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1. 1-(2'-hydroxypropyl)-2-methyl-5- Nitroimidazole
2. 14,539 Rp
3. Minovag
4. Sabima
5. Secnidal
6. Secnol
7. Solosec
1. 3366-95-8
2. Secnidazol
3. Flagentyl
4. Secnidazolum
5. 1-(2-methyl-5-nitro-1h-imidazol-1-yl)propan-2-ol
6. Secnidazolum [inn-latin]
7. Solosec
8. Rp 14539
9. Secnidal
10. 1-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol
11. Pm 185184
12. Pm-185184
13. Sym-1219
14. Secnidazole Anhydrous
15. Rp-14539
16. Secnidazole (flagentyl)
17. Ornidazole Metabolite M4
18. 1-(2-methyl-5-nitro-1-imidazolyl)-2-propanol
19. Nsc-759812
20. Mls000559043
21. 1-(2-methyl-5-nitro-imidazol-1-yl)-propan-2-ol
22. R3459k699k
23. Ncgc00095158-01
24. Smr000149359
25. Rp-14539;pm-185184
26. Dsstox_cid_25934
27. Dsstox_rid_81233
28. Dsstox_gsid_45934
29. Secnidazol [inn-spanish]
30. Cas-3366-95-8
31. Sr-01000685111
32. Einecs 222-134-0
33. Alpha,2-dimethyl-5-nitro-1h-imidazole-1-ethanol
34. Sindose
35. Secnil
36. Unii-r3459k699k
37. 1-(2-hydroxypropyl)-2-methyl-5-nitroimidazol
38. Secnidal (tn)
39. Secnidazole-[d6]
40. Secnidazole [usan:inn:ban:dcf]
41. Sym 1219
42. Solosec (tn)
43. Secnidazole [mi]
44. Opera_id_1811
45. Spectrum2_000033
46. Spectrum3_001956
47. Secnidazole [inn]
48. Alpha,2-dimethyl-5-nitroimidazole-1-ethanol
49. Secnidazole (usan/inn)
50. Secnidazole [usan]
51. 1-(2-methyl-5-nitroimidazol-1-yl)-2-propanol
52. Imidazole-1-ethanol, Alpha,2-dimethyl-5-nitro-
53. Secnidazole [mart.]
54. Bspbio_003556
55. Secnidazole [who-dd]
56. Mls000759496
57. Mls001201813
58. Mls001424126
59. Mls006011434
60. Schembl363924
61. Spectrum1505304
62. Spbio_000125
63. 1h-imidazole-1-ethanol, .alpha.,2-dimethyl-5-nitro-
64. Chembl498847
65. Dtxsid3045934
66. Chebi:94433
67. Kbio3_002874
68. Secnidazole [orange Book]
69. Chebi:140628
70. Hms1922b12
71. Hms2051c20
72. Hms2090n15
73. Hms2231g11
74. Hms3369n08
75. Hms3393c20
76. Hms3656g14
77. Hms3714i05
78. Pharmakon1600-01505304
79. Bcp12459
80. Hy-b1118
81. Tox21_111457
82. Bbl010784
83. Bdbm50349330
84. Ccg-39993
85. Mfcd00864656
86. Nsc759812
87. Stk590474
88. Akos005512552
89. Akos025149490
90. Tox21_111457_1
91. Ccg-100896
92. Cs-4641
93. Db12834
94. Ks-1191
95. Nc00146
96. Nsc 759812
97. Sb19197
98. Secnidazole 100 Microg/ml In Methanol
99. Ncgc00095158-02
100. Ncgc00095158-03
101. Ncgc00095158-04
102. Ncgc00095158-05
103. Ncgc00095158-08
104. Ac-12065
105. Sbi-0207037.p001
106. Secnidazole 100 Microg/ml In Acetonitrile
107. Db-000688
108. Ft-0601624
109. S2537
110. Sw197526-3
111. D07353
112. 1-(2- Hydroxypropyl)-2-methyl-5-nitroimidazole
113. 1h-imidazole-1-ethanol, A,2-dimethyl-5-nitro-
114. Ab00456738-13
115. Ab00456738-15
116. Ab00456738_16
117. Ab00456738_17
118. 366s958
119. A821901
120. J-019291
121. Q4413249
122. Sr-01000685111-4
123. Sr-01000685111-6
124. Sr-01000685111-7
125. .alpha.,2-dimethyl-5-nitroimidazole-1-ethanol
126. Brd-a70083328-001-02-9
127. Brd-a70083328-001-12-8
128. 1-(2-methyl-5-nitro-1h-imidazol-1-yl) Propan-2- Ol
129. 1-(2-methyl-5-nitro-imidazol-1-yl)propan-2-ol;secnidazole
| Molecular Weight | 185.18 g/mol |
|---|---|
| Molecular Formula | C7H11N3O3 |
| XLogP3 | 0.2 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 2 |
| Exact Mass | 185.08004122 g/mol |
| Monoisotopic Mass | 185.08004122 g/mol |
| Topological Polar Surface Area | 83.9 Ų |
| Heavy Atom Count | 13 |
| Formal Charge | 0 |
| Complexity | 194 |
| 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 |
Secnidazole is indicated for the treatment of trichomoniasis in adults and bacterial vaginosis in adult women.
FDA Label
Secnidazole is a nitroimidazole antimicrobial drug that displays selectivity against many anaerobic Gram-positive and Gram-negative bacteria and protozoa. In vitro studies demonstrates the effectiveness of the drug against *Bacteroides fragilis*, *Trichomonas vaginalis*, *Entamoeba histolytica* and *Giardia lamblia*. There is no significant bacterial or protozoal resistance reported from secnidazole treatment.
Antiprotozoal Agents
Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)
P01AB07
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
P - Antiparasitic products, insecticides and repellents
P01 - Antiprotozoals
P01A - Agents against amoebiasis and other protozoal diseases
P01AB - Nitroimidazole derivatives
P01AB07 - Secnidazole
Absorption
Secnidazole is rapidly and completely absorbed after oral administration. Following a single oral dose of 2 g in healthy adult female subjects, the mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg x hr/mL was reached. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours.
Route of Elimination
The predominant route of elimination is renal elimination. Following a single oral dose of 2g secnidazole, approximately 15% of the drug is excreted as unchanged compoung in the urine.
Volume of Distribution
The apparent volume of distribution of secnidazole is approximately 42-49 L.
Clearance
The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min.
According to *in vitro* studies, secnidazole is metabolized via oxidation by human hepatic CYP450 enzyme system with 1% conversion to metabolites.
The plasma elimination half-life for secnidazole is approximately 17 hours.
Secnidazole enters the bacterial cell as a prodrug without an antimicrobial activity. The drug is converted to an active form via reduction of nitro groups to radical anions by bacterial enzymes. The radical anions are thought to interfere with bacterial DNA synthesis of susceptible isolates.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27383
Submission : 2013-08-01
Status : Active
Type : II
NDC Package Code : 49964-0047
Start Marketing Date : 2016-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19450
Submission : 2006-05-16
Status : Active
Type : II
NDC Package Code : 14799-2008
Start Marketing Date : 2010-08-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49574-526
Start Marketing Date : 2019-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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ABOUT THIS PAGE
A Secnidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Secnidazole, including repackagers and relabelers. The FDA regulates Secnidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Secnidazole 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 Secnidazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Secnidazole supplier is an individual or a company that provides Secnidazole active pharmaceutical ingredient (API) or Secnidazole finished formulations upon request. The Secnidazole suppliers may include Secnidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Secnidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Secnidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Secnidazole active pharmaceutical ingredient (API) in detail. Different forms of Secnidazole DMFs exist exist since differing nations have different regulations, such as Secnidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Secnidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Secnidazole USDMF includes data on Secnidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Secnidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Secnidazole suppliers with USDMF 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 Secnidazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Secnidazole 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 Secnidazole 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 Secnidazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Secnidazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Secnidazole suppliers with NDC on PharmaCompass.
Secnidazole 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 Secnidazole 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 Secnidazole GMP manufacturer or Secnidazole GMP API supplier for your needs.
A Secnidazole CoA (Certificate of Analysis) is a formal document that attests to Secnidazole's compliance with Secnidazole specifications and serves as a tool for batch-level quality control.
Secnidazole CoA mostly includes findings from lab analyses of a specific batch. For each Secnidazole 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.
Secnidazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Secnidazole EP), Secnidazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Secnidazole USP).
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