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    Chemistry

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    Also known as: 27761-19-9, Cysteamine (bitartrate), Mercamine bitartrate, Chebi:50386, Rp-103, Schembl49513
    Molecular Formula
    C6H13NO6S
    Molecular Weight
    227.24  g/mol
    InChI Key
    NSKJTUFFDRENDM-UHFFFAOYSA-N
    Cysteamine Bitartrate
    A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.
    1 2D Structure

    Cysteamine Bitartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-aminoethanethiol;2,3-dihydroxybutanedioic acid
    2.1.2 InChI
    InChI=1S/C4H6O6.C2H7NS/c5-1(3(7)8)2(6)4(9)10;3-1-2-4/h1-2,5-6H,(H,7,8)(H,9,10);4H,1-3H2
    2.1.3 InChI Key
    NSKJTUFFDRENDM-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C(CS)N.C(C(C(=O)O)O)(C(=O)O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 2 Aminoethanethiol

    2. 2-aminoethanethiol

    3. 35s-labeled Cysteamine

    4. Becaptan

    5. Beta Mercaptoethylamine

    6. Beta-mercaptoethylamine

    7. Bitartrate, Cysteamine

    8. Cystagon

    9. Cysteamine

    10. Cysteamine Dihydrochloride

    11. Cysteamine Hydrobromide

    12. Cysteamine Hydrochloride

    13. Cysteamine Maleate (1:1)

    14. Cysteamine Tartrate

    15. Cysteamine Tartrate (1:1)

    16. Cysteamine Tosylate

    17. Cysteamine, 35s Labeled

    18. Cysteamine, 35s-labeled

    19. Cysteinamine

    20. Dihydrochloride, Cysteamine

    21. Hydrobromide, Cysteamine

    22. Hydrochloride, Cysteamine

    23. Mercamine

    24. Mercaptamine

    25. Mercaptoethylamine

    26. Tartrate, Cysteamine

    27. Tosylate, Cysteamine

    2.2.2 Depositor-Supplied Synonyms

    1. 27761-19-9

    2. Cysteamine (bitartrate)

    3. Mercamine Bitartrate

    4. Chebi:50386

    5. Rp-103

    6. Schembl49513

    7. Chembl2062263

    8. Bcp15048

    9. Akos024332936

    10. 2-aminoethanethiol 2,3-dihydroxysuccinate

    11. Db-114321

    12. Ft-0696891

    13. 2-aminoethanethiol;2,3-dihydroxybutanedioic Acid

    14. A900934

    15. Q27122045

    2.2.3 Other Synonyms

    1. Cysteamine (usan)

    2. Mecramine

    2.3 Create Date
    2007-12-05
    3 Chemical and Physical Properties
    Molecular Weight 227.24 g/mol
    Molecular Formula C6H13NO6S
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass227.04635831 g/mol
    Monoisotopic Mass227.04635831 g/mol
    Topological Polar Surface Area142 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity144
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Cystine Depleting Agents

    Compounds and drugs that react with CYSTINE and convert it into a compound that can be more easily metabolized or intracellularly transported. Drugs in this class have been used to treat CYSTINOSIS. (See all compounds classified as Cystine Depleting Agents.)

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    Cystine Disulfide Reduction [MoA]; Cystine Depleting Agent [EPC]

    API Reference Price

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    04-Jan-2021
    30-Mar-2025
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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 203389

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

    USFDA APPLICATION NUMBER - 203389

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    ABOUT THIS PAGE

    Looking for 27761-19-9 / Cysteamine Bitartrate API manufacturers, exporters & distributors?

    Cysteamine Bitartrate manufacturers, exporters & distributors 1

    87

    PharmaCompass offers a list of Cysteamine Bitartrate 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 Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier.

    PharmaCompass also assists you with knowing the Cysteamine Bitartrate API Price utilized in the formulation of products. Cysteamine Bitartrate API Price is not always fixed or binding as the Cysteamine Bitartrate Price is obtained through a variety of data sources. The Cysteamine Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Cysteamine Bitartrate

    Synonyms

    27761-19-9, Cysteamine (bitartrate), Mercamine bitartrate, Chebi:50386, Rp-103, Schembl49513

    Cas Number

    27761-19-9

    About Cysteamine Bitartrate

    A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.

    Cysteamine Tartrate Manufacturers

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

    click here to find a list of Cysteamine Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Cysteamine Tartrate Suppliers

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

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

    Cysteamine Tartrate USDMF

    A Cysteamine Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine Tartrate DMFs exist exist since differing nations have different regulations, such as Cysteamine Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Cysteamine Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine Tartrate USDMF includes data on Cysteamine Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Cysteamine Tartrate suppliers with USDMF on PharmaCompass.

    Cysteamine Tartrate 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 Cysteamine Tartrate Drug Master File in Japan (Cysteamine Tartrate JDMF) empowers Cysteamine Tartrate 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 Cysteamine Tartrate JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine Tartrate 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 Cysteamine Tartrate suppliers with JDMF on PharmaCompass.

    Cysteamine Tartrate NDC

    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 Cysteamine Tartrate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Cysteamine Tartrate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 Cysteamine Tartrate 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Cysteamine Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cysteamine Tartrate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Cysteamine Tartrate suppliers with NDC on PharmaCompass.

    Cysteamine Tartrate GMP

    Cysteamine Tartrate 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 Cysteamine Tartrate 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 Cysteamine Tartrate GMP manufacturer or Cysteamine Tartrate GMP API supplier for your needs.

    Cysteamine Tartrate CoA

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

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

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