Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00666)
Name
Testosterone
Synonyms    Click to Show/Hide the Synonyms of This API
testosterone; 58-22-0; Testosteron; Androderm; Testim; Testoderm; Mertestate; Virosterone; Androlin; Oreton; AndroGel; Synandrol F; Testostosterone; Andropatch; Malerone; Testogel; Testoviron; trans-Testosterone; Relibra; Cristerone T; LibiGel; 17beta-Hydroxyandrost-4-en-3-one; Oreton-F; Testoject-50; Testosterona; Testosteronum; Striant; Andro 100; Testex; Testosterone hydrate; Sustason 250; beta testosterone; Sustanon; Malestrone (amps); Testosteroid; Andronaq; Andrusol; Homosteron; Homosterone; Intrinsa; Orquisteron; Perandren; Primotest; Primoteston; Sustanone; Testandrone; Testobase; Testopropon; Testrone; Virormone; Teslen; Testryl; Testiculosterone; Malogen, aquaspension injection; Cristerona T; Testoviron T; Testosteronum [INN-Latin]; Testosterona [INN-Spanish]; Neotestis; Testoviron Schering; Geno-cristaux gremy; Neo-Hombreol F; Androst-4-en-17beta-ol-3-one; Testolin; Percutacrine androgenique; 17beta-Hydroxy-4-androsten-3-one; 7-beta-Hydroxyandrost-4-en-3-one; COL 1621; delta4-Androsten-17beta-ol-3-one; Androst-4-en-3-one, 17-hydroxy-, (17beta)-; 17beta-Hydroxyandrost-4-ene-3-one; 17-beta-Hydroxyandrost-4-en-3-one; 4-Androsten-17beta-ol-3-one; Testro AQ; 17-Hydroxy-(17beta)-androst-4-en-3-one; 17beta-Hydroxy-delta(sup4)-androsten-3-one; delta(sup 4)-Androsten-17(beta)-ol-3-one; 17-Hydroxy-(17-beta)-androst-4-en-3-one; UNII-3XMK78S47O; 17-beta-Hydroxy-delta(sup 4)-androsten-3-one; Androst-4-en-3-one, 17beta-hydroxy-; Androst-4-en-3-one, 17-beta-hydroxy-; CHEBI:17347; (17beta)-17-Hydroxyandrost-4-en-3-one; Neo-testis; Testoderm Tts; 3XMK78S47O; Androst-4-en-3-one, 17-hydroxy-, (17b)-; Testopel Pellets; CDB 111C; Testosterone and its esters; Halotensin; Fortesta; Nasobol; Natesto; Vogelxo; (+)-testosterone; Axiron; Tefina; CompleoTRT; CP 601B; (8alpha,10alpha,13alpha,14beta,17alpha)-17-hydroxyandrost-4-en-3-one; Androderm (TN); Androgel 1%; 17.beta.-Testosterone; Androgel (TN); SMR000058344; CCRIS 574; Striant (TN); Bio-T-Gel; AA 2500; Testim (TN); Androgel 1.62%; HSDB 3398; NSC 9700; Androst-4-en-3-one, 17-hydroxy-, (17.beta.)-; EINECS 200-370-5; Testosterone (JAN/USP); Androst-4-en-3-on-17B-ol; CHEMBL386630; component of Duogen (Salt/Mix); component of Tostrex (Salt/Mix); component of Di-Met (Salt/Mix); component of Intrinsa (Salt/Mix); 4-Androsten-17.beta.-ol-3-one; 4-Androsten-3-one-17.beta.-ol; Tlando; component of Di-Genik (Salt/Mix); 4-Androsten-3-one, 17b-hydroxy-; NSC-9700; Testosterone [USP:INN:BAN]; component of Mal-O-Fem (Salt/Mix); Testosterone [Androgenic steroids, anabolic]; 4-androstene-17beta-ol-3-one; Testosterone ciii; 17b-hydroxy-4-androsten-3-one; delta4-androsten-17b-ol-3-one; LPCN 1021; testosterone group; Testosterone, 1; 17-.beta.-Hydroxyandrost-4-en-3-one; NCGC00091018-01; Androst-4-en-3-one, 17-hydroxy-, (17-beta)-; Axiron (TN); CMC_13449; 17.beta.-Hydroxy-.DELTA.4-androsten-3-one; 17-Hydroxyandrost-4-en-3-one, (17.beta.)-; Testosterone, >=98%; DSSTox_CID_2371; Epitope ID:135865; EC 200-370-5; Testosterone EP Impurity C; SCHEMBL8452; DSSTox_RID_76563; DSSTox_GSID_22371; MLS000563091; MLS001032098; MLS001306401; MLS001424262; MLS002174283; BIDD:ER0555; BDBM8885; GTPL2858; DTXSID8022371; 17beta-hydroxy-4-androsten-3one; Testosterone, cell culture tested; HMS2052N11; HMS2272B03; HMS2272P03; Tox21_200689; HY-15554A; LMST02020002; RB3046; AKOS015894897; ZINC118912393; CCG-101189; CS-1415; DB00624; MCULE-1294118086; NC00439; CAS-58-22-0; Testosterone 1.0 mg/ml in Acetonitrile; (17?)-17-Hydroxyandrost-4-en-3-one; NCGC00258243-01; AC-14899; CPD000058344; SMR001261453; Testosterone, purum, >=99.0% (HPLC); Testosterone 100 microg/mL in Acetonitrile; BIM-0061761.0001; C00535; D00075; S00309; W-5033; AB00973630-03; Testosterone, VETRANAL(TM), analytical standard; 003T654; Androst-4-en-3-one, 17-hydroxy, (17.beta.)-; Q-101251; Q1318776; B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E; Testosterone, European Pharmacopoeia (EP) Reference Standard; Testosterone solution, 1.0 mg/mL in 1,2-dimethoxyethane, drug standard; Testosterone; 4-Androsten-17?-ol-3-one; 17?-Hydroxy-4-androsten-3-one; 1050678-68-6
Clinical Status
Approved
Disease Indication Osteoporosis ICD-11: FB83 [1]
PubChem CID
6013
Formula
C19H28O2
Canonical SMILES
C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2O)CCC4=CC(=O)CC[C@]34C
InChI
1S/C19H28O2/c1-18-9-7-13(20)11-12(18)3-4-14-15-5-6-17(21)19(15,2)10-8-16(14)18/h11,14-17,21H,3-10H2,1-2H3/t14-,15-,16-,17-,18-,19-/m0/s1
InChIKey
MUMGGOZAMZWBJJ-DYKIIFRCSA-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=6013"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 288.4 Topological Polar Surface Area 37.3
XlogP 3.3 Complexity 508
Heavy Atom Count 21 Rotatable Bond Count 0
Hydrogen Bond Donor Count 1 Hydrogen Bond Acceptor Count 2
Full List of Drug Formulations (DFMs) Containing This API
          Testosterone 30 mg film Click to Show/Hide the Full List of Formulation(s):          1 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
Anhydrous lactose; Lactose monohydrate; Magnesium stearate; Talc; Hypromellose; Silicon dioxide; Carbomer 934; Polycarbophil; Starch, corn
                   Dosage Form Buccal Film
                   Company Columbia Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Hypromellose DIG Info Cytochrome P450 3A5 (IC50 = 19.4 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
References
1 FDA label for approved testosterone from the official website of the U.S. Food and Drug Administration.
2 Mediation of in vitro cytochrome p450 activity by common pharmaceutical excipients. Mol Pharm. 2013 Jul 1;10(7):2739-48.
3 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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