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Chemistry

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Also known as: 127-09-3, Acetic acid, sodium salt, Sodium acetate anhydrous, Acetic acid sodium salt, Sodium acetate, anhydrous, Anhydrous sodium acetate
Molecular Formula
C2H3NaO2
Molecular Weight
82.03  g/mol
InChI Key
VMHLLURERBWHNL-UHFFFAOYSA-M
FDA UNII
NVG71ZZ7P0

Sodium Acetate
The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.
1 2D Structure

Sodium Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;acetate
2.1.2 InChI
InChI=1S/C2H4O2.Na/c1-2(3)4;/h1H3,(H,3,4);/q;+1/p-1
2.1.3 InChI Key
VMHLLURERBWHNL-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CC(=O)[O-].[Na+]
2.2 Other Identifiers
2.2.1 UNII
NVG71ZZ7P0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Sodium Acetate Trihydrate

2. Sodium Acetate, Anhydrous

2.3.2 Depositor-Supplied Synonyms

1. 127-09-3

2. Acetic Acid, Sodium Salt

3. Sodium Acetate Anhydrous

4. Acetic Acid Sodium Salt

5. Sodium Acetate, Anhydrous

6. Anhydrous Sodium Acetate

7. Sodium Ethanoate

8. Fema No. 3024

9. Sodium-acetate

10. Acetic Acid, Sodium Salt (1:1)

11. Sodium;acetate

12. Mfcd00012459

13. Natriumacetat

14. Sodium Acetate,anhydrous

15. Nvg71zz7p0

16. Chebi:32954

17. Sodii Acetas

18. Natriumazetat

19. Nsc-77459

20. Natrium Aceticum

21. Octan Sodny [czech]

22. Caswell No. 741a

23. Natriumacetat [german]

24. Chembl1354

25. Fema Number 3024

26. Octan Sodny

27. Naoac

28. Hsdb 688

29. Sodium Acetate In Plastic Container

30. Einecs 204-823-8

31. Nsc 77459

32. Unii-nvg71zz7p0

33. Epa Pesticide Chemical Code 044006

34. Sodiumacetate

35. Sodium Aceate

36. Acona

37. Scfa

38. Ch3coona

39. Acetic Acidsodium Salt

40. Sodium Acetate Solution

41. Short Chain Fatty Acids

42. Sodium Acetate ,(s)

43. Ch3co2na

44. Dsstox_cid_7044

45. Ec 204-823-8

46. Dsstox_rid_78290

47. Sodium Acetate [mi]

48. Dsstox_gsid_27044

49. Sodium Acetate, Acs Reagent

50. Sodium Acetate [fhfi]

51. Sodium Acetate [hsdb]

52. Dtxsid2027044

53. Sodium Acetate [who-dd]

54. Sodium Acetate Solution, 0.3 M

55. Sodium Acetate, Biochemical Grade

56. Sodium Acetate Anhydrous Acs Usp

57. Tox21_202741

58. Sodium Acetate Anhydrous [ii]

59. Akos003052995

60. Akos015837569

61. Sodium Acetate, Bioxtra, >=99.0%

62. Db09395

63. Sodium Acetate, Reagentplus(r), 99%

64. Sodium Acetate, For Hplc, >=99.5%

65. Sodium Acetate,anhydrous [vandf]

66. Acetate, 1m Buffer Solution, Ph, 3.0

67. Acetate, 1m Buffer Solution, Ph, 3.5

68. Acetate, 1m Buffer Solution, Ph, 4.0

69. Acetate, 1m Buffer Solution, Ph, 5.0

70. Acetate, 1m Buffer Solution, Ph, 5.5

71. Ncgc00260289-01

72. Sodium Acetate, Ar, Anhydrous, >=99%

73. Sodium Acetate, Lr, Anhydrous, >=98%

74. Cas-127-09-3

75. E262

76. Sodium Acetate, Acs Reagent, >=99.0%

77. B7296

78. Ft-0635282

79. Ft-0659959

80. Ft-0689166

81. S0559

82. Sodium Acetate Anhydrous, >99%, Fcc, Fg

83. Sodium Acetate Anhydrous [orange Book]

84. Sodium Acetate, 99.995% Trace Metals Basis

85. Sodium Acetate, Saj First Grade, >=98.0%

86. Sodium Acetate, Trace Metals Grade, 99.99%

87. Sodium Acetate Anhydrous Acs Grade 12kg

88. Sodium Acetate, Jis Special Grade, >=98.5%

89. Sodium Acetate, Vetec(tm) Reagent Grade, 98%

90. Sodium Acetate Anhydrous [usp Monograph]

91. A805637

92. Q339940

93. J-005463

94. Sodium Acetate, For Hplc, 99.0-101.0% (nt)

95. Sodium Acetate, Puriss., Anhydrous, >=98%, Powder

96. Sodium Acetate, Anhydrous, Reagentplus(r), >=99.0%

97. Sodium Acetate, Anhydrous, For Molecular Biology, >=99%

98. Sodium Acetate, For Electrophoresis, >=99%, Crystalline

99. Sodium Acetate, 1m Aqueous Solution, Ph 4.5, Rnase Free

100. Sodium Acetate, 3m Aqueous Solution, Ph 4.5, Autoclaved

101. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Autoclaved

102. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Rnase Free

103. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Autoclaved

104. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Rnase Free

105. Sodium Acetate, Meets Usp Testing Specifications, Anhydrous

106. Sodium Acetate, United States Pharmacopeia (usp) Reference Standard

107. Sodium Acetate Solution, Bioultra, For Molecular Biology, ~3 M In H2o

108. Sodium Acetate, Bioultra, For Luminescence, Anhydrous, >=99.0% (nt)

109. Sodium Acetate, Puriss. P.a., Acs Reagent, Reag. Ph. Eur., Anhydrous

110. Sodium Acetate, Anhydrous, Bioultra, For Luminescence, For Molecular Biology, >=99.0% (nt)

111. Sodium Acetate, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99.0%

112. Mettler-toledo Calibration Substance Me 30130599, Sodium Acetate Anhydrous, Tracable To Primary Standards (lgc)

113. Sodium Acetate Solution, Nmr Reference Standard, 50 Mm In D2o (99.9 Atom % D), Water 1 %, Nmr Tube Size 3 Mm X 8 In.

114. Sodium Acetate, Powder, Bioreagent, For Electrophoresis, Suitable For Cell Culture, Suitable For Insect Cell Culture, >=99%

2.4 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 82.03 g/mol
Molecular Formula C2H3NaO2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count2
Rotatable Bond Count0
Exact Mass82.00307362 g/mol
Monoisotopic Mass82.00307362 g/mol
Topological Polar Surface Area40.1 Ų
Heavy Atom Count5
Formal Charge0
Complexity34.6
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 NameSodium acetate in plastic container
Active IngredientSodium acetate anhydrous
Dosage FormInjectable
RouteInjection
Strength2meq/ml
Market StatusPrescription
CompanyHospira

2 of 2  
Drug NameSodium acetate in plastic container
Active IngredientSodium acetate anhydrous
Dosage FormInjectable
RouteInjection
Strength2meq/ml
Market StatusPrescription
CompanyHospira

4.2 Therapeutic Uses

Diuretics; Expectorants; Pharmaceutic Aids

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


/FORMER USE/: HYOSCYAMUS SODIUM ACETATE, & PHENOBARBITAL ELIXIR COMBINES SMOOTH MUSCLE ANTISPASMODIC ACTION OF ... HYOSCYAMUS, WITH URINARY ALKALINIZING & DIURETIC EFFECTS OF SODIUM ACETATE, & SEDATIVE EFFECTS OF PHENOBARBITAL. /IT IS/ USED IN MANAGEMENT OF CYSTITIS & FOR BLADDER IRRITATION.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00


DOSAGE OF ELIXIR OF HYOSCYAMUS CMPD /CONTAINING SODIUM ACETATE & PHENOBARBITAL/ IS 5 ML GIVEN 3 TIMES DAILY BEFORE MEALS.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00


... /SODIUM ACETATE/ HAS BEEN USED FOR PARENTERAL THERAPY OF ACIDOTIC CONDITIONS. IT IS BOTH A SYSTEMIC & URINARY ALKALIZER. /SODIUM ACETATE TRIHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772


For more Therapeutic Uses (Complete) data for SODIUM ACETATE (8 total), please visit the HSDB record page.


4.3 Drug Indication

Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium acetate and other bicarbonate precursors are alkalinising agents, and can be used to correct metabolic acidosis, or for alkalinisation of the urine.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/liter. The sodium ion exerts a primary role in controlling total body water and its distribution. Acetate ions acts as hydrogen ion acceptor which is alternative to bicarbonate.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Increased Large Intestinal Motility [PE]
5.3 ATC Code

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA08 - Sodium acetate


5.4 Absorption, Distribution and Excretion

Absorption

It is readily available in the circulation after IV administration.


Route of Elimination

Both the sodium and bicarbonate ions are excreted mainly in the urine. Some sodium is excreted in the feces, and small amounts may also be excreted in saliva, sweat, bile and pancreatic secretions.


5.5 Metabolism/Metabolites

In liver, sodium acetate is being metabolized into bicarbonate. To form bicarbonate, acetate is slowly hydrolyzed to carbon dioxide and water, which are then converted to bicarbonate by the addition of a hydrogen ion.


THE ACETATE ION IS RAPIDLY & COMPLETELY METABOLIZED BY BODY, & CONSEQUENTLY ADMIN OF SODIUM ACETATE IS EVENTUALLY EQUIVALENT TO GIVING SODIUM BICARBONATE. /SODIUM ACETATE TRIHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772


CONSTANT RATE INFUSIONS OF SODIUM ACETATE GIVEN TO VOLUNTEERS, AT 4 MMOL/KG/HR INCR PLASMA ACETATE BY ONLY 0.41 MMOL/L, INDICATING A HIGH ACETATE METABOLIZING CAPACITY IN MAN.

KVEIM MH R ET AL; J OSLO CITY HOSP: 30 (8): 101 (1980)


Readily metabolized outside the liver.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 723


5.6 Mechanism of Action

It works as a source of sodium ions especially in cases of hyponatremic patients. Sodium has a primary role in regulating extracellular fluid volume. It controls water distribution, fluid and electrolyte balance and the osmotic pressure of body fluids. Sodium is also involved in nerve conduction, muscle contraction, acid-base balance and cell nutrient uptake.


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ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"SODIUM ACETATE TRIHYDRATE EMPROVE EXPERT PH EUR,BP,CHP,JP,USP 16PCS X 25KG (PHARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"2045.7","totalValueFC":"9720.8","currency":"INR","unitRateINR":"2050.8","date":"25-Nov-2024","totalValueINR":"820321.05","totalValueInUsd":"9720.8","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"6864867","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"SODIUM ACETATE ANHYDROUS(AS PER INVOICE NO.LRS2024110501712\/CI)CHEMICAL","address":"2ND FLOOR, SERENE CHAMBERS,","city":"","supplier":"SAINTSUN PHARMA","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LAURUS LABS","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"1.7","totalValueFC":"3507.9","currency":"USD","unitRateINR":"149","date":"07-Dec-2024","totalValueINR":"298062","totalValueInUsd":"3507.9","indian_port":"Madras Sea","hs_no":"29152990","bill_no":"7112979","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 202 FLOOR 2 BUILDING 7 YARD 18 JINGXING ST INDUS BASE EAST AREA SCIENCE & TECH PARK CHANGPING DT CN","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735151400,"product":"SODIUM ACETATE USP (PHARMA GRADE FOR PHARMACEUTICALS USE ONLY)SODIUM ACETATE USP AGGLO20 KG BG","address":"306, STUDIO COMPLEX, NEAR GOTA CHAR","city":"AHMEDABAD -","supplier":"MACCO ORGANIQUES INC","supplierCountry":"CANADA","foreign_port":"MONTREAL-DORAVAL APT","customer":"TEKNIRVANA TRADELINK PRIVATE ","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"12.6","totalValueFC":"14907","currency":"USD","unitRateINR":"1266.6","date":"26-Dec-2024","totalValueINR":"1266632.84","totalValueInUsd":"14907","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"7456240","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL-DORAVAL APT","supplierAddress":"100,RUE MCAARTHUR,SOITE 112 VALLEYF IELD(QUEBEC) 365 4M5 Valleyfield, , Canada 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M-14 TO M-18,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"SODIUM ACETATE TRIHYDRATE EXTRA PURE EMPROVE ESSENTIAL PH EUR,BP,JP,USP,FCC,E 262 5PCS X 25KG (PHARMA GRADE)ORGANIC CHEMICALS","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"NETHERLANDS","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"23.7","totalValueFC":"2986.5","currency":"INR","unitRateINR":"2060.2","date":"17-Jan-2025","totalValueINR":"257520.95","totalValueInUsd":"2986.5","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"7838701","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY 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04-Jan-2021
28-Feb-2025
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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3M...DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

USFDA APPLICATION NUMBER - 20742

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ABOUT THIS PAGE

Looking for 127-09-3 / Sodium Acetate API manufacturers, exporters & distributors?

Sodium Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sodium Acetate

Synonyms

127-09-3, Acetic acid, sodium salt, Sodium acetate anhydrous, Acetic acid sodium salt, Sodium acetate, anhydrous, Anhydrous sodium acetate

Cas Number

127-09-3

Unique Ingredient Identifier (UNII)

NVG71ZZ7P0

About Sodium Acetate

The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.

Sodium acetate anhydrous Manufacturers

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

Sodium acetate anhydrous Suppliers

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

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

Sodium acetate anhydrous USDMF

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

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

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

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

Sodium acetate anhydrous WC

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

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

Sodium acetate anhydrous 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 Sodium acetate anhydrous as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sodium acetate anhydrous GMP

Sodium acetate anhydrous 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 Sodium acetate anhydrous 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 Sodium acetate anhydrous GMP manufacturer or Sodium acetate anhydrous GMP API supplier for your needs.

Sodium acetate anhydrous CoA

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

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

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