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Also known as: 69388-84-7, Sulbactam sodium salt, Sodium sulbactam, Combactam, Sulbactam (sodium), Sulbactam (as sodium)
Molecular Formula
C8H10NNaO5S
Molecular Weight
255.23  g/mol
InChI Key
NKZMPZCWBSWAOX-IBTYICNHSA-M
FDA UNII
DKQ4T82YE6

Sulbactam Sodium
A beta-lactamase inhibitor with very weak antibacterial action. The compound prevents antibiotic destruction of beta-lactam antibiotics by inhibiting beta-lactamases, thus extending their spectrum activity. Combinations of sulbactam with beta-lactam antibiotics have been used successfully for the therapy of infections caused by organisms resistant to the antibiotic alone.
1 2D Structure

Sulbactam Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(2S,5R)-3,3-dimethyl-4,4,7-trioxo-46-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
2.1.2 InChI
InChI=1S/C8H11NO5S.Na/c1-8(2)6(7(11)12)9-4(10)3-5(9)15(8,13)14;/h5-6H,3H2,1-2H3,(H,11,12);/q;+1/p-1/t5-,6+;/m1./s1
2.1.3 InChI Key
NKZMPZCWBSWAOX-IBTYICNHSA-M
2.1.4 Canonical SMILES
CC1(C(N2C(S1(=O)=O)CC2=O)C(=O)[O-])C.[Na+]
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1(=O)=O)CC2=O)C(=O)[O-])C.[Na+]
2.2 Other Identifiers
2.2.1 UNII
DKQ4T82YE6
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Btamaze

2. Combactam

3. Cp 45899

4. Cp-45899

5. Cp45899

6. Penicillanic Acid Sulfone

7. Sodium, Sulbactam

8. Sulbactam

9. Sulfone, Penicillanic Acid

2.3.2 Depositor-Supplied Synonyms

1. 69388-84-7

2. Sulbactam Sodium Salt

3. Sodium Sulbactam

4. Combactam

5. Sulbactam (sodium)

6. Sulbactam (as Sodium)

7. Dkq4t82ye6

8. Sodium (2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide

9. Sodium;(2s,5r)-3,3-dimethyl-4,4,7-trioxo-4lambda6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

10. Cp-45899-2

11. Cp-45,899-2

12. Sodium 1,1-dioxopenicillanate

13. Cp-458992

14. Sulbactam Sodium (unasyn)

15. Sodium Penicillanate 1,1-dioxide

16. Sulbactam Natrium

17. Cp 45899 Sodium Salt

18. Penicillanic Acid Dioxide Sodium Salt

19. Penicillanic Acid Sulfone Sodium Salt

20. Unii-dkq4t82ye6

21. Cp 45899-2

22. Sulbactam Sodium [usan:usp:jan]

23. Sodium (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate 4,4-dioxide

24. Sodium (2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate 4,4-dioxide

25. Einecs 273-984-4

26. Cp 45899 Sodium

27. Penicillanic Acid 1,1-dioxide Sodium Salt

28. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, Sodium Salt, (2s,5r)- (9ci)

29. Schembl667857

30. Sulbactam Sodium [jan]

31. Sulbactam Sodium (jp17/usp)

32. Sulbactam Sodium [usan]

33. Chembl1200944

34. Sulbactam Sodium [vandf]

35. Hy-b0334a

36. Sulbactam Sodium [mart.]

37. Chebi:157785

38. Sulbactam Sodium [who-dd]

39. Dtxsid401026661

40. Hms3651h07

41. Sulbactam Sodium Salt [mi]

42. Akos015963378

43. Sulbactam Sodium [ep Impurity]

44. Sulbactam Sodium [orange Book]

45. Ccg-267009

46. Sulbactam Sodium [ep Monograph]

47. Sulbactam Sodium [usp Impurity]

48. Sulbactam Sodium [usp Monograph]

49. Ac-20083

50. Cs-0013161

51. S2551

52. Sulperazone Component Sulbactam Sodium

53. D02223

54. Sulbactam Sodium Component Of Sulperazone

55. W-104633

56. Q27276453

57. Sulbactam Sodium, Antibiotic For Culture Media Use Only

58. (2s,5r)-3,3-dimethyl-4,4,7-trioxo-4$l^{6}-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

59. (2s,5r)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide Sodium Salt

60. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, Sodium Salt, (2s-cis)-

61. Sodium(2s-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate4,4-dioxide

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 255.23 g/mol
Molecular Formula C8H10NNaO5S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count5
Rotatable Bond Count1
Exact Mass255.01773788 g/mol
Monoisotopic Mass255.01773788 g/mol
Topological Polar Surface Area103 Ų
Heavy Atom Count16
Formal Charge0
Complexity452
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


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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23-Jan-2021
22-Nov-2024
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ABOUT THIS PAGE

Sulbactam Sodium Manufacturers

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

Sulbactam Sodium Suppliers

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

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

Sulbactam Sodium USDMF

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

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

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

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

Sulbactam Sodium KDMF

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

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

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

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

Sulbactam Sodium CEP

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

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

Sulbactam Sodium WC

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

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

Sulbactam Sodium 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 Sulbactam Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sulbactam Sodium GMP

Sulbactam Sodium 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 Sulbactam Sodium 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 Sulbactam Sodium GMP manufacturer or Sulbactam Sodium GMP API supplier for your needs.

Sulbactam Sodium CoA

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

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

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