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Chemistry

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Also known as: Valbenazine ditosylate, 1639208-54-0, Valbenazine tosilate, Valbenazine (tosylate), Nbi-98854 ditosylate, Valbenazine tosylate [usan]
Molecular Formula
C38H54N2O10S2
Molecular Weight
763.0  g/mol
InChI Key
BXGKAGLZHGYAMW-TZYFFPFWSA-N
FDA UNII
5SML1T733B

Valbenazine Tosylate
1 2D Structure

Valbenazine Tosylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R,3R,11bR)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1H-benzo[a]quinolizin-2-yl] (2S)-2-amino-3-methylbutanoate;4-methylbenzenesulfonic acid
2.1.2 InChI
InChI=1S/C24H38N2O4.2C7H8O3S/c1-14(2)9-17-13-26-8-7-16-10-21(28-5)22(29-6)11-18(16)19(26)12-20(17)30-24(27)23(25)15(3)4;2*1-6-2-4-7(5-3-6)11(8,9)10/h10-11,14-15,17,19-20,23H,7-9,12-13,25H2,1-6H3;2*2-5H,1H3,(H,8,9,10)/t17-,19-,20-,23+;;/m1../s1
2.1.3 InChI Key
BXGKAGLZHGYAMW-TZYFFPFWSA-N
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC(C)CC1CN2CCC3=CC(=C(C=C3C2CC1OC(=O)C(C(C)C)N)OC)OC
2.1.5 Isomeric SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC(C)C[C@@H]1CN2CCC3=CC(=C(C=C3[C@H]2C[C@H]1OC(=O)[C@H](C(C)C)N)OC)OC
2.2 Other Identifiers
2.2.1 UNII
5SML1T733B
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Valbenazine Ditosylate

2. 1639208-54-0

3. Valbenazine Tosilate

4. Valbenazine (tosylate)

5. Nbi-98854 Ditosylate

6. Valbenazine Tosylate [usan]

7. 5sml1t733b

8. 1639208-54-0 (tosylayte)

9. Valbenazine Tosilate (jan)

10. Valbenazine Tosylate (usan)

11. Valbenazine Tosilate [jan]

12. (2r,3r,11br)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2h-pyrido[2,1-a]isoquinolin-2-yl L-valinate Di(4-methylbenzenesulfonate)

13. L-valine, (2r,3r,11br)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2h-benzo(a)quinolizin-2-yl Ester, 4-methylbenzenesulfonate (1:2)

14. Ingrezza (tn)

15. Nbi-98854 Tosylate

16. Unii-5sml1t733b

17. Valbenazine Tosylate (1:2)

18. Chembl3707248

19. Schembl18863051

20. Valbenazine Tosylate [mi]

21. Dtxsid201026308

22. Hy-16771a

23. S9500

24. Valbenazine Tosilate [who-dd]

25. Ccg-270445

26. Valbenazine Tosylate [orange Book]

27. Cs-0030913

28. D10999

29. Q27262815

30. (2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2h-benzo(a)quinolizin-2-yl L-valinate Bis(4-methylbenzenesulfonate)

31. [(2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1h-benzo[a]quinolizin-2-yl] (2s)-2-amino-3-methylbutanoate;4-methylbenzenesulfonic Acid

2.4 Create Date
2015-11-09
3 Chemical and Physical Properties
Molecular Weight 763.0 g/mol
Molecular Formula C38H54N2O10S2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count12
Rotatable Bond Count10
Exact Mass762.32198827 g/mol
Monoisotopic Mass762.32198827 g/mol
Topological Polar Surface Area200 Ų
Heavy Atom Count52
Formal Charge0
Complexity776
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameINGREZZA
Active IngredientVALBENAZINE TOSYLATE
CompanyNEUROCRINE (Application Number: N209241. Patents: 8039627, 8357697)

API Reference Price

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23-Jan-2023
28-Feb-2024
KGS
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Looking for 1639208-54-0 / Valbenazine Tosylate API manufacturers, exporters & distributors?

Valbenazine Tosylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Valbenazine Tosylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier.

PharmaCompass also assists you with knowing the Valbenazine Tosylate API Price utilized in the formulation of products. Valbenazine Tosylate API Price is not always fixed or binding as the Valbenazine Tosylate Price is obtained through a variety of data sources. The Valbenazine Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Valbenazine Tosylate

Synonyms

Valbenazine ditosylate, 1639208-54-0, Valbenazine tosilate, Valbenazine (tosylate), Nbi-98854 ditosylate, Valbenazine tosylate [usan]

Cas Number

1639208-54-0

Unique Ingredient Identifier (UNII)

5SML1T733B

Valbenazine Ditosylate Manufacturers

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

Valbenazine Ditosylate Suppliers

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

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

Valbenazine Ditosylate USDMF

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

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

click here to find a list of Valbenazine Ditosylate suppliers with USDMF on PharmaCompass.

Valbenazine Ditosylate WC

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

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

Valbenazine Ditosylate 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 Valbenazine Ditosylate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Valbenazine Ditosylate 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 Valbenazine Ditosylate 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 Valbenazine Ditosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valbenazine Ditosylate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Valbenazine Ditosylate suppliers with NDC on PharmaCompass.

Valbenazine Ditosylate GMP

Valbenazine Ditosylate 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 Valbenazine Ditosylate 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 Valbenazine Ditosylate GMP manufacturer or Valbenazine Ditosylate GMP API supplier for your needs.

Valbenazine Ditosylate CoA

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

Valbenazine Ditosylate CoA mostly includes findings from lab analyses of a specific batch. For each Valbenazine Ditosylate 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.

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