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Chemistry

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Also known as: 202825-46-5, Safinamide mesilate, (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate, Pnu-151774e, Nw-1015, Safinamide (mesylate)
Molecular Formula
C18H23FN2O5S
Molecular Weight
398.5  g/mol
InChI Key
YKOCHIUQOBQIAC-YDALLXLXSA-N
FDA UNII
YS90V3DTX0

Safinamide Mesylate
1 2D Structure

Safinamide Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic acid
2.1.2 InChI
InChI=1S/C17H19FN2O2.CH4O3S/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14;1-5(2,3)4/h2-9,12,20H,10-11H2,1H3,(H2,19,21);1H3,(H,2,3,4)/t12-;/m0./s1
2.1.3 InChI Key
YKOCHIUQOBQIAC-YDALLXLXSA-N
2.1.4 Canonical SMILES
CC(C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
2.1.5 Isomeric SMILES
C[C@@H](C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
YS90V3DTX0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-2-((4-(3-fluorobenzoxy)benzyl)amino)propanamide

2. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide

3. Fbap Methanesulfonate

4. Fce 26743

5. Fce 28073

6. Fce-26743

7. Fce-28073

8. Nw-1015

9. Pnu 151774e

10. Pnu-151774e

11. Safinamide

12. Safinamide Methanesulfonate

13. Xadago

2.3.2 Depositor-Supplied Synonyms

1. 202825-46-5

2. Safinamide Mesilate

3. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide Methanesulfonate

4. Pnu-151774e

5. Nw-1015

6. Safinamide (mesylate)

7. Safinamide Methanesulfonate

8. Pnu 151774e

9. Safinamide Mesylate [usan]

10. Fce-28073

11. Nw 1015

12. Safinamide Methansulfonate

13. Ys90v3dtx0

14. Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2s)-, Methanesulfonate (1:1)

15. 202825-46-5 (mesylate)

16. Safinamide Mesilate (jan)

17. Safinamide Mesylate (usan)

18. Safinamide Mesilate [jan]

19. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)-amino)propanamide Methanesulfonate

20. Chembl48582

21. (s)-2-[[4-[(3-fluorobenzyl)oxy]benzyl]amino]propanamide Methanesulfonate

22. Unii-ys90v3dtx0

23. Fce-28073(r-isomer)

24. Safinamidemesylate

25. Equfina (tn)

26. Xadago (tn)

27. Safinamide Mesylate Salt

28. Emd 1195686 Mesylate

29. Mls006010740

30. Schembl1665715

31. Dtxsid80942414

32. Hms3884o17

33. Safinamide Mesylate (fce28073)

34. Amy38833

35. Bcp16018

36. Ex-a2640

37. Hy-70057a

38. Mfcd15145475

39. S1472

40. Safinamide Mesilate [who-dd]

41. Akos015902297

42. Ccg-268636

43. Safinamide Methanesulfonate [mi]

44. Safinamide Mesylate [orange Book]

45. Ac-27739

46. As-75602

47. Pnu-151774e,fce28073

48. Smr004701699

49. Safinamide Mesylate Salt, >=98% (hplc)

50. Cs-0006742

51. Sw219452-1

52. D10191

53. J-013174

54. Q27294690

55. (s)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate

56. (s)-(+)-2-(4-(3-fluorobenzyloxy) Benzylamino)propanamide, Methanesulfonate

57. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamidemethanesulfonate

58. (s)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate

59. (2s)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic Acid

60. Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (s)-, Monomethanesulfonate

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 398.5 g/mol
Molecular Formula C18H23FN2O5S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass398.13117117 g/mol
Monoisotopic Mass398.13117117 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count27
Formal Charge0
Complexity438
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Xadago is indicated for the treatment of adult patients with idiopathic Parkinsons disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Monoamine Oxidase Type B Inhibitor [EPC]; Monoamine Oxidase-B Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
5.2 ATC Code

N04B


API Reference Price

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11-Feb-2021
19-Dec-2024
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FDF Dossiers

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01

German Catalysts Meet
Not Confirmed
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German Catalysts Meet
Not Confirmed

SAFINAMIDE MESYLATE

Brand Name : XADAGO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2017-03-21

Application Number : 207145

Regulatory Info : RX

Registration Country : USA

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02

German Catalysts Meet
Not Confirmed
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arrow
German Catalysts Meet
Not Confirmed

SAFINAMIDE MESYLATE

Brand Name : SAFINAMIDE MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2024-12-31

Application Number : 215978

Regulatory Info : RX

Registration Country : USA

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03

Prinston

U.S.A
German Catalysts Meet
Not Confirmed
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Prinston

U.S.A
arrow
German Catalysts Meet
Not Confirmed

SAFINAMIDE MESYLATE

Brand Name : SAFINAMIDE MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2024-04-25

Application Number : 215739

Regulatory Info : RX

Registration Country : USA

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04

RK Pharma

U.S.A
German Catalysts Meet
Not Confirmed
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RK Pharma

U.S.A
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German Catalysts Meet
Not Confirmed

SAFINAMIDE

Brand Name : SAFINAMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 215945

Regulatory Info :

Registration Country : USA

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05

Seqirus

Australia
German Catalysts Meet
Not Confirmed
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Seqirus

Australia
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German Catalysts Meet
Not Confirmed

safinamide

Brand Name : Xadago

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Seqirus

Australia
German Catalysts Meet
Not Confirmed
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Seqirus

Australia
arrow
German Catalysts Meet
Not Confirmed

safinamide

Brand Name : Xadago

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Zambon Switzerland

Switzerland
German Catalysts Meet
Not Confirmed
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Zambon Switzerland

Switzerland
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German Catalysts Meet
Not Confirmed

safinamidmesilat

Brand Name : Xadago

Dosage Form : FILM COATED PILL

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Zambon Switzerland

Switzerland
German Catalysts Meet
Not Confirmed
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Zambon Switzerland

Switzerland
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German Catalysts Meet
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Safinamide 100Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Zambon Switzerland

Switzerland
German Catalysts Meet
Not Confirmed
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Zambon Switzerland

Switzerland
arrow
German Catalysts Meet
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

Zambon Switzerland

Switzerland
German Catalysts Meet
Not Confirmed
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Zambon Switzerland

Switzerland
arrow
German Catalysts Meet
Not Confirmed

Safinamide

Brand Name : Xadago

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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DOSAGE - TABLET;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 207145

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DOSAGE - TABLET;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 207145

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PharmaCompass offers a list of Safinamide Mesylate 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 Safinamide Mesylate manufacturer or Safinamide Mesylate supplier for your needs.

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

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

API | Excipient name

Safinamide Mesylate

Synonyms

202825-46-5, Safinamide mesilate, (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate, Pnu-151774e, Nw-1015, Safinamide (mesylate)

Cas Number

202825-46-5

Unique Ingredient Identifier (UNII)

YS90V3DTX0

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Manufacturers

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide, including repackagers and relabelers. The FDA regulates 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Suppliers

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide supplier is an individual or a company that provides 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide finished formulations upon request. The 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers may include 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide API manufacturers, exporters, distributors and traders.

click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) in detail. Different forms of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMFs exist exist since differing nations have different regulations, such as 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide DMF submitted to regulatory agencies in the US is known as a USDMF. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF includes data on 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with USDMF on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Drug Master File in Japan (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JDMF) empowers 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JDMF during the approval evaluation for pharmaceutical products. At the time of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with JDMF on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide Drug Master File in Korea (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide. The MFDS reviews the 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF as part of the drug registration process and uses the information provided in the 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF to evaluate the safety and efficacy of the drug.

After submitting a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with KDMF on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide written confirmation (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC) is an official document issued by a regulatory agency to a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide manufacturer, verifying that the manufacturing facility of a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide APIs or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide WC (written confirmation) as part of the regulatory process.

click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with Written Confirmation (WC) on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide suppliers with NDC on PharmaCompass.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide GMP

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide GMP manufacturer or 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide GMP API supplier for your needs.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA

A 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA (Certificate of Analysis) is a formal document that attests to 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide's compliance with 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide specifications and serves as a tool for batch-level quality control.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide CoA mostly includes findings from lab analyses of a specific batch. For each 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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.

2-(4-(3-fluorobenzyloxy)benzylamino)propionamide may be tested according to a variety of international standards, such as European Pharmacopoeia (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide EP), 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-(4-(3-fluorobenzyloxy)benzylamino)propionamide 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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