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    Also known as: 960404-48-2, Dapagliflozin propanediol monohydrate, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05
    Molecular Formula
    C24H35ClO9
    Molecular Weight
    503.0  g/mol
    InChI Key
    GOADIQFWSVMMRJ-UPGAGZFNSA-N
    FDA UNII
    887K2391VH
    Dapagliflozin Propanediol Monohydrate
    Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.
    1 2D Structure

    Dapagliflozin Propanediol Monohydrate

    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;(2S)-propane-1,2-diol;hydrate
    2.1.2 InChI
    InChI=1S/C21H25ClO6.C3H8O2.H2O/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;1-3(5)2-4;/h3-8,10,17-21,23-26H,2,9,11H2,1H3;3-5H,2H2,1H3;1H2/t17-,18-,19+,20-,21+;3-;/m10./s1
    2.1.3 InChI Key
    GOADIQFWSVMMRJ-UPGAGZFNSA-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.CC(CO)O.O
    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.C[C@@H](CO)O.O
    2.2 Other Identifiers
    2.2.1 UNII
    887K2391VH
    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. Dapagliflozin

    7. Farxiga

    8. Forxiga

    2.3.2 Depositor-Supplied Synonyms

    1. 960404-48-2

    2. Dapagliflozin Propanediol Monohydrate

    3. Dapagliflozin Propanediol Hydrate

    4. Farxiga

    5. Dapagliflozin ((2s)-1,2-propanediol, Hydrate)

    6. Bms-512148-05

    7. Dapagliflozin S-propylene Glycol Monohydrate

    8. Dapagliflozin Propylene Glycolate Hydrate

    9. Chebi:85079

    10. Dapagliflozin Propanediol [usan]

    11. Dapagliflozin Mixture With Propylene Glycol, Hydrate

    12. 887k2391vh

    13. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol;(2s)-propane-1,2-diol;hydrate

    14. Dapagliflozin [usan:inn]

    15. Dapagliflozin Propylene Glycol Hydrate

    16. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol Compound With (s)-propane-1,2-diol (1:1) Hydrate

    17. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-, Compd. With (2s)-1,2-propanediol, Hydrate (1:1:1)

    18. Unii-887k2391vh

    19. Dapagliflozin Propylene Glycolate Hydrate [jan]

    20. Dapagliflozin (s)-propylene Glycol Hydrate

    21. Chembl2103802

    22. Dtxsid00914678

    23. Ex-a2824

    24. Dapagliflozin Propylene Glycol

    25. Hy-10450a

    26. Mfcd28167768

    27. S5566

    28. Akos027250601

    29. Ccg-269711

    30. Ac-29230

    31. As-64915

    32. Dapagliflozin (2s)-1,2-propanediol Hydrate

    33. F20667

    34. Bms-512148 (2s)-1,2-propanediol, Hydrate

    35. Dapagliflozin (2s)-1,2-propanediol Monohydrate

    36. Xigduo Component Dapagliflozin Propanediol

    37. A900162

    38. Dapagliflozin Propanediol Component Of Xigduo

    39. Dapagliflozin Propanediol Monohydrate [who-dd]

    40. Q27158320

    41. Dapagliflozin Propanediol Monohydrate [ema Epar]

    42. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate

    43. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate [mi]

    44. (2s)-propane-1,2-diol (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol Hydrate

    45. (2s)-propane-1,2-diol--(1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol--water (1/1/1)

    46. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro- 2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

    47. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol (s)-propane-1,2-diol Hydrate

    48. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

    49. 1700615-13-9

    2.4 Create Date
    2008-09-29
    3 Chemical and Physical Properties
    Molecular Weight 503.0 g/mol
    Molecular Formula C24H35ClO9
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count7
    Exact Mass502.1969604 g/mol
    Monoisotopic Mass502.1969604 g/mol
    Topological Polar Surface Area141 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity493
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Indication

    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.

    5 Pharmacology and Biochemistry
    5.1 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.)

    5.2 ATC Code

    A10BK01

    A10BK01

    API Reference Price

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    10-Jan-2022
    22-Jan-2026
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    ABOUT THIS PAGE

    Looking for 1700615-13-9 / Dapagliflozin Propanediol Monohydrate API manufacturers, exporters & distributors?

    Dapagliflozin Propanediol Monohydrate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Dapagliflozin Propanediol Monohydrate

    Synonyms

    960404-48-2, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05, Dapagliflozin s-propylene glycol monohydrate

    Cas Number

    1700615-13-9

    Unique Ingredient Identifier (UNII)

    887K2391VH

    About Dapagliflozin Propanediol Monohydrate

    Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.

    dapagliflozin (S)-propylene glycol hydrate Manufacturers

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

    dapagliflozin (S)-propylene glycol hydrate Suppliers

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate USDMF

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

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate KDMF

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

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

    After submitting a dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with KDMF on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate CEP

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

    A dapagliflozin (S)-propylene glycol hydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate suppliers with CEP (COS) on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate WC

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with Written Confirmation (WC) on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a dapagliflozin (S)-propylene glycol hydrate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with NDC on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate GMP

    dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate GMP manufacturer or dapagliflozin (S)-propylene glycol hydrate GMP API supplier for your needs.

    dapagliflozin (S)-propylene glycol hydrate CoA

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

    dapagliflozin (S)-propylene glycol hydrate CoA mostly includes findings from lab analyses of a specific batch. For each dapagliflozin (S)-propylene glycol hydrate 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.

    dapagliflozin (S)-propylene glycol hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (dapagliflozin (S)-propylene glycol hydrate EP), dapagliflozin (S)-propylene glycol hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (dapagliflozin (S)-propylene glycol hydrate 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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