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Chemistry

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Also known as: 200-708-1, 69-52-3, Ampicillin sodium salt, Sodium ampicillin, Citteral, Domicillin
Molecular Formula
C16H18N3NaO4S
Molecular Weight
371.4  g/mol
InChI Key
KLOHDWPABZXLGI-YWUHCJSESA-M
FDA UNII
JFN36L5S8K

Ampicillin Sodium
Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.
1 2D Structure

Ampicillin Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
2.1.2 InChI
InChI=1S/C16H19N3O4S.Na/c1-16(2)11(15(22)23)19-13(21)10(14(19)24-16)18-12(20)9(17)8-6-4-3-5-7-8;/h3-7,9-11,14H,17H2,1-2H3,(H,18,20)(H,22,23);/q;+1/p-1/t9-,10-,11+,14-;/m1./s1
2.1.3 InChI Key
KLOHDWPABZXLGI-YWUHCJSESA-M
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=CC=C3)N)C(=O)[O-])C.[Na+]
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=CC=C3)N)C(=O)[O-])C.[Na+]
2.2 Other Identifiers
2.2.1 UNII
JFN36L5S8K
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Amcill

2. Aminobenzyl Penicillin

3. Aminobenzylpenicillin

4. Ampicillin

5. Ampicillin Trihydrate

6. Antibiotic Ks R1

7. Antibiotic Ks-r1

8. Ks-r1, Antibiotic

9. Omnipen

10. Penicillin, Aminobenzyl

11. Pentrexyl

12. Polycillin

13. Sodium, Ampicillin

14. Trihydrate, Ampicillin

15. Ukapen

2.3.2 Depositor-Supplied Synonyms

1. 200-708-1

2. 69-52-3

3. Ampicillin Sodium Salt

4. Sodium Ampicillin

5. Citteral

6. Domicillin

7. Penialmen

8. Ampicillin Natrium

9. Omnipen

10. Penbritin

11. Totacillin

12. Ampicillin (sodium)

13. Austrapen

14. Polycillin-n

15. Sodium D-(-)-alpha-aminobenzylpenicillin

16. Totacillin-n

17. Penbritin-s

18. Omnipen-n

19. Ampicillin (as Sodium)

20. Jfn36l5s8k

21. Mls000028726

22. D(-)-alpha-aminobenzylpenicillin Sodium Salt

23. Chebi:34535

24. Nsc-755864

25. Smr000059229

26. Monosodium D-(-)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate

27. Sodium (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

28. Ampicillinsodium

29. Binotal Sodium

30. Sodium Binotal

31. Principen/n

32. Amcill-s

33. Alpen-n

34. Sodium;(2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

35. Sodium P-50

36. Mfcd00064313

37. Pen A/n

38. Unii-jfn36l5s8k

39. Ampiplus Simplex

40. Viccillin (tn)

41. Prestwick_822

42. Ampicillin Sodium [usan:usp:jan]

43. Einecs 200-708-1

44. Ampicillinum Natricum

45. Omnipen-n (tn)

46. Ampicillin Sodium Salt, Cell Culture Grade

47. Opera_id_709

48. (2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Sodium Salt

49. Ampicillinsodiumsalt

50. Ampicillin Sodium, Sterile

51. Schembl40521

52. Spectrum1500123

53. Ampicillin Sodium [jan]

54. Ampicillin Sodium (jp17/usp)

55. Ampicillin Sodium [usan]

56. Chembl1200758

57. Hms501h08

58. Hy-b0522a

59. Ampicillin Sodium [vandf]

60. Dtxsid60988759

61. Ampicillin Sodium [mart.]

62. Hms1920c21

63. Hms2091i21

64. Hms2232j12

65. Ampicillin Sodium [usp-rs]

66. Ampicillin Sodium [who-dd]

67. Ampicillin Sodium [who-ip]

68. Ampicillin Sodium Salt [mi]

69. Ccg-39691

70. S3170

71. Akos015967315

72. Akos025147373

73. Ampicillin Sodium [green Book]

74. Ac-8806

75. Ampicillin Sodium [orange Book]

76. Nsc 755864

77. Ampicillin Sodium [ep Monograph]

78. Ampicillin Sodium [usp Monograph]

79. D-(-)-alpha-aminobenzylpenicillin &sdot

80. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, (2s-(2alpha,5alpha,6beta(s*)))-

81. Ba166035

82. Monosodium (2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate

83. D-(-)-a-aminobenzylpenicillin Sodium Salt

84. Ampicillin Sodium, Sterile [who-ip]

85. Ampicillinum Natricum [who-ip Latin]

86. Sw220219-1

87. A-7700

88. D02119

89. A836527

90. Ampicillin Sodium (non-injectable) [who-ip]

91. Q27116136

92. Ampicillin Sodium Salt, Antibiotic For Culture Media Use Only

93. Sodium 6beta-[(2r)-2-amino-2-phenylacetamido]-2,2-dimethylpenam-3alpha-carboxylate

94. (2s,5r,6r)-6-[[(2r)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, Sodium Salt (1:1)

95. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((aminophenylacetyl)amino)-3,3-dimethyl-7-oxo-, Monosodium Salt, (2s-(2.alpha.,5.alpha.,6.beta.(s*)))-

96. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-, Sodium Salt, D-(-)-

97. 6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-,sodiumsalt,d-(-)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylicacid

98. Sodium (2s-(2alpha,5alpha,6beta(s*)))-6-(aminophenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate

99. Sodium(2s,5r,6r)-6-((r)-2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 371.4 g/mol
Molecular Formula C16H18N3NaO4S
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass371.09157152 g/mol
Monoisotopic Mass371.09157152 g/mol
Topological Polar Surface Area141 Ų
Heavy Atom Count25
Formal Charge0
Complexity568
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameAmpicillin sodium
Drug LabelAmpicillin for Injection, USP the monosodium salt of [2S-[2,5,6(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intramuscular or intravenous use. The pha...
Active IngredientAmpicillin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 250mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyIstituto Bio Ita Spa; Antibiotice; Hanford Gc; Acs Dobfar Spa; Aurobindo Pharma; Strides Arcolab; Sandoz; Agila Speclts

2 of 2  
Drug NameAmpicillin sodium
Drug LabelAmpicillin for Injection, USP the monosodium salt of [2S-[2,5,6(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intramuscular or intravenous use. The pha...
Active IngredientAmpicillin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 250mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyIstituto Bio Ita Spa; Antibiotice; Hanford Gc; Acs Dobfar Spa; Aurobindo Pharma; Strides Arcolab; Sandoz; Agila Speclts

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Penicillins [CS]; Penicillin-class Antibacterial [EPC]

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ABOUT THIS PAGE

Looking for 69-52-3 / Ampicillin Sodium API manufacturers, exporters & distributors?

Ampicillin Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ampicillin Sodium

Synonyms

200-708-1, 69-52-3, Ampicillin sodium salt, Sodium ampicillin, Citteral, Domicillin

Cas Number

69-52-3

Unique Ingredient Identifier (UNII)

JFN36L5S8K

About Ampicillin Sodium

Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.

AMPICILLIN SODIUM [EP MONOGRAPH] Manufacturers

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

AMPICILLIN SODIUM [EP MONOGRAPH] Suppliers

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

click here to find a list of AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] USDMF

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

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

click here to find a list of AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with USDMF on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] Drug Master File in Japan (AMPICILLIN SODIUM [EP MONOGRAPH] JDMF) empowers AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] JDMF during the approval evaluation for pharmaceutical products. At the time of AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with JDMF on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] KDMF

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

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

After submitting a AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] API can apply through the Korea Drug Master File (KDMF).

click here to find a list of AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with KDMF on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] CEP

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

A AMPICILLIN SODIUM [EP MONOGRAPH] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with CEP (COS) on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] WC

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

click here to find a list of AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with Written Confirmation (WC) on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of AMPICILLIN SODIUM [EP MONOGRAPH] suppliers with NDC on PharmaCompass.

AMPICILLIN SODIUM [EP MONOGRAPH] GMP

AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] 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 AMPICILLIN SODIUM [EP MONOGRAPH] GMP manufacturer or AMPICILLIN SODIUM [EP MONOGRAPH] GMP API supplier for your needs.

AMPICILLIN SODIUM [EP MONOGRAPH] CoA

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

AMPICILLIN SODIUM [EP MONOGRAPH] CoA mostly includes findings from lab analyses of a specific batch. For each AMPICILLIN SODIUM [EP MONOGRAPH] 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.

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