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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


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DE C.V","customerCountry":"MEXICO","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"4000","totalValueFC":"78763","currency":"USD","unitRateINR":330326.34999999998,"date":"20-Aug-2024","totalValueINR":"6606527","totalValueInUsd":"78763","indian_port":"Hyderabad Air","hs_no":"29223900","bill_no":"3333053","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NATCO HOUSE, ROAD NO.2,, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730140200,"product":"PHARMACEUTICAL RAW MATERIALS IBANDRONATE SODIUM MONOHYDRATE IH","address":"PLOT NO.68, MG NAGAR, PART-12,","city":"KANCHIPURAM DIST, CHENNAI.","supplier":"RR LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"KANEL PHARMA","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"850","totalValueFC":"839.7","currency":"USD","unitRateINR":70553.600000000006,"date":"29-Oct-2024","totalValueINR":"70553.6","totalValueInUsd":"839.7","indian_port":"Bombay Air","hs_no":"29314990","bill_no":"5229119","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.68, MG NAGAR, PART-12,, KANCHIPURAM DIST, CHENNAI.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718130600,"product":"IBANDRONATE SODIUM IH (BATCH NO. IBS\/04\/23)(RE-IMPORT)VIDE S.B.NO.4878358 DT.25.10.2023)","address":"C-4\/61 3RD FLOOR SAFDARJUNG","city":"DELHI","supplier":"LABORATORIO PASTEUR S.A.","supplierCountry":"INDIA","foreign_port":"SANTIAGO DE CHILE -","customer":"SUVAN LIFESCIENCES","customerCountry":"INDIA","quantity":"19.87","actualQuantity":"19.87","unit":"KGS","unitRateFc":"900","totalValueFC":"18716.4","currency":"USD","unitRateINR":"78632.7","date":"12-Jun-2024","totalValueINR":"1562431.69","totalValueInUsd":"18716.4","indian_port":"Delhi Air","hs_no":"29223900","bill_no":"3958117","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTIAGO DE CHILE -","supplierAddress":"IGNACIO SERRANO 568CONCEPCIONCHILE, CHILE","customerAddress":"C-4\/61 3RD FLOOR SAFDARJUNG"}]
08-Jan-2021
29-Oct-2024
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DRUG PRODUCT COMPOSITIONS

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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**

USFDA APPLICATION NUMBER - 21455

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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

Ibandronic Acid Manufacturers

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

Ibandronic Acid Suppliers

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

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

Ibandronic Acid USDMF

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

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

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

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

Ibandronic Acid KDMF

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

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

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

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

Ibandronic Acid CEP

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

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

Ibandronic Acid WC

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

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

Ibandronic Acid 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 Ibandronic Acid as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ibandronic Acid GMP

Ibandronic Acid 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 Ibandronic Acid 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 Ibandronic Acid GMP manufacturer or Ibandronic Acid GMP API supplier for your needs.

Ibandronic Acid CoA

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

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

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