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Also known as: 50-34-0, Pro-banthine, Propantheline (bromide), Neometantyl, Neopepulsan, (2-hydroxyethyl)diisopropylmethylammonium bromide xanthene-9-carboxylate
Molecular Formula
C23H30BrNO3
Molecular Weight
448.4  g/mol
InChI Key
XLBIBBZXLMYSFF-UHFFFAOYSA-M
FDA UNII
UX9Z118X9F

Propantheline Bromide
A muscarinic antagonist used as an antispasmodic, in rhinitis, in urinary incontinence, and in the treatment of ulcers. At high doses it has nicotinic effects resulting in neuromuscular blocking.
1 2D Structure

Propantheline Bromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl-di(propan-2-yl)-[2-(9H-xanthene-9-carbonyloxy)ethyl]azanium;bromide
2.1.2 InChI
InChI=1S/C23H30NO3.BrH/c1-16(2)24(5,17(3)4)14-15-26-23(25)22-18-10-6-8-12-20(18)27-21-13-9-7-11-19(21)22;/h6-13,16-17,22H,14-15H2,1-5H3;1H/q+1;/p-1
2.1.3 InChI Key
XLBIBBZXLMYSFF-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CC(C)[N+](C)(CCOC(=O)C1C2=CC=CC=C2OC3=CC=CC=C13)C(C)C.[Br-]
2.2 Other Identifiers
2.2.1 UNII
UX9Z118X9F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bromide, Propantheline

2. Pro Banthine

3. Pro-banthine

4. Probanthine

5. Propantheline

2.3.2 Depositor-Supplied Synonyms

1. 50-34-0

2. Pro-banthine

3. Propantheline (bromide)

4. Neometantyl

5. Neopepulsan

6. (2-hydroxyethyl)diisopropylmethylammonium Bromide Xanthene-9-carboxylate

7. Nsc-757294

8. Mls000028703

9. Ux9z118x9f

10. 2-propanaminium, N-methyl-n-(1-methylethyl)-n-(2-((9h-xanthen-9-ylcarbonyl)oxy)ethyl)-, Bromide

11. Ncgc00094306-02

12. Smr000058661

13. Dsstox_cid_3519

14. Dsstox_rid_77062

15. Dsstox_gsid_23519

16. Ccris 6271

17. Nci-c56257

18. Cas-50-34-0

19. Sr-01000003171

20. Propanthelini Bromidum [inn-latin]

21. Einecs 200-030-6

22. Bromuro De Proantelina [inn-spanish]

23. Bromure De Propantheline [inn-french]

24. Sc-3171

25. Unii-ux9z118x9f

26. N-(2-(9h-xanthene-9-carbonyloxy)ethyl)-n-isopropyl-n-methylpropan-2-aminium Bromide

27. Propantheline,(s)

28. N-methyl-n-(1-methylethyl)-n-{2-[(9h-xanthen-9-ylcarbonyl)oxy]ethyl}propan-2-aminium Bromide

29. Prestwick_241

30. Mfcd00050291

31. Propantheline Bromide [usp:inn:ban:jan]

32. Opera_id_1667

33. Diisopropyl(2-hydroxyethyl)methylammonium Bromide Xanthene-9-carboxylate

34. Chembl1240

35. Xanthene-9-carboxylic Acid, Ester With (2-hydroxyethyl)diisopropylmethylammonium Bromide

36. Regid_for_cid_9279

37. Schembl40291

38. Mls001076547

39. Mls001333690

40. Spectrum1500511

41. Chebi:8482

42. Dtxsid2023519

43. Hms502i04

44. Hms1570f15

45. Hms1920l18

46. Hms2092c19

47. Hms2097f15

48. Hms2234m23

49. Hms3259e04

50. Hms3263k09

51. Hms3370n21

52. Hms3714f15

53. Hms3886k03

54. Pharmakon1600-01500511

55. Propantheline Bromide [mi]

56. Propantheline Bromide [inn]

57. Propantheline Bromide [jan]

58. Hy-b1188

59. Tox21_111265

60. Tox21_302331

61. Tox21_501014

62. Ccg-39238

63. Nsc757294

64. Propantheline Bromide [mart.]

65. Akos015895527

66. Ammonium, Diisopropyl(2-hydroxyethyl)methyl-, Bromide, Xanthene-9-carboxylate

67. Propantheline Bromide [usp-rs]

68. Propantheline Bromide [who-dd]

69. Tox21_111265_1

70. Cs-4797

71. Ks-1386

72. Lp01014

73. Nc00529

74. Nsc 757294

75. Propantheline Bromide (jp17/usp/inn)

76. Ncgc00015854-10

77. Ncgc00094306-01

78. Ncgc00094306-03

79. Ncgc00094306-04

80. Ncgc00094306-05

81. Ncgc00255145-01

82. Ncgc00261699-01

83. 2-propanaminium,n-methyl-n-(1-methylethyl)-n-[2-[(9h-xanthen-9-ylcarbonyl)oxy]ethyl]-,bromide

84. Ac-13428

85. Propantheline Bromide [ep Impurity]

86. Propantheline Bromide [orange Book]

87. Db-051756

88. Propantheline Bromide [usp Impurity]

89. Eu-0101014

90. Ft-0603218

91. Propantheline Bromide [usp Monograph]

92. Propantheline Bromide, >=97% (tlc), Powder

93. D00481

94. D82053

95. P 8891

96. A828073

97. Sr-01000003171-2

98. Sr-01000003171-4

99. Sr-01000003171-7

100. W-105970

101. Q27291318

102. Propantheline Bromide, United States Pharmacopeia (usp) Reference Standard

103. (2-hydroxyethyl)diisopropylmethylammonium Bromide Xanthene-9-carboxylate Bromide

104. Methyl-[2-[oxo(9h-xanthen-9-yl)methoxy]ethyl]-di(propan-2-yl)ammonium Bromide

105. Methyl-di(propan-2-yl)-[2-(9h-xanthen-9-ylcarbonyloxy)ethyl]azanium Bromide

106. Propantheline Bromide, Pharmaceutical Secondary Standard; Certified Reference Material

107. 2-propanaminium, N-methyl-n-(1-methylethyl)-n-(2-((9h-xanthen-9-ylcarbonyl)oxy)ethyl)-, Bromide (1:1)

108. N-isopropyl-n-methyl-n-(2-((9h-xanthen-9-ylcarbonyl)oxy)ethyl)propan-2-aminium Bromide

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 448.4 g/mol
Molecular Formula C23H30BrNO3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count7
Exact Mass447.14091 g/mol
Monoisotopic Mass447.14091 g/mol
Topological Polar Surface Area35.5 Ų
Heavy Atom Count28
Formal Charge0
Complexity474
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 2  
Drug NamePropantheline bromide
Drug LabelEach tablet for oral administration contains:Propantheline bromide.................................................. 15 mgPropantheline bromide, a synthetic quaternary ammonium compound, occurs as white or nearly white crystals. It is odorless and ha...
Active IngredientPropantheline bromide
Dosage FormTablet
RouteOral
Strength15mg
Market StatusPrescription
CompanyRoxane

2 of 2  
Drug NamePropantheline bromide
Drug LabelEach tablet for oral administration contains:Propantheline bromide.................................................. 15 mgPropantheline bromide, a synthetic quaternary ammonium compound, occurs as white or nearly white crystals. It is odorless and ha...
Active IngredientPropantheline bromide
Dosage FormTablet
RouteOral
Strength15mg
Market StatusPrescription
CompanyRoxane

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)


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.)


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19-Jan-2021
29-Jun-2024
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Propantheline Bromide Manufacturers

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

Propantheline Bromide Suppliers

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

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

Propantheline Bromide USDMF

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

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

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

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

Propantheline Bromide WC

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

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

Propantheline Bromide 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 Propantheline Bromide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Propantheline Bromide GMP

Propantheline Bromide 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 Propantheline Bromide 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 Propantheline Bromide GMP manufacturer or Propantheline Bromide GMP API supplier for your needs.

Propantheline Bromide CoA

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

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

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