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Chemistry

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Also known as: 5002-47-1, Modecate, Fluphenazine depot, Moditen depot, Dapotum d, Lyogen
Molecular Formula
C32H44F3N3O2S
Molecular Weight
591.8  g/mol
InChI Key
VIQCGTZFEYDQMR-UHFFFAOYSA-N
FDA UNII
FMU62K1L3C

Fluphenazine Decanoate
Fluphenazine Decanoate is the decanoate salt form of fluphenazine, a phenothiazine with antipsychotic activity. Fluphenazine decanoate exerts its actions by blocking postsynaptic dopamine D2 receptors in the limbic, cortical system and basal ganglia. This prevents the actions of dopamine, thereby reducing the hallucinations and delusions that are associated with schizophrenia.
1 2D Structure

Fluphenazine Decanoate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl decanoate
2.1.2 InChI
InChI=1S/C32H44F3N3O2S/c1-2-3-4-5-6-7-8-14-31(39)40-24-23-37-21-19-36(20-22-37)17-11-18-38-27-12-9-10-13-29(27)41-30-16-15-26(25-28(30)38)32(33,34)35/h9-10,12-13,15-16,25H,2-8,11,14,17-24H2,1H3
2.1.3 InChI Key
VIQCGTZFEYDQMR-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCCCCCCC(=O)OCCN1CCN(CC1)CCCN2C3=CC=CC=C3SC4=C2C=C(C=C4)C(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
FMU62K1L3C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fluphenazine Depot

2. Ftorphenazine Decanoate

3. Liogen

4. Mirenil

5. Modecate

6. Moditen Depot

7. Moditen-depot

2.3.2 Depositor-Supplied Synonyms

1. 5002-47-1

2. Modecate

3. Fluphenazine Depot

4. Moditen Depot

5. Dapotum D

6. Lyogen

7. Prolixin Decanoate

8. Flufenazine Decanoate

9. Fluorophenazine Decanoate

10. Fluphenazine O-decanoate

11. Fluphenaline Decanoate

12. Sq 10,733

13. 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl Decanoate

14. 2-(4-{3-[2-(trifluoromethyl)-10h-phenothiazin-10-yl]propyl}piperazin-1-yl)ethyl Decanoate

15. Nsc-169510

16. Fmu62k1l3c

17. 2-(4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl Decanoate

18. Decanoic Acid, 2-(4-(3-(2-(trifluoromethyl)-10h-phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl Ester

19. Decanoic Acid, 2-[4-[3-[2-(trifluoromethyl)-10h-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl Ester

20. Qd-10733

21. Sq-10733

22. 2-(4-(3-(2-(trifluoromethyl)-10h-phenothiazin-10-yl)propyl)piperazin-1-yl)ethyl Decanoate

23. Decanoic Acid, 2-(4-(3-(2-(trifluoromethyl)phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl Ester

24. Decanoic Acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl Ester

25. Moditen-depo

26. Fluphenazinedecanoate

27. Ccris 3954

28. Prolixin Decanoate (tn)

29. Einecs 225-672-4

30. Unii-fmu62k1l3c

31. Nsc 169510

32. Brn 0599852

33. Dapotum Depot

34. Fluphenazine Decanoate (jan/usp)

35. Anatensol Decanoate

36. Fluphenazini Decanoas

37. Depot

38. Fluphenazine-decanoate

39. Fluphenazine Decanoate [usp:ban:jan]

40. Schembl41288

41. Mls006010097

42. Chebi:5124

43. Chembl1200854

44. Dtxsid7023069

45. Fluphenazine Decanoate [mi]

46. Bcp18078

47. Hy-b1904

48. Fluphenazine Decanoate [jan]

49. Mfcd00798504

50. Nsc169510

51. Zinc22816725

52. Fluphenazine Decanoate [vandf]

53. Akos003589045

54. Fluphenazine Decanoate [mart.]

55. Fluphenazine Decanoate [who-dd]

56. Fluphenazine Decanoate [who-ip]

57. Ncgc00386699-01

58. As-11646

59. Smr004701239

60. Fluphenazine Decanoate [orange Book]

61. Cs-0013962

62. Fluphenazine Decanoate [ep Monograph]

63. Fluphenazine Decanoate [usp Impurity]

64. Fluphenazini Decanoas [who-ip Latin]

65. Fluphenazine Decanoate [usp Monograph]

66. C07956

67. D00793

68. 002f471

69. A827938

70. Fluphenazine Enanthate Impurity C [ep Impurity]

71. Q27278080

72. Wln: T C666 Bn Isj Exfff B3- At6n Dntj D2ov9

73. Decanoic Acid, 2-(4-(3-(2-(trifluoromethyl)-10h-decanoate Phenothiazin-10-yl)propyl)-1-piperazinyl)ethyl Ester

74. Decanoic Acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl Ester (7ci,8ci)

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 591.8 g/mol
Molecular Formula C32H44F3N3O2S
XLogP39
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count9
Rotatable Bond Count16
Exact Mass591.31063331 g/mol
Monoisotopic Mass591.31063331 g/mol
Topological Polar Surface Area61.3 Ų
Heavy Atom Count41
Formal Charge0
Complexity765
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFluphenazine decanoate
Drug LabelFluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect and has the following structural formula:Fluphenazine Decanoate Injection...
Active IngredientFluphenazine decanoate
Dosage FormInjectable
RouteInjection
Strength25mg/ml
Market StatusPrescription
CompanyPar Sterile Products; Fresenius Kabi Usa; Eurohlth Intl

2 of 2  
Drug NameFluphenazine decanoate
Drug LabelFluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect and has the following structural formula:Fluphenazine Decanoate Injection...
Active IngredientFluphenazine decanoate
Dosage FormInjectable
RouteInjection
Strength25mg/ml
Market StatusPrescription
CompanyPar Sterile Products; Fresenius Kabi Usa; Eurohlth Intl

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antipsychotic Agents

Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Phenothiazines [CS]; Phenothiazine [EPC]

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ABOUT THIS PAGE

Fluphenazine Decanoate Manufacturers

A Fluphenazine Decanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluphenazine Decanoate, including repackagers and relabelers. The FDA regulates Fluphenazine Decanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluphenazine Decanoate 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 Fluphenazine Decanoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Fluphenazine Decanoate Suppliers

A Fluphenazine Decanoate supplier is an individual or a company that provides Fluphenazine Decanoate active pharmaceutical ingredient (API) or Fluphenazine Decanoate finished formulations upon request. The Fluphenazine Decanoate suppliers may include Fluphenazine Decanoate API manufacturers, exporters, distributors and traders.

click here to find a list of Fluphenazine Decanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fluphenazine Decanoate USDMF

A Fluphenazine Decanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluphenazine Decanoate active pharmaceutical ingredient (API) in detail. Different forms of Fluphenazine Decanoate DMFs exist exist since differing nations have different regulations, such as Fluphenazine Decanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Fluphenazine Decanoate DMF submitted to regulatory agencies in the US is known as a USDMF. Fluphenazine Decanoate USDMF includes data on Fluphenazine Decanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluphenazine Decanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Fluphenazine Decanoate suppliers with USDMF on PharmaCompass.

Fluphenazine Decanoate JDMF

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 Fluphenazine Decanoate Drug Master File in Japan (Fluphenazine Decanoate JDMF) empowers Fluphenazine Decanoate 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 Fluphenazine Decanoate JDMF during the approval evaluation for pharmaceutical products. At the time of Fluphenazine Decanoate 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 Fluphenazine Decanoate suppliers with JDMF on PharmaCompass.

Fluphenazine Decanoate CEP

A Fluphenazine Decanoate CEP of the European Pharmacopoeia monograph is often referred to as a Fluphenazine Decanoate Certificate of Suitability (COS). The purpose of a Fluphenazine Decanoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluphenazine Decanoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluphenazine Decanoate to their clients by showing that a Fluphenazine Decanoate CEP has been issued for it. The manufacturer submits a Fluphenazine Decanoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluphenazine Decanoate CEP holder for the record. Additionally, the data presented in the Fluphenazine Decanoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluphenazine Decanoate DMF.

A Fluphenazine Decanoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluphenazine Decanoate 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 Fluphenazine Decanoate suppliers with CEP (COS) on PharmaCompass.

Fluphenazine Decanoate WC

A Fluphenazine Decanoate written confirmation (Fluphenazine Decanoate WC) is an official document issued by a regulatory agency to a Fluphenazine Decanoate manufacturer, verifying that the manufacturing facility of a Fluphenazine Decanoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fluphenazine Decanoate APIs or Fluphenazine Decanoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fluphenazine Decanoate WC (written confirmation) as part of the regulatory process.

click here to find a list of Fluphenazine Decanoate suppliers with Written Confirmation (WC) on PharmaCompass.

Fluphenazine Decanoate NDC

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 Fluphenazine Decanoate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fluphenazine Decanoate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Fluphenazine Decanoate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fluphenazine Decanoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluphenazine Decanoate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fluphenazine Decanoate suppliers with NDC on PharmaCompass.

Fluphenazine Decanoate GMP

Fluphenazine Decanoate 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 Fluphenazine Decanoate 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 Fluphenazine Decanoate GMP manufacturer or Fluphenazine Decanoate GMP API supplier for your needs.

Fluphenazine Decanoate CoA

A Fluphenazine Decanoate CoA (Certificate of Analysis) is a formal document that attests to Fluphenazine Decanoate's compliance with Fluphenazine Decanoate specifications and serves as a tool for batch-level quality control.

Fluphenazine Decanoate CoA mostly includes findings from lab analyses of a specific batch. For each Fluphenazine Decanoate 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.

Fluphenazine Decanoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluphenazine Decanoate EP), Fluphenazine Decanoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluphenazine Decanoate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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