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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

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BRNIK","customer":"LAURUS LABS LTD","customerCountry":"INDIA","quantity":"1.49","actualQuantity":"1.488","unit":"KGS","unitRateFc":"3681.2","totalValueFC":"5536.8","currency":"USD","unitRateINR":"314008.3","date":"21-Nov-2024","totalValueINR":"467244.4","totalValueInUsd":"5536.8","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"6798339","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"SMARJESKA CESTA 6 NOVO MESTO 8501 S I SDNF Slovenia","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"(FOC) DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE API (5 G POWDERIN CLEAR PLASTIC CONTAINER WITH RED CAP)","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL WORKS LTD","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"2","totalValueFC":"12.1","currency":"USD","unitRateINR":"204.8","date":"05-Dec-2024","totalValueINR":"1024.2","totalValueInUsd":"12.1","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"7070025","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"BUDAPEST,","supplierAddress":"Eniko Hajzer, Generic R&D, 13 Palla gi street Debrecen H-4042 ., , Hung ary Hungary","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739903400,"product":"(FOC) DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE API BATCH NUMBER: D5551-23-005(FOC) DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE API BATCH NUMBER","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL WORKS LTD","supplierCountry":"HUNGARY","foreign_port":"DEBRECEN","customer":"WATSON PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"2.4","totalValueFC":"12.2","currency":"USD","unitRateINR":"212.2","date":"19-Feb-2025","totalValueINR":"1060.8","totalValueInUsd":"12.2","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"8452350","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"DEBRECEN","supplierAddress":"Eniko Hajzer, Generic R&D, 13 Palla gi street Debrecen H-4042 Hungary SDNF Hungary","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741804200,"product":"DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE","address":"NO.18, BANASAWADI-RAMAMURTHY NAGAR","city":"BANGALORE, KARNATAKA","supplier":"HONOUR LABS LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"BLUEFISH PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"1757.6","totalValueFC":"2672.3","currency":"USD","unitRateINR":"154314","date":"13-Mar-2025","totalValueINR":"231471","totalValueInUsd":"2672.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29329990","bill_no":"8855494","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 4 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM VILLAGE, NAKKAPALLY M SDNF India","customerAddress":"NO.18, BANASAWADI-RAMAMURTHY NAGAR"}]
    11-Jan-2022
    28-Feb-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

    42

    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.

    BMS-512148-05 Manufacturers

    A BMS-512148-05 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BMS-512148-05, including repackagers and relabelers. The FDA regulates BMS-512148-05 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BMS-512148-05 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 BMS-512148-05 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    BMS-512148-05 Suppliers

    A BMS-512148-05 supplier is an individual or a company that provides BMS-512148-05 active pharmaceutical ingredient (API) or BMS-512148-05 finished formulations upon request. The BMS-512148-05 suppliers may include BMS-512148-05 API manufacturers, exporters, distributors and traders.

    click here to find a list of BMS-512148-05 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    BMS-512148-05 USDMF

    A BMS-512148-05 DMF (Drug Master File) is a document detailing the whole manufacturing process of BMS-512148-05 active pharmaceutical ingredient (API) in detail. Different forms of BMS-512148-05 DMFs exist exist since differing nations have different regulations, such as BMS-512148-05 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A BMS-512148-05 DMF submitted to regulatory agencies in the US is known as a USDMF. BMS-512148-05 USDMF includes data on BMS-512148-05's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BMS-512148-05 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of BMS-512148-05 suppliers with USDMF on PharmaCompass.

    BMS-512148-05 KDMF

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

    Pharmaceutical companies submit a BMS-512148-05 Drug Master File in Korea (BMS-512148-05 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BMS-512148-05. The MFDS reviews the BMS-512148-05 KDMF as part of the drug registration process and uses the information provided in the BMS-512148-05 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a BMS-512148-05 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 BMS-512148-05 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of BMS-512148-05 suppliers with KDMF on PharmaCompass.

    BMS-512148-05 CEP

    A BMS-512148-05 CEP of the European Pharmacopoeia monograph is often referred to as a BMS-512148-05 Certificate of Suitability (COS). The purpose of a BMS-512148-05 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BMS-512148-05 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BMS-512148-05 to their clients by showing that a BMS-512148-05 CEP has been issued for it. The manufacturer submits a BMS-512148-05 CEP (COS) as part of the market authorization procedure, and it takes on the role of a BMS-512148-05 CEP holder for the record. Additionally, the data presented in the BMS-512148-05 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BMS-512148-05 DMF.

    A BMS-512148-05 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BMS-512148-05 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 BMS-512148-05 suppliers with CEP (COS) on PharmaCompass.

    BMS-512148-05 WC

    A BMS-512148-05 written confirmation (BMS-512148-05 WC) is an official document issued by a regulatory agency to a BMS-512148-05 manufacturer, verifying that the manufacturing facility of a BMS-512148-05 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BMS-512148-05 APIs or BMS-512148-05 finished pharmaceutical products to another nation, regulatory agencies frequently require a BMS-512148-05 WC (written confirmation) as part of the regulatory process.

    click here to find a list of BMS-512148-05 suppliers with Written Confirmation (WC) on PharmaCompass.

    BMS-512148-05 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 BMS-512148-05 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for BMS-512148-05 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 BMS-512148-05 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 BMS-512148-05 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BMS-512148-05 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of BMS-512148-05 suppliers with NDC on PharmaCompass.

    BMS-512148-05 GMP

    BMS-512148-05 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 BMS-512148-05 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 BMS-512148-05 GMP manufacturer or BMS-512148-05 GMP API supplier for your needs.

    BMS-512148-05 CoA

    A BMS-512148-05 CoA (Certificate of Analysis) is a formal document that attests to BMS-512148-05's compliance with BMS-512148-05 specifications and serves as a tool for batch-level quality control.

    BMS-512148-05 CoA mostly includes findings from lab analyses of a specific batch. For each BMS-512148-05 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.

    BMS-512148-05 may be tested according to a variety of international standards, such as European Pharmacopoeia (BMS-512148-05 EP), BMS-512148-05 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BMS-512148-05 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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