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    Chemistry

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    Also known as: Darifenacin hbr, 133099-07-7, Emselex, Darifenacin (hydrobromide), Darifenacin hydrobromide [usan], Cr02eyq8gv
    Molecular Formula
    C28H31BrN2O2
    Molecular Weight
    507.5  g/mol
    InChI Key
    UQAVIASOPREUIT-VQIWEWKSSA-N
    FDA UNII
    CR02EYQ8GV
    Darifenacin Hydrobromide
    1 2D Structure

    Darifenacin Hydrobromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide
    2.1.2 InChI
    InChI=1S/C28H30N2O2.BrH/c29-27(31)28(23-7-3-1-4-8-23,24-9-5-2-6-10-24)25-14-17-30(20-25)16-13-21-11-12-26-22(19-21)15-18-32-26;/h1-12,19,25H,13-18,20H2,(H2,29,31);1H/t25-;/m1./s1
    2.1.3 InChI Key
    UQAVIASOPREUIT-VQIWEWKSSA-N
    2.1.4 Canonical SMILES
    C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br
    2.1.5 Isomeric SMILES
    C1CN(C[C@@H]1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br
    2.2 Other Identifiers
    2.2.1 UNII
    CR02EYQ8GV
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide

    2. Darifenacin

    3. Darifenacin Hydrochloride

    4. Darifenacine

    5. Darifenicin

    6. Emselex

    7. Enablex

    8. Uk-88525

    2.3.2 Depositor-Supplied Synonyms

    1. Darifenacin Hbr

    2. 133099-07-7

    3. Emselex

    4. Darifenacin (hydrobromide)

    5. Darifenacin Hydrobromide [usan]

    6. Cr02eyq8gv

    7. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide Hydrobromide

    8. Uk-88525-04 (hydrobromide)

    9. Chebi:31455

    10. Uk-88525-04 (hbr)

    11. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide Hydrobromide

    12. 133099-07-7 (hbr)

    13. Dsstox_cid_26780

    14. Dsstox_rid_81899

    15. Dsstox_gsid_46780

    16. (s)-2-{1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl}-2,2-diphenylacetamide Hydrobromide

    17. Uk-88525

    18. Darilong

    19. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide

    20. Uk 88525-04 Hydrobromide

    21. Cas-133099-07-7

    22. Ncgc00168775-01

    23. Unii-cr02eyq8gv

    24. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hydrobromide

    25. 2-{(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide Hydrobromide

    26. Enablex (tn)

    27. Darifenacinhydrobromide

    28. Diphenyl-acetamide Hydrobromide

    29. Darifenacin Hydrobromide- Bio-x

    30. Chembl1200935

    31. Dtxsid9046780

    32. Hy-a0012

    33. Tox21_112636

    34. Darifenacin Hydrobromide (jan/usan)

    35. Darifenacin Hydrobromide [mi]

    36. Mfcd08141803

    37. S3144

    38. Darifenacin Hydrobromide [jan]

    39. Akos015969311

    40. Tox21_112636_1

    41. Ac-1894

    42. Ccg-220969

    43. Cs-0380

    44. Darifenacin Hydrobromide [mart.]

    45. Darifenacin Hydrobromide [usp-rs]

    46. Darifenacin Hydrobromide [who-dd]

    47. Ncgc00263922-02

    48. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (3s)-

    49. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (s)-

    50. 3-pyrrolidineacetamide, 1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-alpha,alpha-diphenyl-, Hydrobromide (1:1), (3s)-

    51. As-35087

    52. Bd164350

    53. Darifenacin Hydrobromide [ema Epar]

    54. Darifenacin Hydrobromide, >=98% (hplc)

    55. Sw219426-1

    56. Darifenacin Hydrobromide [orange Book]

    57. Uk-88525-04

    58. D01699

    59. Q-101006

    60. Q27114313

    61. Z1691545283

    62. Darifenacin Hydrobromide, United States Pharmacopeia (usp) Reference Standard

    63. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hbr

    64. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohbr, (3s)-

    65. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohydrobromide, (3s)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 507.5 g/mol
    Molecular Formula C28H31BrN2O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count7
    Exact Mass506.15689 g/mol
    Monoisotopic Mass506.15689 g/mol
    Topological Polar Surface Area55.6 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity607
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 NameDarifenacin hydrobromide
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    Routeoral
    Strength7.5mg; 15mg
    Market StatusTentative Approval
    CompanyAnchen Pharms

    2 of 4  
    Drug NameEnablex
    PubMed HealthDarifenacin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 15mg base; eq 7.5mg base
    Market StatusPrescription
    CompanyWarner Chilcott

    3 of 4  
    Drug NameDarifenacin hydrobromide
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    Routeoral
    Strength7.5mg; 15mg
    Market StatusTentative Approval
    CompanyAnchen Pharms

    4 of 4  
    Drug NameEnablex
    PubMed HealthDarifenacin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 15mg base; eq 7.5mg base
    Market StatusPrescription
    CompanyWarner Chilcott

    4.2 Drug Indication

    Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]
    5.3 ATC Code

    G04BD10

    API Reference Price

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    24-Mar-2021
    28-Apr-2025
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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21513

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21513

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    ABOUT THIS PAGE

    Looking for 133099-07-7 / Darifenacin Hydrobromide API manufacturers, exporters & distributors?

    Darifenacin Hydrobromide manufacturers, exporters & distributors 1

    34

    PharmaCompass offers a list of Darifenacin Hydrobromide 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 Darifenacin Hydrobromide manufacturer or Darifenacin Hydrobromide supplier for your needs.

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

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

    API | Excipient name

    Darifenacin Hydrobromide

    Synonyms

    Darifenacin hbr, 133099-07-7, Emselex, Darifenacin (hydrobromide), Darifenacin hydrobromide [usan], Cr02eyq8gv

    Cas Number

    133099-07-7

    Unique Ingredient Identifier (UNII)

    CR02EYQ8GV

    UK-88525 Manufacturers

    A UK-88525 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UK-88525, including repackagers and relabelers. The FDA regulates UK-88525 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UK-88525 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 UK-88525 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    UK-88525 Suppliers

    A UK-88525 supplier is an individual or a company that provides UK-88525 active pharmaceutical ingredient (API) or UK-88525 finished formulations upon request. The UK-88525 suppliers may include UK-88525 API manufacturers, exporters, distributors and traders.

    click here to find a list of UK-88525 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    UK-88525 USDMF

    A UK-88525 DMF (Drug Master File) is a document detailing the whole manufacturing process of UK-88525 active pharmaceutical ingredient (API) in detail. Different forms of UK-88525 DMFs exist exist since differing nations have different regulations, such as UK-88525 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A UK-88525 DMF submitted to regulatory agencies in the US is known as a USDMF. UK-88525 USDMF includes data on UK-88525's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The UK-88525 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of UK-88525 suppliers with USDMF on PharmaCompass.

    UK-88525 WC

    A UK-88525 written confirmation (UK-88525 WC) is an official document issued by a regulatory agency to a UK-88525 manufacturer, verifying that the manufacturing facility of a UK-88525 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting UK-88525 APIs or UK-88525 finished pharmaceutical products to another nation, regulatory agencies frequently require a UK-88525 WC (written confirmation) as part of the regulatory process.

    click here to find a list of UK-88525 suppliers with Written Confirmation (WC) on PharmaCompass.

    UK-88525 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 UK-88525 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for UK-88525 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 UK-88525 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 UK-88525 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a UK-88525 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of UK-88525 suppliers with NDC on PharmaCompass.

    UK-88525 GMP

    UK-88525 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 UK-88525 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 UK-88525 GMP manufacturer or UK-88525 GMP API supplier for your needs.

    UK-88525 CoA

    A UK-88525 CoA (Certificate of Analysis) is a formal document that attests to UK-88525's compliance with UK-88525 specifications and serves as a tool for batch-level quality control.

    UK-88525 CoA mostly includes findings from lab analyses of a specific batch. For each UK-88525 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.

    UK-88525 may be tested according to a variety of international standards, such as European Pharmacopoeia (UK-88525 EP), UK-88525 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (UK-88525 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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