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Chemistry

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Also known as: Cloxacillin sodium, 7081-44-9, Cloxacillin sodium monohydrate, Bactopen, Sodium cloxacillin monohydrate, Tegopen
Molecular Formula
C19H19ClN3NaO6S
Molecular Weight
475.9  g/mol
InChI Key
KCUWTKOTPIUBRI-VICXVTCVSA-M
FDA UNII
65LCB00B4Y

Cloxacillin Sodium
A semi-synthetic antibiotic that is a chlorinated derivative of OXACILLIN.
1 2D Structure

Cloxacillin Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(2S,5R,6R)-6-[[3-(2-chlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate;hydrate
2.1.2 InChI
InChI=1S/C19H18ClN3O5S.Na.H2O/c1-8-11(12(22-28-8)9-6-4-5-7-10(9)20)15(24)21-13-16(25)23-14(18(26)27)19(2,3)29-17(13)23;;/h4-7,13-14,17H,1-3H3,(H,21,24)(H,26,27);;1H2/q;+1;/p-1/t13-,14+,17-;;/m1../s1
2.1.3 InChI Key
KCUWTKOTPIUBRI-VICXVTCVSA-M
2.1.4 Canonical SMILES
CC1=C(C(=NO1)C2=CC=CC=C2Cl)C(=O)NC3C4N(C3=O)C(C(S4)(C)C)C(=O)[O-].O.[Na+]
2.1.5 Isomeric SMILES
CC1=C(C(=NO1)C2=CC=CC=C2Cl)C(=O)N[C@H]3[C@@H]4N(C3=O)[C@H](C(S4)(C)C)C(=O)[O-].O.[Na+]
2.2 Other Identifiers
2.2.1 UNII
65LCB00B4Y
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Chloroxacillin

2. Cloxacillin

3. Cloxacillin Sodium

4. Cloxacillin, Sodium

5. Sodium Cloxacillin

6. Sodium, Cloxacillin

7. Syntarpen

8. Tegopen

2.3.2 Depositor-Supplied Synonyms

1. Cloxacillin Sodium

2. 7081-44-9

3. Cloxacillin Sodium Monohydrate

4. Bactopen

5. Sodium Cloxacillin Monohydrate

6. Tegopen

7. Orbenin

8. Cloxacillin Sodium Hydrate

9. Ekvacillin

10. Latocillin

11. Cloxypen

12. Methocillin-s

13. Cloxacillin Sodium Salt Monohydrate

14. Cloxacillin (sodium Monohydrate)

15. Cloxacillin (as Sodium)

16. Brl-1621

17. P-25

18. 65lcb00b4y

19. Chebi:34978

20. Monosodium (2s,5r,6r)-6-(3-(o-chlorophenyl)-5-methyl-4-isoxazolecarboxamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate Monohydrate

21. Sodium (2s,5r,6r)-6-(3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Hydrate

22. Sodium;(2s,5r,6r)-6-[[3-(2-chlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate;hydrate

23. Staphobristol-250

24. Orbenin Sodium Hydrate

25. Cloxacap

26. Prostaphlin-a Monohydrate

27. Brl-1621 Sodium Salt Monohydrate

28. Unii-65lcb00b4y

29. Cloxacillin Nataarium-1-wasser

30. Cloxapen (tn)

31. Tegopen (tn)

32. Cloxacillin Sodium [usan:usp:jan]

33. 642-78-4

34. Cloxacillin Sodium (usp)

35. Schembl41012

36. Chembl1200388

37. Cloxacillin Sodium [usan]

38. Dtxsid60110018

39. Cloxacillin Sodium [vandf]

40. Bcp13532

41. Cloxacillin Sodium [usp-rs]

42. Cloxacillin Sodium [who-dd]

43. Cloxacillin Sodium [who-ip]

44. Cloxacillin Sodium Hydrate (jp17)

45. Hy-b0466

46. Mfcd00150735

47. S2564

48. Akos015896310

49. Akos015962898

50. Ac-7623

51. Ccg-269503

52. Cloxacillin Sodium [green Book]

53. Cloxacillin Sodium [orange Book]

54. Cloxacillin Sodium Hydrate [jan]

55. Cloxacillin Sodium [ep Monograph]

56. Cloxacillin Sodium [usp Impurity]

57. 1,3-dichloro-7-bromoisoquinoline

58. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((3-(2-chlorophenyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, Monohydrate, (2s-(2alpha,5alpha,6beta))-

59. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(3-(o-chlorophenyl)-5-methyl-4-isoxazolecarboxamido)-3,3-dimethyl-7-oxo-, Sodium Salt, Monohydrate

60. As-60182

61. Cloxacillin Sodium [usp Monograph]

62. D02231

63. Ab01568256_01

64. Cloxacillin Sodium Salt Monohydrate [mi]

65. Q-200886

66. Cloxacillin Sodium Hydrate 100 Microg/ml In Methanol

67. Q27116347

68. Z2574937894

69. Cloxacillin Sodium, Antibiotic For Culture Media Use Only

70. Cloxacillin Sodium, European Pharmacopoeia (ep) Reference Standard

71. Cloxacillin Sodium Salt Monohydrate, Beta-lactamase-resistant Antibiotic

72. Cloxacillin Sodium Salt Monohydrate, Vetranal(tm), Analytical Standard

73. Cloxacillin Sodium, United States Pharmacopeia (usp) Reference Standard

74. Cloxacillin Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

75. (2s,5r,6r)-6-[[3-(2-chlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

76. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((3-(2-chlorophenyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, Monohydrate, (2s-(2.alpha.,5.alpha.,6.beta.))-

77. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((3-(2-chlorophenyl)-5-methyl-4-isoxazolyl)carbonyl)amino)-3,3-dimethyl-7-oxo-, Sodium Salt, Hydrate (1:1:1), (2s,5r,6r)-

78. Sodium (2s,5r,6r)-6-[[3-(2-chlorophenyl)-5-methyl1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Hydrate

79. Sodium (2s,5r,6r)-6-[3-(2-chlorophenyl)-5-methyl-1,2-oxazole-4-amido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Hydrate

80. Sodium 2,2-dimethyl-6beta-({[5-methyl-3-(2-chlorophenyl)isoxazol-4-yl]carbonyl}amino)penam-3alpha-carboxylate Hydrate

2.3.3 Other Synonyms

1. 642-78-4

2. Cloxacillin Sodium Anhydrous

3. Sodium Orbenin

4. Syntarpen Sodium Salt

5. Monosodium Cloxacillin

6. Sodium Syntarpen

7. Austrastaph

8. Staphybiotic

9. Ankerbin

10. Ekvacillin

11. Gelstaph

12. Cloxacillin Sodium Salt

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 475.9 g/mol
Molecular Formula C19H19ClN3NaO6S
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass475.0580785 g/mol
Monoisotopic Mass475.0580785 g/mol
Topological Polar Surface Area142 Ų
Heavy Atom Count31
Formal Charge0
Complexity728
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
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.)


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Cloxacillin Sodium Hydrate

Registration Number : 227MF10133

Registrant's Address : Bhai Mohan Singh Nagar, Toansa, District SBS Nagar (Nawanshahr), Punjab-144 533, Indi...

Initial Date of Registration : 2015-04-30

Latest Date of Registration : 2015-04-30

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[Japanese Pharmacopoeia] Cloxacillin Sodium

Registration Number : 218MF11024

Registrant's Address : 12 BONGEUNSA-RO, 114-GIL, GANGNAM-GU, SEOUL, 135-715 KOREA

Initial Date of Registration : 2006-12-28

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Cloxacillin Sodium IP/BP/USP/EP

Date of Issue : 2022-05-19

Valid Till : 2025-05-27

Written Confirmation Number : WC-0010

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Cloxacillin Sodium (Sterile) Ph. Eur.

Date of Issue : 2022-08-02

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Date of Issue : 2022-06-07

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Cloxacillin Sodium Sterile IP

Date of Issue : 2024-04-23

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Written Confirmation Number : WC-0420

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Date of Issue : 2022-08-12

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Date of Issue : 2022-12-20

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Written Confirmation Number : WC-0470

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CLOXACILLIN SODIUM

NDC Package Code : 52946-0701

Start Marketing Date : 2009-12-09

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CLOXACILLIN SODIUM

NDC Package Code : 66558-0211

Start Marketing Date : 2022-07-29

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

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03-Jan-2022
30-Jun-2025
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ABOUT THIS PAGE

Looking for 7081-44-9 / Cloxacillin Sodium API manufacturers, exporters & distributors?

Cloxacillin Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cloxacillin Sodium 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 Cloxacillin Sodium manufacturer or Cloxacillin Sodium supplier for your needs.

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

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

API | Excipient name

Cloxacillin Sodium

Synonyms

7081-44-9, Cloxacillin sodium monohydrate, Bactopen, Sodium cloxacillin monohydrate, Tegopen, Orbenin

Cas Number

7081-44-9

Unique Ingredient Identifier (UNII)

65LCB00B4Y

About Cloxacillin Sodium

A semi-synthetic antibiotic that is a chlorinated derivative of OXACILLIN.

Cloxacillin Manufacturers

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

Cloxacillin Suppliers

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

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

Cloxacillin USDMF

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

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

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

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

Cloxacillin CEP

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

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

Cloxacillin WC

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

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

Cloxacillin 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 Cloxacillin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cloxacillin GMP

Cloxacillin 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 Cloxacillin 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 Cloxacillin GMP manufacturer or Cloxacillin GMP API supplier for your needs.

Cloxacillin CoA

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

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

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