Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00560)
Name
Progesterone
Synonyms    Click to Show/Hide the Synonyms of This API
progesterone; 57-83-0; Pregn-4-ene-3,20-dione; Agolutin; Luteohormone; Crinone; 4-Pregnene-3,20-dione; Corpus luteum hormone; Syngesterone; Utrogestan; Luteol; Glanducorpin; Pregnenedione; Progesterol; Syngestrets; Corlutin; Cyclogest; Gesterol; Gestone; Gestormone; Progestin; Progestone; Progestron; Prometrium; Hormoflaveine; Methylpregnone; Progestasert; Progesteronum; Progestronol; Corlutina; Corluvite; Corporin; Flavolutan; Fologenon; Gynlutin; Gynolutone; Hormoluton; Lingusorbs; Lucorteum; Luteodyn; Luteogan; Luteopur; Luteosan; Luteostab; Luteovis; Lutociclina; Lutocyclin; Lutocylin; Lutoform; Lutromone; Membrettes; Nalutron; Piaponon; Primolut; Progekan; Progestosol; Prolidon; Proluton; Protormone; Syntolutan; Gestron; Lutidon; Lutogyl; Lutren; Prolets; Luteal hormone; Lucorteum Sol; Bio-luton; Lutocyclin M; Lipo-Lutin; Luteocrin normale; Luteinique; Prochieve; Prolutone; 17alpha-Progesterone; Synovex S; Projestaject; Gynoluton; Gesterol 50; Percutacrine Luteinique; Gesterol 100; Cyclogesterin; Akrolutin; Prolutin; Pregnene-3,20-dione; (S)-Progesterone; Colprosterone; Endometrin; Progesteron; Progestogel; Progeston; 3,20-Pregnene-4; Gelbkoerperhormon; Crinone progesterone gel; Gestiron; Lugesteron; Progestol; Luteol (VAN); Lutocuclin M; .beta.-Progesterone; Percutacrine; (S)-4-Pregnene-3,20-dione; Progeffik; Utrogest; Vitarrine; Luteum; Progesteronum [INN-Latin]; Delta(4)-pregnene-3,20-dione; Progesterona [INN-Spanish]; (S)-Pregn-4-en-3,20-dione; NSC-9704; delta(sup 4)-Pregnene-3,20-dione; CCRIS 533; Prontogest; Estima; 17.alpha.-Progesterone; HSDB 3389; Progesterone [Progestins]; AI3-51682; Prometrium (TN); Pregn-4-en-3,20-dione; UNII-4G7DS2Q64Y; Crinone (TN); 6alpha-Methylpregn-4-en-17alpha-ol-3,20-dione; CHEBI:17026; .delta.4-Pregnene-3,20-dione; 17alpha-Hydroxy-6alpha-methylpregn-4-ene-3,20-dione; Pregn-4-ene-3,20-dione, 17alpha-hydroxy-6alpha-methyl-; component of Cyclogesterin; 4-Pregnen-3,20-dione; .delta.(sup4)-Pregnene-3,20-dione; CHEMBL103; D4-Pregnene-3,20-dione; MLS000028517; 4G7DS2Q64Y; NSC9704; NSC64377; MFCD00003658; NSC-64377; Progesterone, 98%; NCGC00015785-04; SMR000058345; DSSTox_CID_2370; U 3672; DSSTox_RID_76562; DSSTox_GSID_22370; 6.alpha.-Methylpregn-4-en-17.alpha.-ol-3,20-dione; 17.alpha.-Hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione; Progesterona; Progestan; Pregn-4-ene-3,20-dione, 17.alpha.-hydroxy-6.alpha.-methyl-; 753497-20-0; SMR000653542; Progesterone (Prometrium); WLN: L E5 B666 OV MUTJ A1 E1 FV1; SR-01000000088; SR-01000076054; NSC 9704; EINECS 200-350-6; NSC 64377; Pregn-4-ene-3, 17.alpha.-hydroxy-6.alpha.-methyl-; BHR-100; Duraprogen; Progestrel; Lipolutin; Lutinus; Lutogynon; delta4-Pregnene-3,20-dione; Progesterone??; beta-Progesterone; progesterone group; 17a-Progesterone; CAS-57-83-0; delta(Sup4)-pregnene-3,20-dione; Progesterone [USP:INN:BAN:JAN]; racemic progesterone; Prestwick_411; Progesterone solution; Opera_ID_292; Progesterone, >=99%; Prestwick0_000477; Prestwick1_000477; Prestwick2_000477; Prestwick3_000477; Spectrum5_002053; Cyclogesterin (Salt/Mix); bmse000482; Epitope ID:116051; EC 200-350-6; Pregn-4-ne-3,20-ione; SCHEMBL7671; BIDD:PXR0094; Lopac0_000895; BSPBio_000614; MLS000758277; MLS001074187; MLS001423982; MLS002222367; BIDD:ER0547; P0130_SIGMA; SPBio_002553; .delta.-Pregnene-3,20-dione; BDBM8903; BPBio1_000676; GTPL2377; Hydroxyprogesterone Caproic acid; DTXSID3022370; Progesterone (JP17/USP/INN); BHR-310; ETI-411; HMS1569O16; HMS2051O05; HMS2090J07; HMS2096O16; HMS2230F23; HMS2233P11; HMS3262D12; HMS3713O16; Pregnene, 3,20-dione-delta^4-; BCP22000; HY-N0437; ZINC4428529; Tox21_113157; Tox21_201792; Tox21_300307; Tox21_500895; AC-700; CMC_13406; LMST02030159; SBB012538; AKOS015894908; Progesterone; 4-Pregnene-3,20-dione; ACN-032010; CCG-100766; CS-1937; DB00396; DR-2011; EBD2157912; LP00895; NC00016; SDCCGSBI-0050870.P002; Progesterone 1.0 mg/ml in Acetonitrile; NCGC00022185-03; NCGC00022185-04; NCGC00022185-05; NCGC00022185-06; NCGC00022185-07; NCGC00022185-08; NCGC00022185-09; NCGC00022185-10; NCGC00022185-11; NCGC00022185-12; NCGC00022185-14; NCGC00022185-21; NCGC00090798-01; NCGC00090798-02; NCGC00254120-01; NCGC00259341-01; NCGC00261580-01; AS-12660; CPD000058345; NCI60_042166; ST069329; FE-999913; EU-0100895; (14beta,17alpha)-pregn-4-ene-3,20-dione; Progesterone, meets USP testing specifications; Progesterone, Vetec(TM) reagent grade, 98%; 6370-EP1441224A2; 6370-EP2269989A1; 6370-EP2269990A1; 6370-EP2275420A1; 6370-EP2284149A1; 6370-EP2289892A1; 6370-EP2292088A1; 6370-EP2292233A2; 6370-EP2292592A1; 6370-EP2295055A2; 6370-EP2295416A2; 6370-EP2298731A1; 6370-EP2298748A2; 6370-EP2298764A1; 6370-EP2298765A1; 6370-EP2298772A1; 6370-EP2305636A1; 6370-EP2305642A2; 6370-EP2308839A1; 6370-EP2308880A1; 6370-EP2311453A1; C00410; D00066; J10165; P 0130; Q26963; S00293; 10324-EP2295503A1; 10324-EP2301536A1; 10324-EP2301538A1; 10324-EP2311455A1; 10324-EP2316452A1; Progesterone, VETRANAL(TM), analytical standard; Q-201624; SR-01000000088-5; SR-01000000088-6; SR-01000076054-1; SR-01000076054-4; BRD-K64994968-001-03-6; 32104FB6-BF81-4F6E-83C2-024DEEAEB272; Progesterone, British Pharmacopoeia (BP) Reference Standard; Progesterone, powder, BioReagent, suitable for cell culture; Progesterone, European Pharmacopoeia (EP) Reference Standard; Progesterone, gamma-irradiated, BioXtra, suitable for cell culture; Progesterone, United States Pharmacopeia (USP) Reference Standard; Progesterone-Water Soluble, powder, BioReagent, suitable for cell culture; Progesterone, Pharmaceutical Secondary Standard; Certified Reference Material; 137940-28-4
Clinical Status
Approved
Disease Indication Endometrial hyperplasia ICD-11: GA16 [1]
PubChem CID
5994
Formula
C21H30O2
Canonical SMILES
CC(=O)[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)C
InChI
1S/C21H30O2/c1-13(22)17-6-7-18-16-5-4-14-12-15(23)8-10-20(14,2)19(16)9-11-21(17,18)3/h12,16-19H,4-11H2,1-3H3/t16-,17+,18-,19-,20-,21+/m0/s1
InChIKey
RJKFOVLPORLFTN-LEKSSAKUSA-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=5994"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 314.5 Topological Polar Surface Area 34.1
XlogP 3.9 Complexity 589
Heavy Atom Count 23 Rotatable Bond Count 1
Hydrogen Bond Donor Count 0 Hydrogen Bond Acceptor Count 2
Full List of Drug Formulations (DFMs) Containing This API
          Progesterone 100 mg capsule 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
D&c yellow no. 10; Fd&c red no. 40; Ammonia; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil; Shellac
                   Dosage Form Oral Capsule
                   Company Dr Reddy's 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]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c red no. 40; Ammonia; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Lecithin, soybean; Gelatin, unspecified; Peanut oil; Shellac
                   Dosage Form Oral Capsule
                   Company Golden State Medical Supply
                   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]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c yellow no. 6; Glycerin; Titanium dioxide; Water; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c red no. 40; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; PD-Rx 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]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c red no. 40; Glycerin; Titanium dioxide; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   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]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [3]
             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
Ferric oxide red; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Lecithin, soybean; Polyethylene glycol 400; Gelatin, unspecified; Peanut oil; Polyvinyl acetate phthalate
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
Polyethylene glycol 400 DIG Info Albendazole monooxygenase (IC50 = 10.77 mg.mL-1) [4]
             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
Ferric oxide red; Ferric oxide yellow; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company A-S Medication Solutions; AvKARE; Banner Life Sciences; Banner Pharmacaps; Bionpharma; Golden State Medical Supply; NuCare Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
Ferric oxide red; Ferric oxide yellow; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin, unspecified; Peanut oil
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
          Progesterone 200 mg capsule Click to Show/Hide the Full List of Formulation(s):          9 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
D&c yellow no. 10; Ammonia; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Lecithin, soybean; Gelatin, unspecified; Peanut oil; Shellac
                   Dosage Form Oral Capsule
                   Company Golden State Medical Supply
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Ammonia; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil; Shellac
                   Dosage Form Oral Capsule
                   Company Dr Reddy's Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c yellow no. 6; Glycerin; Titanium dioxide; Water; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c yellow no. 6; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin, unspecified; Peanut oil
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c yellow no. 6; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; PD-Rx Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             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
D&c yellow no. 10; Fd&c yellow no. 6; Glycerin; Titanium dioxide; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [3]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
             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
Ferric oxide yellow; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Lecithin, soybean; Polyethylene glycol 400; Gelatin, unspecified; Peanut oil; Polyvinyl acetate phthalate
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [4]
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
Polyethylene glycol 400 DIG Info Albendazole monooxygenase (IC50 = 10.77 mg.mL-1) [4]
             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
Ferric oxide red; Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company AvKARE; Banner Life Sciences; Banner Pharmacaps; Bionpharma; Golden State Medical Supply
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
             Drug Formulation 9 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
Glycerin; Titanium dioxide; Lecithin, soybean; Gelatin; Peanut oil
                   Dosage Form Oral Capsule
                   Company Akorn; AvKARE
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Soybean lecithin DIG Info Albendazole monooxygenase (IC50 = 6.61 mg.mL-1) [4]
References
1 FDA label for approved progesterone 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 Pharmaceutical excipients inhibit cytochrome P450 activity in cell free systems and after systemic administration. Eur J Pharm Biopharm. 2008 Sep;70(1):279-88.

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