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    Chemistry

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    Also known as: Tolterodine tartrate, 124937-52-6, Detrol la, Detrusitol, Tolterodine l-tartrate, Pnu-200583e
    Molecular Formula
    C26H37NO7
    Molecular Weight
    475.6  g/mol
    InChI Key
    TWHNMSJGYKMTRB-KXYUELECSA-N
    FDA UNII
    5T619TQR3R
    Tolterodine Tartrate
    An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.
    1 2D Structure

    Tolterodine Tartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R)-2,3-dihydroxybutanedioic acid;2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
    2.1.2 InChI
    InChI=1S/C22H31NO.C4H6O6/c1-16(2)23(17(3)4)14-13-20(19-9-7-6-8-10-19)21-15-18(5)11-12-22(21)24;5-1(3(7)8)2(6)4(9)10/h6-12,15-17,20,24H,13-14H2,1-5H3;1-2,5-6H,(H,7,8)(H,9,10)/t20-;1-,2-/m11/s1
    2.1.3 InChI Key
    TWHNMSJGYKMTRB-KXYUELECSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=C(C=C1)O)C(CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(C(C(=O)O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CC1=CC(=C(C=C1)O)[C@H](CCN(C(C)C)C(C)C)C2=CC=CC=C2.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    5T619TQR3R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Detrol La

    2. Detrusitol

    3. Pha 686464b

    4. Pha-686464b

    5. Pha686464b

    6. Tartrate, Tolterodine

    7. Tolterodine

    8. Tolterodine Tartrate

    9. Unidet

    10. Urotrol

    2.3.2 Depositor-Supplied Synonyms

    1. Tolterodine Tartrate

    2. 124937-52-6

    3. Detrol La

    4. Detrusitol

    5. Tolterodine L-tartrate

    6. Pnu-200583e

    7. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol (2r,3r)-2,3-dihydroxysuccinate

    8. Tolterodine Tartrate [usan]

    9. Kabi-2234

    10. Urotrol

    11. 5t619tqr3r

    12. Pnu 200583e

    13. Tolterodine Tartrate (detrol La)

    14. 124937-52-6 (tartrate)

    15. Tolterodine (tartrate)

    16. (r)-2-(3-diisopropylamino-1-phenyl-propyl)-p-cresol L-tartrate

    17. (r)-2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methylphenol (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1) (salt)

    18. (+)-(r)-2-(i-(2-(diisopropylamino)ethyl)benzyl)-p-cresol L-tartrate (1:1) (salt)

    19. Unii-5t619tqr3r

    20. (2r,3r)-2,3-dihydroxybutanedioic Acid;2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol

    21. Detrusitol Sr

    22. Mfcd07771985

    23. (r)-2-[3-(diisopropylamino)-1-phenylpropyl]-4-methylphenol L-tartrate

    24. Detrusitol (tn)

    25. Detrol (tn)

    26. Tolterodine, Tartrate

    27. (tolterodine Tartrate)

    28. Detrol La;kabi-2234;pnu-200583e

    29. Tolterodine Tartrate,(s)

    30. (r)-tolterodine L-tartrate

    31. Tolterodine Tartrate- Bio-x

    32. Mls003915640

    33. Schembl467372

    34. Chembl1200871

    35. Tolterodine Tartrate (jan/usp)

    36. Dtxsid80924972

    37. Tolterodine Tartrate [mi]

    38. Hms3715n08

    39. Hms3884j08

    40. Tolterodine Tartrate [jan]

    41. Tolterodine Tartrate [vandf]

    42. S2550

    43. Tolterodine Tartrate [mart.]

    44. Tolterodine Tartrate [usp-rs]

    45. Akos015961803

    46. Ac-2617

    47. Ccg-221263

    48. Cs-0441

    49. Ds-1398

    50. Tolterodine L-tartrate [who-dd]

    51. Tolterodine L-tartrate 124937-51-5

    52. (2r,3r)-2,3-dihydroxybutanedioic Acid,2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol

    53. As-35344

    54. Bt164484

    55. Hy-90010

    56. Phenol, 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (2r,3r)-2,3-dihydroxybutanedioate (1:1) (salt)

    57. Phenol, 2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (r)-, (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1) (salt)

    58. Smr002544692

    59. Tolterodine L-tartrate, >=98% (hplc)

    60. Tolterodine Tartrate [orange Book]

    61. Bcp0726000292

    62. Tolterodine Tartrate [ep Monograph]

    63. Tolterodine Tartrate [usp Monograph]

    64. Sw197495-2

    65. D01148

    66. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-

    67. 4-methylphenol (2r,3r)-2,3-dihydroxysuccinate

    68. 937t526

    69. A890340

    70. J-500064

    71. Q27114836

    72. (+)-(r)-2-(a-[2-(diisopropylamino)ethyl]benzyl)-p-cresol Tartrate

    73. (+)-r)-2-{a-(2-(diisopropylamino)ethyl)benzyl}-p-cresol Tartrate

    74. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol(2r,3r)-2,3-dihydroxysuccinate

    75. (r)-2-(3-diisopropylamino-1-phenyl-propyl)-4-methyl-phenol L-tartrate

    76. 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol (2r,3r)-2,3-dihydroxybutanedioate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 475.6 g/mol
    Molecular Formula C26H37NO7
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count10
    Exact Mass475.25700252 g/mol
    Monoisotopic Mass475.25700252 g/mol
    Topological Polar Surface Area139 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity474
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 6  
    Drug NameDetrol
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelDETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxyb...
    Active IngredientTolterodine tartrate
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 6  
    Drug NameDetrol la
    Drug LabelDETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrat...
    Active IngredientTolterodine tartrate
    Dosage FormCapsule, extended release
    RouteOral
    Strength4mg; 2mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    3 of 6  
    Drug NameTolterodine tartrate
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelTolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-(R)-2-[I-[2-(Diisopropylamino)ethyl]benzyl]-p-cresol L-tartrate (1:1) (sa...
    Active IngredientTolterodine tartrate
    Dosage FormTablet; Capsule, extended release
    Routeoral; Oral
    Strength1mg; 4mg; 2mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Sandoz

    4 of 6  
    Drug NameDetrol
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelDETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxyb...
    Active IngredientTolterodine tartrate
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    5 of 6  
    Drug NameDetrol la
    Drug LabelDETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrat...
    Active IngredientTolterodine tartrate
    Dosage FormCapsule, extended release
    RouteOral
    Strength4mg; 2mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    6 of 6  
    Drug NameTolterodine tartrate
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelTolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-(R)-2-[I-[2-(Diisopropylamino)ethyl]benzyl]-p-cresol L-tartrate (1:1) (sa...
    Active IngredientTolterodine tartrate
    Dosage FormTablet; Capsule, extended release
    Routeoral; Oral
    Strength1mg; 4mg; 2mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Sandoz

    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]

    API Reference Price

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    06-Feb-2021
    21-Dec-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 20771

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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 20771

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2MG

    USFDA APPLICATION NUMBER - 21228

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 4MG

    USFDA APPLICATION NUMBER - 21228

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    ABOUT THIS PAGE

    Tolterodine Tartrate Manufacturers

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

    Tolterodine Tartrate Suppliers

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

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

    Tolterodine Tartrate USDMF

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

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

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

    Tolterodine Tartrate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Tolterodine Tartrate Drug Master File in Korea (Tolterodine Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tolterodine Tartrate. The MFDS reviews the Tolterodine Tartrate KDMF as part of the drug registration process and uses the information provided in the Tolterodine Tartrate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Tolterodine Tartrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tolterodine Tartrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Tolterodine Tartrate suppliers with KDMF on PharmaCompass.

    Tolterodine Tartrate CEP

    A Tolterodine Tartrate CEP of the European Pharmacopoeia monograph is often referred to as a Tolterodine Tartrate Certificate of Suitability (COS). The purpose of a Tolterodine Tartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tolterodine Tartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tolterodine Tartrate to their clients by showing that a Tolterodine Tartrate CEP has been issued for it. The manufacturer submits a Tolterodine Tartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tolterodine Tartrate CEP holder for the record. Additionally, the data presented in the Tolterodine Tartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tolterodine Tartrate DMF.

    A Tolterodine Tartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tolterodine Tartrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Tolterodine Tartrate suppliers with CEP (COS) on PharmaCompass.

    Tolterodine Tartrate WC

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

    click here to find a list of Tolterodine Tartrate suppliers with Written Confirmation (WC) on PharmaCompass.

    Tolterodine 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 Tolterodine Tartrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Tolterodine Tartrate GMP

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

    Tolterodine Tartrate CoA

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

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

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