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Chemistry

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Also known as: 34552-83-5, Loperamide hcl, Imodium, Suprasec, Loperamide (hydrochloride), Fortasec
Molecular Formula
C29H34Cl2N2O2
Molecular Weight
513.5  g/mol
InChI Key
PGYPOBZJRVSMDS-UHFFFAOYSA-N
FDA UNII
77TI35393C

Loperamide Hydrochloride
One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
1 2D Structure

Loperamide Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide;hydrochloride
2.1.2 InChI
InChI=1S/C29H33ClN2O2.ClH/c1-31(2)27(33)29(24-9-5-3-6-10-24,25-11-7-4-8-12-25)19-22-32-20-17-28(34,18-21-32)23-13-15-26(30)16-14-23;/h3-16,34H,17-22H2,1-2H3;1H
2.1.3 InChI Key
PGYPOBZJRVSMDS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)C(=O)C(CCN1CCC(CC1)(C2=CC=C(C=C2)Cl)O)(C3=CC=CC=C3)C4=CC=CC=C4.Cl
2.2 Other Identifiers
2.2.1 UNII
77TI35393C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Hydrochloride, Loperamide

2. Imodium

3. Loperamide

4. Loperamide Monohydrochloride

5. Monohydrochloride, Loperamide

6. R 18553

7. R-18553

8. R18553

2.3.2 Depositor-Supplied Synonyms

1. 34552-83-5

2. Loperamide Hcl

3. Imodium

4. Suprasec

5. Loperamide (hydrochloride)

6. Fortasec

7. Imodium A-d

8. 4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

9. Nsc-696356

10. Maalox Anti-diarrheal

11. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

12. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide;hydrochloride

13. Mls000069779

14. Chebi:6533

15. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Hydrochloride

16. R 18,553

17. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidine Butyramide Hcl

18. 77ti35393c

19. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenylpiperidine-1-butyramide Monohydrochloride

20. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutyramide Monohydrochloride

21. Dissenten

22. Lopemid

23. Lopemin

24. Loperyl

25. Smr000058466

26. Imosec

27. Tebloc

28. R-18553

29. Maalox Antidiarrheal

30. Blox

31. Brek

32. Diamode

33. Loseramin

34. Imotil

35. Anti-diarrheal

36. Kao-paverin

37. Diar-aid

38. Kaopectate 1-d

39. K-pek Ii

40. Pepto Diarrhea Control

41. Imodium A-d Ez Chews

42. Pj185

43. Sr-01000075507

44. Up And Up Anti Diarrheal

45. Einecs 252-082-4

46. C29h33cln2o2.hcl

47. Unii-77ti35393c

48. Loperamide, Hcl

49. R 18553

50. Prestwick_302

51. Imodium (tn)

52. Mfcd00058581

53. Cpd000058466

54. Loperamide Hydrochloride [usan:usp:jan]

55. Loperamidi Hydrochloridum

56. Opera_id_1508

57. 4-(4-(p-chlorophenyl)-4-hydroxy-1-piperidyl)-n,n-dimethyl-2,2-diphenylbutyramide Hcl

58. Chembl1707

59. Loperamidehydrochloride

60. Schembl15048

61. R-18553 (hydrochloride)

62. Mls001148627

63. Mls002222200

64. Spectrum2300241

65. Regid_for_cid_71420

66. Loperamide Hydrochloride ,(s)

67. Hy-b0418a

68. Dtxsid00880006

69. Hms1568m10

70. Hms1922j18

71. Pharmakon1600-02300241

72. Bcp28441

73. Loperamide Hydrochloride (jan/usp)

74. Tox21_500708

75. Ccg-39494

76. Loperamide Hydrochloride [mi]

77. Nsc696356

78. Nsc759568

79. S2480

80. Loperamide Hydrochloride [jan]

81. Akos015846351

82. Ac-8242

83. Adl 2-1294

84. Loperamide Hydrochloride [usan]

85. Lp00708

86. Nc00572

87. Nsc 759568

88. Nsc-759568

89. Loperamide Hydrochloride [mart.]

90. Loperamide Hydrochloride [vandf]

91. Loperamide Hydrochloride [usp-rs]

92. Loperamide Hydrochloride [who-dd]

93. Loperamide Hydrochloride [who-ip]

94. Ncgc00094059-01

95. Ncgc00094059-02

96. Ncgc00094059-03

97. Ncgc00094059-04

98. Ncgc00094059-05

99. Ncgc00180886-01

100. Ncgc00180886-02

101. Ncgc00261393-01

102. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-, Monohydrochloride

103. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Monohydrochloride

104. 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride

105. As-13181

106. Bl166178

107. B1392

108. Eu-0100708

109. Ft-0627973

110. L0154

111. Sw196602-3

112. Loperamide Hydrochloride [ep Impurity]

113. Loperamide Hydrochloride [orange Book]

114. D00729

115. D78217

116. L 4762

117. Loperamide Hydrochloride [ep Monograph]

118. Loperamide Hydrochloride [usp Monograph]

119. Loperamidi Hydrochloridum [who-ip Latin]

120. 552l835

121. A822272

122. Sr-01000075507-1

123. Sr-01000075507-3

124. Sr-01000075507-8

125. W-106729

126. Q27107231

127. Loperamide Hydrochloride, Vetranal(tm), Analytical Standard

128. Imodium Multi-symptom Relief Component Loperamide Hydrochloride

129. Loperamide Hydrochloride Component Of Imodium Multi-symptom Relief

130. Loperamide Hydrochloride, British Pharmacopoeia (bp) Reference Standard

131. Loperamide Hydrochloride, European Pharmacopoeia (ep) Reference Standard

132. 4-(4-chlorophenyl)-4-hydroxy-n,.alpha.-diphenyl-1-piperidinebutanamide Monohydrochloride

133. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-?,?-diphenyl-1-piperidinebutanamide Hydrochloride

134. Loperamide Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

135. Loperamide Hydrochloride, United States Pharmacopeia (usp) Reference Standard

136. 4-(4-chlorophenyl)-1-[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4-hydroxypiperidin-1-ium Chloride

137. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamide Hydrochloride

138. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamidehydrochloride

139. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-1-piperidinebutyramide Monohydrochloride

140. 4-[4-(4-chlorophenyl)-4-oxidanyl-piperidin-1-yl]-n,n-dimethyl-2,2-diphenyl-butanamide Hydrochloride

141. Loperamide Hydrochloride For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 513.5 g/mol
Molecular Formula C29H34Cl2N2O2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count7
Exact Mass512.1997337 g/mol
Monoisotopic Mass512.1997337 g/mol
Topological Polar Surface Area43.8 Ų
Heavy Atom Count35
Formal Charge0
Complexity623
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 8  
Drug NameImodium
Active IngredientLoperamide hydrochloride
Dosage FormCapsule
RouteOral
Strength2mg
Market StatusPrescription
CompanyMcneil Cons

2 of 8  
Drug NameImodium a-d ez chews
Active IngredientLoperamide hydrochloride
Dosage FormTablet, chewable
RouteOral
Strength2mg
Market StatusOver the Counter
CompanyMcneil

3 of 8  
Drug NameLoperamide hydrochloride
PubMed HealthLoperamide (By mouth)
Drug ClassesAntidiarrheal, Gastrointestinal Agent
Drug LabelLoperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s...
Active IngredientLoperamide hydrochloride
Dosage FormTablet; Capsule; Suspension; Solution
RouteOral
Strength1mg/5ml; 1mg; 2mg; 1mg/7.5ml
Market StatusOver the Counter; Prescription
CompanyWockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan

4 of 8  
Drug NameLoperamide hydrochloride and simethicone
Drug LabelIMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact...
Active Ingredientsimethicone; Loperamide hydrochloride
Dosage FormTablet; Tablet, chewable
RouteOral
Strength125mg; 2mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

5 of 8  
Drug NameImodium
Active IngredientLoperamide hydrochloride
Dosage FormCapsule
RouteOral
Strength2mg
Market StatusPrescription
CompanyMcneil Cons

6 of 8  
Drug NameImodium a-d ez chews
Active IngredientLoperamide hydrochloride
Dosage FormTablet, chewable
RouteOral
Strength2mg
Market StatusOver the Counter
CompanyMcneil

7 of 8  
Drug NameLoperamide hydrochloride
PubMed HealthLoperamide (By mouth)
Drug ClassesAntidiarrheal, Gastrointestinal Agent
Drug LabelLoperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s...
Active IngredientLoperamide hydrochloride
Dosage FormTablet; Capsule; Suspension; Solution
RouteOral
Strength1mg/5ml; 1mg; 2mg; 1mg/7.5ml
Market StatusOver the Counter; Prescription
CompanyWockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan

8 of 8  
Drug NameLoperamide hydrochloride and simethicone
Drug LabelIMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact...
Active Ingredientsimethicone; Loperamide hydrochloride
Dosage FormTablet; Tablet, chewable
RouteOral
Strength125mg; 2mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antidiarrheals

Miscellaneous agents found useful in the symptomatic treatment of diarrhea. They have no effect on the agent(s) that cause diarrhea, but merely alleviate the condition. (See all compounds classified as Antidiarrheals.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonists [MoA]; Opioid Agonist [EPC]

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07-Jan-2022
30-Apr-2025
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DOSAGE - TABLET;ORAL - 2MG

USFDA APPLICATION NUMBER - 19860

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DOSAGE - CAPSULE;ORAL - 1MG

USFDA APPLICATION NUMBER - 21855

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DOSAGE - CAPSULE;ORAL - 2MG

USFDA APPLICATION NUMBER - 21855

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ABOUT THIS PAGE

Looking for 34552-83-5 / Loperamide Hydrochloride API manufacturers, exporters & distributors?

Loperamide Hydrochloride manufacturers, exporters & distributors 1

30

PharmaCompass offers a list of Loperamide Hydrochloride 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 Loperamide Hydrochloride manufacturer or Loperamide Hydrochloride supplier for your needs.

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

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

API | Excipient name

Loperamide Hydrochloride

Synonyms

34552-83-5, Loperamide hcl, Imodium, Suprasec, Loperamide (hydrochloride), Fortasec

Cas Number

34552-83-5

Unique Ingredient Identifier (UNII)

77TI35393C

About Loperamide Hydrochloride

One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.

Imotil Manufacturers

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

Imotil Suppliers

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

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

Imotil USDMF

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

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

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

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

Imotil KDMF

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

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

After submitting a Imotil 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 Imotil API can apply through the Korea Drug Master File (KDMF).

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

Imotil CEP

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

A Imotil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Imotil 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 Imotil suppliers with CEP (COS) on PharmaCompass.

Imotil WC

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

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

Imotil 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 Imotil as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Imotil GMP

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

Imotil CoA

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

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

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