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    Also known as: 461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin
    Molecular Formula
    C21H25ClO6
    Molecular Weight
    408.9  g/mol
    InChI Key
    JVHXJTBJCFBINQ-ADAARDCZSA-N
    FDA UNII
    1ULL0QJ8UC
    Dapagliflozin
    Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.
    Dapagliflozin is a Sodium-Glucose Cotransporter 2 Inhibitor. The mechanism of action of dapagliflozin is as a Sodium-Glucose Transporter 2 Inhibitor.
    1 2D Structure

    Dapagliflozin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
    2.1.2 InChI
    InChI=1S/C21H25ClO6/c1-2-27-15-6-3-12(4-7-15)9-14-10-13(5-8-16(14)22)21-20(26)19(25)18(24)17(11-23)28-21/h3-8,10,17-21,23-26H,2,9,11H2,1H3/t17-,18-,19+,20-,21+/m1/s1
    2.1.3 InChI Key
    JVHXJTBJCFBINQ-ADAARDCZSA-N
    2.1.4 Canonical SMILES
    CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl
    2.1.5 Isomeric SMILES
    CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)CO)O)O)O)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    1ULL0QJ8UC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

    2. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol

    3. Bms 512148

    4. Bms-512148

    5. Bms512148

    6. Farxiga

    7. Forxiga

    2.3.2 Depositor-Supplied Synonyms

    1. 461432-26-8

    2. Bms-512148

    3. Forxiga

    4. Bms 512148

    5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

    6. Dagagflozin

    7. (1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol

    8. 1ull0qj8uc

    9. Chembl429910

    10. Chebi:85078

    11. Lyn-045

    12. Dapagliflozin [usan:inn]

    13. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

    14. (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol

    15. Bms512148

    16. Forxiga (tn)

    17. Chembl3125458

    18. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-

    19. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

    20. Dapagliflozin [usan]

    21. Unii-1ull0qj8uc

    22. Bms5121458

    23. S1548_selleck

    24. C-aryl Glucoside, 6

    25. Dapagliflozin [mi]

    26. Dapagliflozin [inn]

    27. Dapagliflozin (usan/inn)

    28. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol

    29. Dapagliflozin [vandf]

    30. Schembl157820

    31. Dapagliflozin [who-dd]

    32. Gtpl4594

    33. Bdbm20880

    34. Dtxsid20905104

    35. Ex-a005

    36. Bcpp000265

    37. Dapagliflozin [orange Book]

    38. Amy18541

    39. Zinc3819138

    40. Bdbm50448923

    41. Mfcd13182359

    42. S1548

    43. Qternmet Component Dapaglifozin

    44. Akos005145763

    45. Dapagliflozin Component Qternmet

    46. Bcp9000583

    47. Bl-0052

    48. Ccg-229917

    49. Cs-0781

    50. Db06292

    51. Ex-7214

    52. Ncgc00250402-09

    53. Ac-24699

    54. Bd164346

    55. Hy-10450

    56. Qternmet Xr Component Dapagliflozin

    57. Dapagliflozin Component Of Qternmet Xr

    58. A25150

    59. C22193

    60. D08897

    61. 432d268

    62. Q409898

    63. J-500392

    64. Brd-k58160573-001-01-3

    65. Brd-k58160573-001-05-4

    66. 1-[3-(beta-d-glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene

    67. (1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol

    68. (2s, 3r, 4r, 5s, 6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol

    69. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol

    70. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol;bms-512148

    71. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 408.9 g/mol
    Molecular Formula C21H25ClO6
    XLogP32.3
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count6
    Exact Mass408.1339662 g/mol
    Monoisotopic Mass408.1339662 g/mol
    Topological Polar Surface Area99.4 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity472
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    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 NameFarxiga
    PubMed HealthDapagliflozin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelDapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig...
    Active IngredientDapagliflozin
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusPrescription
    CompanyAstrazeneca Ab

    2 of 2  
    Drug NameFarxiga
    PubMed HealthDapagliflozin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelDapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig...
    Active IngredientDapagliflozin
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg
    Market StatusPrescription
    CompanyAstrazeneca Ab

    4.2 Drug Indication

    Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.

    FDA Label

    Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

    - as monotherapy when metformin is considered inappropriate due to intolerance.

    - in addition to other medicinal products for the treatment of type 2 diabetes.

    For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied.

    Heart failure

    - Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

    Chronic kidney disease

    - Forxiga is indicated in adults for the treatment of chronic kidney disease.

    Type 2 diabetes mellitus

    Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

    - as monotherapy when metformin is considered inappropriate due to intolerance.

    - in addition to other medicinal products for the treatment of type 2 diabetes.

    For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

    Heart failure

    Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

    Chronic kidney disease

    Edistride is indicated in adults for the treatment of chronic kidney disease.

    Treatment of chronic kidney disease

    Prevention of cardiovascular events in patients with chronic heart failure

    Treatment of type I diabetes mellitus

    Treatment of type II diabetes mellitus

    Treatment of ischaemic heart disease

    Treatment of Coronavirus disease 2019 (COVID-19)

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.

    5.2 MeSH Pharmacological Classification

    Sodium-Glucose Transporter 2 Inhibitors

    Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DAPAGLIFLOZIN
    5.3.2 FDA UNII
    1ULL0QJ8UC
    5.3.3 Pharmacological Classes
    Sodium-Glucose Transporter 2 Inhibitors [MoA]; Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    5.4 ATC Code

    A10BK01

    A10BK01

    A10BK01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors

    A10BK01 - Dapagliflozin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral dapagliflozin reaches a maximum concentration within 1 hour of administration when patients have been fasting. When patients have consumed a high fat meal, the time to maximum concentration increases to 2 hours and the maximum concentration decreases by half though a dose adjustment is not necessary. Oral dapagliflozin is 78% bioavailable.

    Route of Elimination

    75.2% of dapagliflozin is recovered in the urine with 1.6% of the dose unchanged by metabolism. 21% of the dose is excreted in the feces with 15% of the dose unchanged by metabolism.

    Volume of Distribution

    118L.

    Clearance

    Oral plasma clearance was 4.9 mL/min/kg, and renal clearance was 5.6 mL/min.

    5.6 Metabolism/Metabolites

    Dapagliflozin is primarily glucuronidated to become the inactive 3-O-glucuronide metabolite(60.7%). Dapagliflozin also produces another minor glucuronidated metabolite(5.4%), a de-ethylated metabolite(<5%), and a hydroxylated metabolite(<5%). Metabolism of dapagliflozin is mediated by cytochrome p-450(CYP)1A1, CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP3A4, uridine diphosphate glucuronyltransferase(UGT)1A9, UGT2B4, and UGT2B7. Glucuronidation to the major metabolite is mediated by UGT1A9.

    5.7 Biological Half-Life

    13.8h.

    5.8 Mechanism of Action

    Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.

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    11-Jan-2022
    29-Dec-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 202293

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 202293

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    ABOUT THIS PAGE

    Looking for 461432-26-8 / Dapagliflozin API manufacturers, exporters & distributors?

    Dapagliflozin manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Dapagliflozin

    Synonyms

    461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin

    Cas Number

    461432-26-8

    Unique Ingredient Identifier (UNII)

    1ULL0QJ8UC

    About Dapagliflozin

    Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.

    Farxiga Manufacturers

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

    Farxiga Suppliers

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

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

    Farxiga USDMF

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

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

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

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

    Farxiga KDMF

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

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

    After submitting a Farxiga 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 Farxiga API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Farxiga suppliers with KDMF on PharmaCompass.

    Farxiga CEP

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

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

    Farxiga WC

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

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

    Farxiga 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 Farxiga as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Farxiga GMP

    Farxiga 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 Farxiga 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 Farxiga GMP manufacturer or Farxiga GMP API supplier for your needs.

    Farxiga CoA

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

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

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