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    Chemistry

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    Also known as: 138844-81-2, Bondronat, Ibandronate sodium salt, Boniva, Ibandronate (sodium), Sodium ibandronate
    Molecular Formula
    C9H22NNaO7P2
    Molecular Weight
    341.21  g/mol
    InChI Key
    LXLBEOAZMZAZND-UHFFFAOYSA-M
    FDA UNII
    23Y0B94E49
    Ibandronate Sodium
    Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.
    1 2D Structure

    Ibandronate Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate
    2.1.2 InChI
    InChI=1S/C9H23NO7P2.Na/c1-3-4-5-7-10(2)8-6-9(11,18(12,13)14)19(15,16)17;/h11H,3-8H2,1-2H3,(H2,12,13,14)(H2,15,16,17);/q;+1/p-1
    2.1.3 InChI Key
    LXLBEOAZMZAZND-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)[O-].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    23Y0B94E49
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonate

    2. 1-hydroxy-3-(methylpentylamino)propylidenebisphosphonate

    3. Bm 21.0955

    4. Bm 210955

    5. Bm-21.0955

    6. Bm-210955

    7. Bm21.0955

    8. Bm210955

    9. Bondronat

    10. Boniva

    11. Bonviva

    12. Ibandronate

    13. Ibandronate Sodium Anhydrous

    14. Ibandronic Acid

    15. Ibandronic Acid, Sodium Salt, Monohydrate

    16. Rpr 102289a

    17. Rpr-102289a

    18. Rpr102289a

    2.3.2 Depositor-Supplied Synonyms

    1. 138844-81-2

    2. Bondronat

    3. Ibandronate Sodium Salt

    4. Boniva

    5. Ibandronate (sodium)

    6. Sodium Ibandronate

    7. Ibandronate Sodium Anhydrous

    8. Bonviva

    9. 23y0b94e49

    10. (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonic Acid Sodium

    11. Sodium;hydroxy-[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate

    12. Phosphonic Acid, (1-hydroxy-3-(methylpentylamino)propylidene)bis-, Monosodium Salt

    13. Bm 21.0955na

    14. Ncgc00167428-01

    15. Bm-21.0955

    16. Unii-23y0b94e49

    17. Dsstox_cid_26618

    18. Dsstox_rid_81770

    19. Dsstox_gsid_46618

    20. Schembl1030768

    21. Chembl1201008

    22. Dtxsid8046618

    23. Hy-b0515b

    24. Hms3263m08

    25. Hms3714g19

    26. Sodium Ibandronate Anhydrous

    27. Bcp22744

    28. Ibandronate Sodium [who-dd]

    29. Tox21_112432

    30. Tox21_501103

    31. Mfcd07197214

    32. Akos026750153

    33. Bcp9000767

    34. Ccg-220679

    35. Ccg-222407

    36. Lp01103

    37. Ibandronic Acid Sodium Salt [mi]

    38. Ncgc00261788-01

    39. Cas-138844-81-2

    40. Ft-0670252

    41. S0877

    42. H11437

    43. Ibandronate Sodium Salt, >=97% (nmr), Solid

    44. J-007183

    45. Q27253790

    46. (1-hydroxy-3-(methyl(pentyl)amino)propane-1,1-diyl)diphosphonic Acid Monosodium Salt

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 341.21 g/mol
    Molecular Formula C9H22NNaO7P2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass341.07692032 g/mol
    Monoisotopic Mass341.07692032 g/mol
    Topological Polar Surface Area141 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity377
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameBoniva
    PubMed HealthIbandronate
    Drug ClassesCalcium Regulator
    Drug LabelBONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
    Active IngredientIbandronate sodium
    Dosage FormInjectable; Tablet
    RouteIntravenous; Oral
    Strengtheq 3mg base/3ml; eq 150mg base
    Market StatusPrescription
    CompanyHoffmann La Roche; Roche

    2 of 4  
    Drug NameIbandronate sodium
    Drug LabelBONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
    Active IngredientIbandronate sodium
    Dosage FormTablet; Injectable
    Routeinjection; oral; Oral; Intravenous
    Strength2.5mg; 1mg; eq 150mg base; eq 3mg base/3ml
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Teva Parenteral; Apotex; Sun Pharm Inds; Watson Labs; Emcure Pharms; Mutual Pharm; Cobalt Labs; Sagent Pharms; Dr Reddys Labs; Agila Speclts; Orchid Hlthcare

    3 of 4  
    Drug NameBoniva
    PubMed HealthIbandronate
    Drug ClassesCalcium Regulator
    Drug LabelBONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
    Active IngredientIbandronate sodium
    Dosage FormInjectable; Tablet
    RouteIntravenous; Oral
    Strengtheq 3mg base/3ml; eq 150mg base
    Market StatusPrescription
    CompanyHoffmann La Roche; Roche

    4 of 4  
    Drug NameIbandronate sodium
    Drug LabelBONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, mon...
    Active IngredientIbandronate sodium
    Dosage FormTablet; Injectable
    Routeinjection; oral; Oral; Intravenous
    Strength2.5mg; 1mg; eq 150mg base; eq 3mg base/3ml
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Teva Parenteral; Apotex; Sun Pharm Inds; Watson Labs; Emcure Pharms; Mutual Pharm; Cobalt Labs; Sagent Pharms; Dr Reddys Labs; Agila Speclts; Orchid Hlthcare

    4.2 Drug Indication

    Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5. 1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

    Bondronat is indicated for:

    - prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases;

    - treatment of tumour-induced hypercalcaemia with or without metastases.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Bone Density Conservation Agents

    Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Diphosphonates [CS]; Bisphosphonate [EPC]
    5.3 ATC Code

    M05BA06

    M05BA06

    API Reference Price

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    15-Apr-2021
    29-Oct-2024
    KGS
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    Average Price (USD/KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21455

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    DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21858

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    ABOUT THIS PAGE

    Ibandronate Sodium Monohydrate Manufacturers

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

    Ibandronate Sodium Monohydrate Suppliers

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

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

    Ibandronate Sodium Monohydrate USDMF

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

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

    click here to find a list of Ibandronate Sodium Monohydrate suppliers with USDMF on PharmaCompass.

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

    Ibandronate Sodium Monohydrate KDMF

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

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

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

    click here to find a list of Ibandronate Sodium Monohydrate suppliers with KDMF on PharmaCompass.

    Ibandronate Sodium Monohydrate CEP

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

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

    Ibandronate Sodium Monohydrate WC

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

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

    Ibandronate Sodium Monohydrate 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 Ibandronate Sodium Monohydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Ibandronate Sodium Monohydrate suppliers with NDC on PharmaCompass.

    Ibandronate Sodium Monohydrate GMP

    Ibandronate Sodium Monohydrate 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 Ibandronate Sodium Monohydrate 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 Ibandronate Sodium Monohydrate GMP manufacturer or Ibandronate Sodium Monohydrate GMP API supplier for your needs.

    Ibandronate Sodium Monohydrate CoA

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

    Ibandronate Sodium Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Ibandronate Sodium Monohydrate 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.

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