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Chemistry

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Also known as: Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8
Molecular Formula
C8H8KNO5
Molecular Weight
237.25  g/mol
InChI Key
ABVRVIZBZKUTMK-JSYANWSFSA-M
FDA UNII
Q42OMW3AT8

Clavulanic Acid
A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.
1 2D Structure

Clavulanic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
potassium;(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
2.1.2 InChI
InChI=1S/C8H9NO5.K/c10-2-1-4-7(8(12)13)9-5(11)3-6(9)14-4;/h1,6-7,10H,2-3H2,(H,12,13);/q;+1/p-1/b4-1-;/t6-,7-;/m1./s1
2.1.3 InChI Key
ABVRVIZBZKUTMK-JSYANWSFSA-M
2.1.4 Canonical SMILES
C1C2N(C1=O)C(C(=CCO)O2)C(=O)[O-].[K+]
2.1.5 Isomeric SMILES
C1[C@@H]2N(C1=O)[C@H](/C(=C/CO)/O2)C(=O)[O-].[K+]
2.2 Other Identifiers
2.2.1 UNII
Q42OMW3AT8
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Brl 14151

2. Brl-14151

3. Brl14151

4. Clavulanate

5. Clavulanate, Potassium

6. Clavulanate, Sodium

7. Clavulanic Acid

8. Clavulanic Acid, Monopotassium Salt

9. Clavulanic Acid, Monosodium Salt

10. Mm 14151

11. Mm-14151

12. Mm14151

13. Potassium Clavulanate

14. Potassium, Clavulanate

15. Sodium Clavulanate

2.3.2 Depositor-Supplied Synonyms

1. Potassium Clavulanate

2. 61177-45-5

3. Clavulanic Acid Potassium Salt

4. Brl 14151k

5. Clavulanate (potassium)

6. Q42omw3at8

7. Chebi:85264

8. Brl-14151k

9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

12. Amonate

13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

14. Clavulansaeure Kaliumsalz

15. Einecs 262-640-9

16. Unii-q42omw3at8

17. Potassium Clavlanate

18. Clavulanate Potassium [usan:usp:jan]

19. Chembl1003

20. Schembl203411

21. Clavulanic Acid Potassium

22. Hy-a0256a

23. Dtxsid60210067

24. Hms3715b13

25. Clavulanate Potassium (jp17/usp)

26. Potassium Clavulanate [jan]

27. Bcp13548

28. Clavulanate Potassium [usan]

29. Clavulanate Potassium [vandf]

30. Potassium Clavulanate [mart.]

31. Potassium Clavulanate Cellulose(1:1)

32. Akos015961326

33. Clavulanate Potassium [who-dd]

34. Ccg-221126

35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-

36. Ac-13551

37. Bp-30181

38. Clavulanate Potassium [green Book]

39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate

40. Clavulanate Potassium [orange Book]

41. Potassium Clavulanate [ep Monograph]

42. Clavulanate Potassium [usp Monograph]

43. Cs-0019771

44. Augmentin Component Clavulanate Potassium

45. C-6660

46. Clavulox Component Clavulanate Potassium

47. D02370

48. D84066

49. Timentin Component Clavulanate Potassium

50. A833076

51. Clavulanate Potassium Component Of Augmentin

52. Clavulanate Potassium Component Of Clavulox

53. Clavulanate Potassium Component Of Timentin

54. Clavulanic Acid (as Clavulanate Potassium)

55. Clavulanic Acid Potassium 100 Microg/ml In Water

56. W-105420

57. Clavulanate Potassium+microcrystalline Cellulose(1:1)

58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture

59. Q27158444

60. Potassium Clavulanate (50%) : Microcrystalline Cellulose

61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only

62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only

63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt

64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-

65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 237.25 g/mol
Molecular Formula C8H8KNO5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass237.00395384 g/mol
Monoisotopic Mass237.00395384 g/mol
Topological Polar Surface Area89.9 Ų
Heavy Atom Count15
Formal Charge0
Complexity329
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

beta-Lactamase Inhibitors

Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)


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Type : Chemical

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Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748629800,"product":"POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITHMICRO CRYSTALLINE CELLULOSE)(1:1) IP (150 DRM)(BOE NO; 2164POTASSIUM CLAVULANATE DILUTED IP (POTASSIUM CLAVULANATE WITH","address":"604B, SAI SAMARTH BUSINESS PARK","city":"GOVANDI EAST","supplier":"JOINT FORCE PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"JNPT SEZ MUMBAI","customer":"STG PHARMAGENERICS PRIVATE LTD","customerCountry":"INDIA","quantity":"3465.00","actualQuantity":"3465","unit":"KGS","unitRateFc":"69.7","totalValueFC":"244899.5","currency":"USD","unitRateINR":"6021.8","date":"31-May-2025","totalValueINR":"20865600.09","totalValueInUsd":"244899.5","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"2390791","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Crystalline","supplierPort":"JNPT SEZ MUMBAI","supplierAddress":"Rm. 1110A, Tower A, Hung Hom Commer cial Center, 39 Ma Tau Wai Road Hun g Hom, Kowloon Kowloon, HONG KONG HONG KONG","customerAddress":"604B, SAI SAMARTH BUSINESS PARK"}]
01-Jan-2022
31-May-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

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DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

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DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

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DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

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DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

USFDA APPLICATION NUMBER - 50720

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DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

USFDA APPLICATION NUMBER - 50755

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50785

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ABOUT THIS PAGE

Looking for 61177-45-5 / Clavulanic Acid API manufacturers, exporters & distributors?

Clavulanic Acid manufacturers, exporters & distributors 1

34

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

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

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

API | Excipient name

Clavulanic Acid

Synonyms

Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8

Cas Number

61177-45-5

Unique Ingredient Identifier (UNII)

Q42OMW3AT8

About Clavulanic Acid

A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

Clavulanic Acid Manufacturers

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

Clavulanic Acid Suppliers

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

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

Clavulanic Acid USDMF

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

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

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

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

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

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

Clavulanic Acid CEP

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

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

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

Finished drug products

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

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

Clavulanic Acid GMP

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

Clavulanic Acid CoA

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

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

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