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    Chemistry

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    Also known as: Colestid, Cholestabyl, 37296-80-3, Colestipol hydrochloride [usan:usp], Lestid, Flavored colestid
    Molecular Formula
    C8H24ClN5
    Molecular Weight
    225.76  g/mol
    InChI Key
    GACQNVJDWUAPFY-UHFFFAOYSA-N
    Colestipol
    Highly crosslinked and insoluble basic anion exchange resin used as anticholesteremic. It may also may reduce triglyceride levels.
    1 2D Structure

    Colestipol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;hydrochloride
    2.1.2 InChI
    InChI=1S/C8H23N5.ClH/c9-1-3-11-5-7-13-8-6-12-4-2-10;/h11-13H,1-10H2;1H
    2.1.3 InChI Key
    GACQNVJDWUAPFY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C(CNCCNCCNCCN)N.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Colestid

    2. Colestipol

    3. Colestipol Hcl

    4. Hcl, Colestipol

    5. Hydrochloride, Colestipol

    6. U 26,597 A

    7. U-26,597 A

    8. U26,597 A

    2.2.2 Depositor-Supplied Synonyms

    1. Colestid

    2. Cholestabyl

    3. 37296-80-3

    4. Colestipol Hydrochloride [usan:usp]

    5. Lestid

    6. Flavored Colestid

    7. N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;hydrochloride

    8. U-26597a

    9. Unii-x7d10k905g

    10. Tetraethylenepentamine Hcl

    11. Copolymer Of Diethylenetriamine And 1-chloro-2,3-epoxypropane, Hydrochloride (with Approximately 1 Out Of 5 Amine Nitrogens Protonated)

    12. Schembl284758

    13. Dtxsid40190737

    14. X7d10k905g

    15. Ft-0749664

    2.3 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 225.76 g/mol
    Molecular Formula C8H24ClN5
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count10
    Exact Mass225.1720235 g/mol
    Monoisotopic Mass225.1720235 g/mol
    Topological Polar Surface Area88.1 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity78.6
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameColestipol hydrochloride
    Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
    Active IngredientColestipol hydrochloride
    Dosage FormTablet; Granule
    RouteOral
    Strength1gm; 5gm/scoopful; 5gm/packet
    Market StatusPrescription
    CompanyImpax Labs

    2 of 4  
    Drug NameFlavored colestid
    Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
    Active IngredientColestipol hydrochloride
    Dosage FormGranule
    RouteOral
    Strength5gm/scoopful; 5gm/packet
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    3 of 4  
    Drug NameColestipol hydrochloride
    Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
    Active IngredientColestipol hydrochloride
    Dosage FormTablet; Granule
    RouteOral
    Strength1gm; 5gm/scoopful; 5gm/packet
    Market StatusPrescription
    CompanyImpax Labs

    4 of 4  
    Drug NameFlavored colestid
    Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
    Active IngredientColestipol hydrochloride
    Dosage FormGranule
    RouteOral
    Strength5gm/scoopful; 5gm/packet
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anion Exchange Resins

    High-molecular-weight insoluble polymers that contain functional cationic groups capable of undergoing exchange reactions with anions. (See all compounds classified as Anion Exchange Resins.)

    Hypolipidemic Agents

    Substances that lower the levels of certain LIPIDS in the BLOOD. They are used to treat HYPERLIPIDEMIAS. (See all compounds classified as Hypolipidemic Agents.)

    Sequestering Agents

    Compounds that bind to and reduce the biological availability of a chemical or pharmaceutical agent. (See all compounds classified as Sequestering Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Bile-acid Binding Activity [MoA]; Bile Acid Sequestrant [EPC]

    API Reference Price

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    08-Feb-2021
    05-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    DOSAGE - GRANULE;ORAL - 5GM/PACKET

    USFDA APPLICATION NUMBER - 17563

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    DOSAGE - TABLET;ORAL - 1GM

    USFDA APPLICATION NUMBER - 20222

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    ABOUT THIS PAGE

    Colestipol Manufacturers

    A Colestipol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colestipol, including repackagers and relabelers. The FDA regulates Colestipol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colestipol 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 Colestipol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Colestipol Suppliers

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

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

    Colestipol USDMF

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

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

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

    Colestipol 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 Colestipol as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Colestipol 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 Colestipol 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 Colestipol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colestipol NDC to their finished compounded human drug products, they may choose to do so.

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

    Colestipol GMP

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

    Colestipol CoA

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

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

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