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1. Colircusi Tropicamida
2. Minims Tropicamide
3. Mydral
4. Mydriafair
5. Mydriaticum
6. Mydrum
7. N-ethyl-alpha-(hydroxymethyl)-n-(4-pyridinylmethyl)benzeneacetamide
8. N-ethyl-n-(4-pyridylmethyl)tropamide
9. Ocu Tropic
10. Ocu-tropic
11. Ocutropic
12. Tropicacyl
13. Tropicamide Faure
14. Tropicamide Minims
15. Tropicamide Monofree
16. Tropicamide Monohydrochloride, (r)-isomer
17. Tropicamide Monohydrochloride, (s)-isomer
18. Tropicamide, (+-)-isomer
19. Tropicamide, (r)-isomer
20. Tropicamide, (s)-isomer
1. 1508-75-4
2. Mydriacyl
3. Mydriaticum
4. Bistropamide
5. Tropicacyl
6. Visumidriatic
7. N-ethyl-3-hydroxy-2-phenyl-n-(pyridin-4-ylmethyl)propanamide
8. Tropicamidum
9. Ro 1-7683
10. N-ethyl-2-phenyl-n-(4-pyridylmethyl)hydracrylamide
11. Mydriafair
12. Minims Tropicamide
13. Epitromina
14. Tropikamid
15. Mydrum
16. Nsc-757372
17. N0a3z5xtc6
18. Tropimil
19. Ncgc00016065-07
20. Tropicamida
21. Ro-1-7683
22. Benzeneacetamide, N-ethyl-.alpha.-(hydroxymethyl)-n-(4-pyridinylmethyl)-
23. Dsstox_cid_25220
24. Dsstox_rid_80757
25. Dsstox_gsid_45220
26. Tropicamidum [inn-latin]
27. Tropicamida [inn-spanish]
28. Tropicamid
29. Mydriacyl (tn)
30. N-ethyl-n-(4-pyridylmethyl)tropamid
31. N-ethyl-n-(4-pyridylmethyl)tropamide
32. Smr000058523
33. Sr-01000075351
34. Einecs 216-140-2
35. Unii-n0a3z5xtc6
36. N-ethyl-alpha-(hydroxymethyl)-n-(4-pyridinylmethyl)benzeneacetamide
37. Brn 0285563
38. Tropicamide, Solid
39. Benzeneacetamide, N-ethyl-alpha-(hydroxymethyl)-n-(4-pyridinylmethyl)-
40. Prestwick_487
41. Cas-1508-75-4
42. Component Of Paremyd
43. Mfcd00058580
44. Hydracrylamide, N-ethyl-2-phenyl-n-(4-pyridylmethyl)-
45. Tropicamide [usan:usp:inn:ban:jan]
46. (+-)-n-ethyl-2-phenyl-n-(4-pyridylmethyl)hydracrylamide
47. Spectrum_000584
48. Tropicamide [mi]
49. Prestwick0_000228
50. Prestwick1_000228
51. Prestwick2_000228
52. Prestwick3_000228
53. Spectrum2_000936
54. Spectrum3_000655
55. Spectrum4_000377
56. Spectrum5_001585
57. Tropicamide [inn]
58. Tropicamide [jan]
59. Tropicamide [usan]
60. T 9778
61. Tropicamide [vandf]
62. Tropicamide [mart.]
63. Lopac0_001223
64. Schembl23975
65. Bspbio_000275
66. Bspbio_002289
67. Kbiogr_000873
68. Kbioss_001064
69. Tropicamide [usp-rs]
70. Tropicamide [who-dd]
71. Tropicamide [who-ip]
72. 5-22-09-00359 (beilstein Handbook Reference)
73. Mls001306442
74. Mls002154240
75. Divk1c_000448
76. Spectrum1500599
77. Spbio_000872
78. Spbio_002196
79. Bpbio1_000303
80. Chebi:9757
81. Gtpl7319
82. Tropicamide (jp17/usp/inn)
83. Chembl1200604
84. Dtxsid8045220
85. Bdbm82371
86. Hms501g10
87. Kbio1_000448
88. Kbio2_001064
89. Kbio2_003632
90. Kbio2_006200
91. Kbio3_001509
92. Tropicamide [orange Book]
93. Ninds_000448
94. Hms1568n17
95. Hms1921i09
96. Hms2089m05
97. Hms2092a18
98. Hms2095n17
99. Hms2235j15
100. Hms3259m18
101. Hms3263f08
102. Hms3267a13
103. Hms3373b07
104. Hms3411f14
105. Hms3651k04
106. Hms3675f14
107. Hms3712n17
108. Hms3742c05
109. Hms3884e16
110. Pharmakon1600-01500599
111. Tropicamide [ep Monograph]
112. Tropicamide For Peak Identification
113. Tropicamide [usp Monograph]
114. Bcp13504
115. Hy-b0321
116. Nsc_5593
117. Paremyd Component Tropicamide
118. Tropicamidum [who-ip Latin]
119. Tox21_110297
120. Tox21_501223
121. Ac-816
122. Bbl028074
123. Ccg-40076
124. Nsc757372
125. S1913
126. Stk934612
127. Akos005664076
128. Tox21_110297_1
129. Am84467
130. Db00809
131. Ks-5174
132. Lp01223
133. Nc00589
134. Nsc 757372
135. Sdccgsbi-0051190.p004
136. Tropicamide Component Of Paremyd
137. Benzeneacetamide, N-ethyl-alpha-(hydroxymethyl)-n-(4-pyridinylmethyl)-, (+-)-
138. Idi1_000448
139. Smp1_000304
140. Ncgc00016065-03
141. Ncgc00016065-04
142. Ncgc00016065-05
143. Ncgc00016065-06
144. Ncgc00016065-08
145. Ncgc00016065-09
146. Ncgc00016065-11
147. Ncgc00016065-22
148. Ncgc00024866-02
149. Ncgc00024866-03
150. Ncgc00024866-04
151. Ncgc00024866-05
152. Ncgc00024866-06
153. Ncgc00261908-01
154. Cas_1508-75-4
155. Sbi-0051190.p003
156. Ab00052120
157. Eu-0101223
158. Ft-0657590
159. Sw196691-3
160. T1470
161. C72868
162. D00397
163. Q29310
164. Ab00052120-10
165. Ab00052120_11
166. Ab00052120_12
167. 508t754
168. L001262
169. N-ethyl-2-phenyl-n-(4-pyridylmethyl Hydracrylamide
170. Q-201902
171. Sr-01000075351-1
172. Sr-01000075351-3
173. Sr-01000075351-5
174. Sr-01000075351-7
175. Brd-a79672927-001-05-8
176. Brd-a79672927-001-10-8
177. Tropicamide, European Pharmacopoeia (ep) Reference Standard
178. N-ethyl-3-hydroxy-2-phenyl-n-(4-pyridinylmethyl)propanamide #
179. (+/-)-n-ethyl-2-phenyl-n-(4-pyridylmethyl)hydracrylamide
180. Tropicamide, United States Pharmacopeia (usp) Reference Standard
181. Benzeneacetamide, N-ethyl-.alpha.-(hydroxymethyl)-n-(4-pyridinylmethyl)-, (+/-)-
182. Tropicamide For Peak Identification, European Pharmacopoeia (ep) Reference Standard
| Molecular Weight | 284.35 g/mol |
|---|---|
| Molecular Formula | C17H20N2O2 |
| XLogP3 | 1.5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 6 |
| Exact Mass | 284.152477885 g/mol |
| Monoisotopic Mass | 284.152477885 g/mol |
| Topological Polar Surface Area | 53.4 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 310 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Mydriacyl |
| PubMed Health | Atropine, Homatropine, and Scopolamine (Ophthalmic route) |
| Drug Classes | Mydriatic-Cycloplegic |
| Drug Label | MYDRIACYL (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:Each mL contains: Active: tropicamide 0.5% or... |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Alcon |
| 2 of 8 | |
|---|---|
| Drug Name | Paremyd |
| PubMed Health | Tropicamide (Into the eye) |
| Active Ingredient | tropicamide; Hydroxyamphetamine hydrobromide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 1%; 0.25% |
| Market Status | Prescription |
| Company | Akorn |
| 3 of 8 | |
|---|---|
| Drug Name | Tropicacyl |
| Drug Label | MYDRIACYL (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:Each mL contains: Active: tropicamide 0.5% or... |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Akorn |
| 4 of 8 | |
|---|---|
| Drug Name | Tropicamide |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Bausch And Lomb |
| 5 of 8 | |
|---|---|
| Drug Name | Mydriacyl |
| PubMed Health | Atropine, Homatropine, and Scopolamine (Ophthalmic route) |
| Drug Classes | Mydriatic-Cycloplegic |
| Drug Label | MYDRIACYL (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:Each mL contains: Active: tropicamide 0.5% or... |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Alcon |
| 6 of 8 | |
|---|---|
| Drug Name | Paremyd |
| PubMed Health | Tropicamide (Into the eye) |
| Active Ingredient | tropicamide; Hydroxyamphetamine hydrobromide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 1%; 0.25% |
| Market Status | Prescription |
| Company | Akorn |
| 7 of 8 | |
|---|---|
| Drug Name | Tropicacyl |
| Drug Label | MYDRIACYL (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:Each mL contains: Active: tropicamide 0.5% or... |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Akorn |
| 8 of 8 | |
|---|---|
| Drug Name | Tropicamide |
| Active Ingredient | Tropicamide |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5%; 1% |
| Market Status | Prescription |
| Company | Bausch And Lomb |
Tropicamide is indicated to induce mydriasis (dilation of the pupil) and cycloplegia (paralysis of the ciliary muscle of the eye) in diagnostic procedures. It is used in combination with [hydroxyamphetamine] for the same indication.
Tropicamide is an anticholinergic drug and that works by nonselectively blocking muscarinic receptors to cause mydriasis and cycloplegia. It relaxes the pupillary sphincter to dilate the pupil. The onset of tropicamideinduced mydriasis is about 10 to 15 minutes, with optimal effect occurring 25 to 30 minutes post-administration. Mydriasis caused by tropicamide wears off within four to eight hours, but it was seen up to 24 hours in some individuals. Tropicamide causes accommodation by causing contraction of the ciliary muscle. The cycloplegic effect occurs within 20 to minutes following administration, with a duration of action of four to 10 hours. Tropicamide can elevate intraocular pressure. The ophthalmic use of tropicamide is not typically associated with serious systemic adverse events. One randomized pilot study showed that oral tropicamide alleviated perceived symptoms of sialorrhea in patients with Parkinson's Disease: anticholinergics are believed to restore the dopaminergic to cholinergic activity imbalance in neurodegenerative diseases. Similarly in one case report, tropicamide administered via ophthalmic solution relieved clozapine-induced sialorrhea. Interestingly, in rodent models, tropicamide suppressed drug-induced tremulous jaw movements which are often used as a model of parkinsonian tremor: the significance of this finding requires further investigations.
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.)
Mydriatics
Agents that dilate the pupil. They may be either sympathomimetics or parasympatholytics. (See all compounds classified as Mydriatics.)
S01FA06
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
S - Sensory organs
S01 - Ophthalmologicals
S01F - Mydriatics and cycloplegics
S01FA - Anticholinergics
S01FA06 - Tropicamide
Absorption
Following ocular administration of 40 L drops of 0.5% tropicamide in female subjects, tropicamide reached its mean peak concentration in plasma of 2.8 1.7 ng/mL (mean SD) at five minutes.
Route of Elimination
No information can be found.
Volume of Distribution
No information can be found.
Clearance
No information can be found.
No information can be found.
Tropicamide has a plasma half-life of 30minutes.
Muscarinic acetylcholine receptors are involved in numerous ocular functions. The M3 subtype is predominantly expressed by smooth muscle cells of the sphincter pupillae, which is a circular muscle of the iris, and ciliary muscles. In response to light or binding of acetylcholine, M3 receptor signalling leads to contraction of the sphincter pupillae and pupil constriction. Contraction of the ciliary muscle via M3 receptor signalling also leads to accommodation, adjusting the lens for near vision. The eye is also innervated by parasympathetic nerves: ciliary ganglion neurons project to the ciliary body and the sphincter pupillae muscle of the iris to control ocular accommodation and pupil constriction. Tropicamide is a non-selective muscarinic antagonist that binds to all subtypes of muscarinic receptors. By binding to muscarinic receptors, tropicamide relaxes the pupillary sphincter muscle and causes pupil dilation. By blocking the muscarinic receptors of the ciliary body, tropicamide also prevents accommodation. Like other muscarinic antagonists, tropicamide inhibits the parasympathetic drive, allowing the sympathetic nervous system responses to dominate. Tropicamide is thought to ameliorate sialorrhea by blocking M4 receptors expressed on salivary glands and reducing hypersalivation.
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Regulatory Info :
Registration Country : Canada
Brand Name : MYDRIACYL
Dosage Form : SOLUTION
Dosage Strength : 1%/W/V
Packaging : 15ML
Approval Date :
Application Number : 1007
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MYDRIACYL
Dosage Form : SOLUTION
Dosage Strength : 0.5%/W/V
Packaging : 15ML
Approval Date :
Application Number : 981
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MINIMS TROPICAMIDE
Dosage Form : DROPS
Dosage Strength : 1%/W/V
Packaging :
Approval Date :
Application Number : 2148536
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ODAN-TROPICAMIDE
Dosage Form : SOLUTION
Dosage Strength : 1%
Packaging : 15ML
Approval Date :
Application Number : 622885
Regulatory Info :
Registration Country : Canada
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tropicamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tropicamide, including repackagers and relabelers. The FDA regulates Tropicamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tropicamide 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 Tropicamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tropicamide supplier is an individual or a company that provides Tropicamide active pharmaceutical ingredient (API) or Tropicamide finished formulations upon request. The Tropicamide suppliers may include Tropicamide API manufacturers, exporters, distributors and traders.
click here to find a list of Tropicamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tropicamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tropicamide active pharmaceutical ingredient (API) in detail. Different forms of Tropicamide DMFs exist exist since differing nations have different regulations, such as Tropicamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tropicamide DMF submitted to regulatory agencies in the US is known as a USDMF. Tropicamide USDMF includes data on Tropicamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tropicamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tropicamide suppliers with USDMF on PharmaCompass.
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 Tropicamide Drug Master File in Japan (Tropicamide JDMF) empowers Tropicamide 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 Tropicamide JDMF during the approval evaluation for pharmaceutical products. At the time of Tropicamide 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 Tropicamide suppliers with JDMF on PharmaCompass.
A Tropicamide CEP of the European Pharmacopoeia monograph is often referred to as a Tropicamide Certificate of Suitability (COS). The purpose of a Tropicamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tropicamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tropicamide to their clients by showing that a Tropicamide CEP has been issued for it. The manufacturer submits a Tropicamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tropicamide CEP holder for the record. Additionally, the data presented in the Tropicamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tropicamide DMF.
A Tropicamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tropicamide 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 Tropicamide suppliers with CEP (COS) on PharmaCompass.
A Tropicamide written confirmation (Tropicamide WC) is an official document issued by a regulatory agency to a Tropicamide manufacturer, verifying that the manufacturing facility of a Tropicamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tropicamide APIs or Tropicamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Tropicamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Tropicamide suppliers with Written Confirmation (WC) on PharmaCompass.
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 Tropicamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tropicamide API and other APIs are published in this directory by the FDA.
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 Tropicamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Tropicamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tropicamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tropicamide suppliers with NDC on PharmaCompass.
Tropicamide 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 Tropicamide 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 Tropicamide GMP manufacturer or Tropicamide GMP API supplier for your needs.
A Tropicamide CoA (Certificate of Analysis) is a formal document that attests to Tropicamide's compliance with Tropicamide specifications and serves as a tool for batch-level quality control.
Tropicamide CoA mostly includes findings from lab analyses of a specific batch. For each Tropicamide 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.
Tropicamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Tropicamide EP), Tropicamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tropicamide USP).
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