Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00678)
Name
Tinidazole
Synonyms    Click to Show/Hide the Synonyms of This API
tinidazole; 19387-91-8; Tindamax; Fasigyn; 1-(2-(Ethylsulfonyl)ethyl)-2-methyl-5-nitro-1H-imidazole; Trimonase; Tinidazolum; 1-(2-ethylsulfonylethyl)-2-methyl-5-nitroimidazole; 1H-Imidazole, 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-; 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazole; timidazole; UNII-033KF7V46H; Tinidazol; CP-12574; CHEBI:63627; CP-12,574; 1-(2-(Ethylsulfonyl)ethyl)-2-methyl-5-nitroimidazole; MLS000069717; Bioshik; Fasigin; Simplotan; Tricolam; 1H-Imidazole, 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-; 033KF7V46H; 1-(2-ethylsulfonylethyl)-2-methyl-5-nitro-imidazole; Imidazole, 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-; NCGC00016741-01; 1-[2-(ethanesulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazole; SMR000058194; Sorquetan; Pletil; CAS-19387-91-8; DSSTox_CID_3676; DSSTox_RID_77141; DSSTox_GSID_23676; 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole; 1-(ethylsulfonyl)-2-(2-methyl-5-nitroimidazolyl)ethane; 1-[2'-(Ethylsulfonyl)-Ethyl]-2-Methyl-5-Nitroimidazole; Glongyn; Amtiba; CP 12574; Tinidazol [INN-Spanish]; Tinidazolum [INN-Latin]; CCRIS 7621; HSDB 7362; SR-01000000210; EINECS 243-014-4; BRN 0618182; 1-(2'-(ethylsulfonyl)-Ethyl]-2-Methyl-5-Nitroimidazole; Symplotan; Ethyl (2-(2-methyl-5-nitro-1-imidazolyl)ethyl)sulfone; Fasigyntrade mark; Tindamaxtrade mark; Tinidazole,(S); Simplotantrade mark; Haisigyn (TN); Tindamax (TN); Prestwick_136; Tinidazole [USAN:USP:INN:BAN:JAN]; Spectrum_001266; Opera_ID_779; SpecPlus_000708; Prestwick0_000766; Prestwick1_000766; Prestwick2_000766; Prestwick3_000766; Spectrum2_000648; Spectrum3_001512; Spectrum4_000230; Spectrum5_001715; CHEMBL1220; Oprea1_342844; SCHEMBL21141; BSPBio_000812; BSPBio_003183; KBioGR_000899; KBioSS_001746; methyl-5-nitro-1H-imidazole; 5-23-05-00067 (Beilstein Handbook Reference); MLS001146883; MLS001424192; DivK1c_006804; SPECTRUM1502127; SPBio_000655; SPBio_002751; BPBio1_000894; Tinidazole (JP17/USP/INN); DTXSID4023676; KBio1_001748; KBio2_001746; KBio2_004314; KBio2_006882; KBio3_002683; 1-(2-(ethylsulfonyl)ethyl)-2-; HMS1570I14; HMS1921L06; HMS2052C09; HMS2090B14; HMS2092D14; HMS2097I14; HMS2231E23; HMS3374P07; HMS3394C09; HMS3652A08; HMS3714I14; Pharmakon1600-01502127; ZINC113446; BCP20694; HY-B0177; Tox21 110586; Tox21_110586; BBL010767; BDBM50248360; CCG-39907; MFCD00057217; NSC758189; STK801761; AKOS000747070; Tox21_110586_1; AC-1618; CS-2055; DB00911; KS-5180; MCULE-2580495783; NC00346; NSC-758189; NCGC00016741-02; NCGC00016741-03; NCGC00016741-04; NCGC00016741-05; NCGC00016741-06; NCGC00016741-07; NCGC00016741-09; NCGC00022212-03; NCGC00022212-04; NCGC00022212-05; AK114670; ST024770; Tinidazole 100 microg/mL in Acetonitrile; SBI-0052674.P002; AB0012837; AB00053176; FT-0675241; SW196447-4; VU0239922-6; D01426; K-5725; Tinidazole, VETRANAL(TM), analytical standard; AB00053176-16; AB00053176_17; AB00053176_18; A813669; Q1321320; SR-01000000210-3; SR-01000000210-5; SR-01000000210-6; 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazol; BRD-K89125793-001-05-4; Z56763819; Tinidazole, European Pharmacopoeia (EP) Reference Standard; Tinidazole, United States Pharmacopeia (USP) Reference Standard
Clinical Status
Approved
Disease Indication Amebiasis ICD-11: 1A36 [1]
PubChem CID
5479
Formula
C8H13N3O4S
Canonical SMILES
CCS(=O)(=O)CCN1C(=NC=C1[N+](=O)[O-])C
InChI
1S/C8H13N3O4S/c1-3-16(14,15)5-4-10-7(2)9-6-8(10)11(12)13/h6H,3-5H2,1-2H3
InChIKey
HJLSLZFTEKNLFI-UHFFFAOYSA-N
   Click to Show/Hide the Molecular Data (Structure/Property) of This API
Structure
<iframe style="width: 300px; height: 300px;" frameborder="0" src="https://embed.molview.org/v1/?mode=balls&cid=5479"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 247.27 Topological Polar Surface Area 106
XlogP -0.4 Complexity 345
Heavy Atom Count 16 Rotatable Bond Count 4
Hydrogen Bond Donor Count 0 Hydrogen Bond Acceptor Count 5
Full List of Drug Formulations (DFMs) Containing This API
          Tinidazole 500 mg tablet Click to Show/Hide the Full List of Formulation(s):          8 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Hypromellose; Cellulose, microcrystalline; Polydextrose; Polyethylene glycol; Starch, corn
                   Dosage Form Oral Tablet
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Hypromellose DIG Info Cytochrome P450 3A5 (IC50 = 19.4 uM) [4]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Pack Pharmaceuticals; Rising Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Aluminum oxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Biocomp Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Aluminum oxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Department of State Health Services, Pharmacy Branch; Mission Pharmacal Company
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 5 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Magnesium stearate; Talc; Titanium dioxide; Croscarmellose sodium; Polyvinyl alcohol; Cellulose, microcrystalline; Polyethylene glycol 3000; Starch, corn
                   Dosage Form Oral Tablet
                   Company GAVIS Pharmaceuticals; Novel Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Polyvinyl alcohol DIG Info Debrisoquine 4-hydroxylase (EC50 = 354.8 uM) [4]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 6 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Povidone k30; Silicon dioxide; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Starch, corn
                   Dosage Form Oral Tablet
                   Company Ingenus Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
             Drug Formulation 7 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Povidone k30; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Edenbridge Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
             Drug Formulation 8 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Titanium dioxide; Triacetin; Water; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Povidone k12
                   Dosage Form Oral Tablet
                   Company West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
          Tinidazole 250 mg tablet Click to Show/Hide the Full List of Formulation(s):          7 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Pack Pharmaceuticals; Rising Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Aluminum oxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Biocomp Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Fd&c yellow no. 6; Magnesium stearate; Titanium dioxide; Triacetin; Croscarmellose sodium; Aluminum oxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Mission Pharmacal Company
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Fd&c red no. 40; Magnesium stearate; Talc; Titanium dioxide; Croscarmellose sodium; Polyvinyl alcohol; Cellulose, microcrystalline; Polyethylene glycol 3000; Starch, corn
                   Dosage Form Oral Tablet
                   Company GAVIS Pharmaceuticals; Novel Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Polyvinyl alcohol DIG Info Debrisoquine 4-hydroxylase (EC50 = 354.8 uM) [4]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
             Drug Formulation 5 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Povidone k30; Silicon dioxide; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Starch, corn
                   Dosage Form Oral Tablet
                   Company Ingenus Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
             Drug Formulation 6 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Ferric oxide yellow; Titanium dioxide; Croscarmellose sodium; Povidone k30; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols; Starch, corn
                   Dosage Form Oral Tablet
                   Company Edenbridge Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
             Drug Formulation 7 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Titanium dioxide; Triacetin; Water; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polydextrose; Polyethylene glycols; Povidone k12
                   Dosage Form Oral Tablet
                   Company West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [5]
References
1 FDA label for approved tinidazole from the official website of the U.S. Food and Drug Administration.
2 The activities of drug inactive ingredients on biological targets. Science. 2020 Jul 24;369(6502):403-413.
3 Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives. Proc Natl Acad Sci U S A. 2020 Jul 7;117(27):16009-16018.
4 Mediation of in vitro cytochrome p450 activity by common pharmaceutical excipients. Mol Pharm. 2013 Jul 1;10(7):2739-48.
5 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.

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