

2. Dihydroxyaluminum Allantoinate

3. Aluminum, ((2,5-dioxo-4-imidazolidinyl)ureato)dihydroxy-

4. Chlokale

5. Peptilate

6. Aldioxum [inn-latin]

7. Aldioxa [usan:inn:jan]

8. Aldioxum

9. Aluminum, (allantoinato)dihydroxy-

10. Aluminum, Dihydroxy(allantoinato)-

11. Einecs 226-964-4

12. Ascomp (tn)

13. Isalon (tn)

14. Dsstox_cid_31563

15. Dsstox_rid_97448

16. Unii-8t66i31ynk

17. Dsstox_gsid_57774

18. Schembl168685

19. Aldioxa (jp17/usan/inn)

20. ((2,5-dioxo-4-imidazolidinyl)ureato)dihydroxyaluminum

21. Chembl3188892

22. Dtxsid8057774

23. Dihydroxy(2-hydroxy-5-oxo-2-imidazolin-4-ylureato)aluminum

24. Tox21_113724

25. Ncgc00253586-01

26. Cas-5579-81-7

27. D02033

28. Aluminum, (n-(2,5-dioxo-4-imidazolidinyl)ureato)dihydroxy-

2.3 Create Date
2007-08-23
3 Chemical and Physical Properties
Molecular Weight 220.12 g/mol
Molecular Formula C4H9AlN4O5
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass220.0388328 g/mol
Monoisotopic Mass220.0388328 g/mol
Topological Polar Surface Area108 Ų
Heavy Atom Count14
Formal Charge0
Complexity256
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antacids

Substances that counteract or neutralize acidity of the GASTROINTESTINAL TRACT. (See all compounds classified as Antacids.)


Astringents

Agents, usually topical, that cause the contraction of tissues for the control of bleeding or secretions. (See all compounds classified as Astringents.)


Market Place

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ABOUT THIS PAGE

Isalon Manufacturers

A Isalon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isalon, including repackagers and relabelers. The FDA regulates Isalon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isalon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Isalon Suppliers

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

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

Isalon JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Isalon Drug Master File in Japan (Isalon JDMF) empowers Isalon API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Isalon JDMF during the approval evaluation for pharmaceutical products. At the time of Isalon JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Isalon suppliers with JDMF on PharmaCompass.

Isalon GMP

Isalon 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 Isalon 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 Isalon GMP manufacturer or Isalon GMP API supplier for your needs.

Isalon CoA

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

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

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