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    Chemistry

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    Also known as: 7757-82-6, Disodium sulfate, Sodium sulfate, anhydrous, Sodium sulfate anhydrous, Sodium sulphate, Salt cake
    Molecular Formula
    Na2O4S
    Molecular Weight
    142.04  g/mol
    InChI Key
    PMZURENOXWZQFD-UHFFFAOYSA-L
    FDA UNII
    36KCS0R750
    Sodium Sulfate
    Sodium Sulfate Anhydrous is the anhydrous, sodium salt form of sulfuric acid. Sodium sulfate anhydrous disassociates in water to provide sodium ions and sulfate ions. Sodium ion is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Sodium sulfate anhydrous is an electrolyte replenisher and is used in isosmotic solutions so that administration does not disturb normal electrolyte balance and does not lead to absorption or excretion of water and ions.
    1 2D Structure

    Sodium Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    disodium;sulfate
    2.1.2 InChI
    InChI=1S/2Na.H2O4S/c;;1-5(2,3)4/h;;(H2,1,2,3,4)/q2*+1;/p-2
    2.1.3 InChI Key
    PMZURENOXWZQFD-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    [O-]S(=O)(=O)[O-].[Na+].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    36KCS0R750
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Disodium Sulfate

    2. Mangxiao

    3. Mirabilitum

    4. Natrii Sulphas

    5. Puxiao

    6. Sodium Bisulfate

    7. Sodium Bisulfate, Monohydrate

    8. Sodium Hydrosulfate

    9. Sodium Sulfate, 35s-labeled Cpd

    10. Sodium Sulfate, Decahydrate

    11. Sulfuric Acid, Monosodium Salt

    12. Thenardite

    2.3.2 Depositor-Supplied Synonyms

    1. 7757-82-6

    2. Disodium Sulfate

    3. Sodium Sulfate, Anhydrous

    4. Sodium Sulfate Anhydrous

    5. Sodium Sulphate

    6. Salt Cake

    7. Sodiumsulfate

    8. Sulfuric Acid Disodium Salt

    9. Disodium Sulphate

    10. Disodium;sulfate

    11. 15124-09-1

    12. Sulfuric Acid, Sodium Salt

    13. Sulfate, Sodium

    14. Sodium Sulphate Anhydrous

    15. Sodium Sulfate, Dried [jan]

    16. Sodium Sulfate, Dried

    17. Na2so4

    18. Mfcd00003504

    19. Sodium Sulphate, Anhydrous

    20. Chebi:32149

    21. 36kcs0r750

    22. Nsc-403914

    23. Sulfuric Acid, Mono-c14-18-alkyl Esters, Sodium Salts

    24. 13759-07-4

    25. Sodium Sulfate, Dried (jan)

    26. Dibasic Sodium Sulfate

    27. Natriumsulfat (german)

    28. Na Sulphate

    29. Caswell No. 793

    30. Hsdb 5042

    31. Sodium Sulfate Anyhdrous

    32. Sulfuric Acid Sodium Salt (1:2)

    33. Sodium Sulfate (solution)

    34. Thenardite (na2(so4))

    35. Natriumsulfat

    36. Sodium Tallow Alcohol Sulfate

    37. Unii-36kcs0r750

    38. Einecs 231-820-9

    39. Einecs 268-366-6

    40. Einecs 268-773-9

    41. Einecs 270-211-2

    42. Epa Pesticide Chemical Code 005604

    43. Nsc 403914

    44. Sodium Sulfate Acs He

    45. Ai3-02398

    46. Sda 17-062-04

    47. Sulfuric Acid Sodium Salt

    48. Dsstox_cid_1291

    49. Ec 231-820-9

    50. Dsstox_rid_76063

    51. Sodium Sulfate [mi]

    52. Dsstox_gsid_21291

    53. Sodium Sulfate, Acs Reagent

    54. Sodium Sulfate, Dried (tn)

    55. Sodium Sulfate [hsdb]

    56. Chembl233406

    57. Dtxsid1021291

    58. Anhydous Sodium Sulfate (jp17)

    59. Sodium Sulfate - Drilling Grade

    60. Bcp13313

    61. Sodium Sulfate, For Residue Analysis

    62. Tox21_201045

    63. Sodium Sulfate Anhydrous [ii]

    64. Akos015833463

    65. Anhydrous Sodium Sulfate [jan]

    66. Sodium Sulfate Anhydrous Granular Acs

    67. Sodium Sulfate, Bioxtra, >=99.0%

    68. Sulfuric Acid Disodium Salt, Anhydrous

    69. Db09472

    70. Anhydrous Sodium Sulfate [mart.]

    71. Ncgc00258598-01

    72. Sodium Sulfate, Lr, Anhydrous, >=99%

    73. E514

    74. Sodium Sulfate Anhydrous [usp-rs]

    75. Sodium Sulfate Anhydrous [who-dd]

    76. Sodium Sulfate Anhydrous; Sodium Sulphate

    77. Cas-7757-82-6

    78. Sodium Sulfate, Anhydrous [who-ip]

    79. Sodium Sulfate, Ar, Anhydrous, >=99.5%

    80. Ft-0645112

    81. S0566

    82. Sodium Sulfate, 99.9955% (metals Basis)

    83. Sodium Sulfate, Reagentplus(r), >=99.0%

    84. Sodium Sulfate Anhydrous [orange Book]

    85. Sodium Sulfate, For Pesticide Residue Analysis

    86. Sodium Sulfate, Trace Metals Grade, 99.99%

    87. D01732

    88. Natrii Sulfas Anhydricus [who-ip Latin]

    89. Sodium Sulfate, >=99.99% Trace Metals Basis

    90. Sodium Sulfate, Jis Special Grade, >=99.0%

    91. Sodium Sulfate, Vetec(tm) Reagent Grade, 99%

    92. Sodium Sulfate Anhydrous [usp Monograph]

    93. Sodium Sulfate, Anhydrous [ep Monograph]

    94. Sodium Sulfate, Meets Usp Testing Specifications

    95. Q211737

    96. Sodium Sulfate, For Hplc, 99.0-101.0% (t)

    97. Sodium Sulfate, Purum, Anhydrous, >=99.0% (t)

    98. Sodium Sulfate, Saj First Grade, >=99.0%, Beads

    99. Sodium Sulfate, Saj First Grade, >=99.0%, Powder

    100. Sodium Sulfate, >=99.0%, Plant Cell Culture Tested

    101. Sodium Sulfate, Bioultra, Anhydrous, >=99.0% (t)

    102. Sodium Sulfate, P.a., 99.0-101.0%, Reag. Iso

    103. Sodium Sulfate, For Pesticide Residue Analysis, 99.0%

    104. Sodium Sulfate, Tested According To Ph.eur., Anhydrous

    105. Sulfuric Acid Disodium Salt, Anhydrous [who-ip]

    106. Sodium Sulfate, Acs Reagent, >=99.0%, Anhydrous, Powder

    107. Sodium Sulfate, Acs Reagent, >=99.0%, Anhydrous, Granular

    108. Sodium Sulfate, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99%

    109. Sodium Sulfate Anhydrous, United States Pharmacopeia (usp) Reference Standard

    110. Sodium Sulfate, Anhydrous, Free-flowing, Redi-dri(tm), Reagentplus(r), >=99%

    111. Sodium Sulfate, Anhydrous, Granular, Free-flowing, Redi-dri(tm), Acs Reagent, >=99%

    112. Sodium Sulfate, Puriss. P.a., Acs Reagent, Reag. Iso, Reag. Ph. Eur., Anhydrous, >=99.0%

    113. Sodium Sulfate, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Usp, Anhydrous, 99.0-100.5% (calc. To The Dried Substance)

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 142.04 g/mol
    Molecular Formula Na2O4S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass141.93126821 g/mol
    Monoisotopic Mass141.93126821 g/mol
    Topological Polar Surface Area88.6 Ų
    Heavy Atom Count7
    Formal Charge0
    Complexity62.2
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Cathartics

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

    EXPL THER /The purpose of the study was/ to evaluate the early bone response to a nanotextured dental implant treated with sodium sulfate (Na2SO4), using a rabbit model. Twelve animals were randomly divided into group 1 (Control) - machined implants and group 2 (Test) - nanotextured implants. Extra-oral incision was performed to provide access to intended surgical site where the dental implant was inserted immediately after the extraction of the mandibular first premolar. Implant surface characterization was performed by scanning electron microscopy attached to energy dispersive spectroscopy and interferometry. Three weeks after surgery, the animals were induced to death and undecalcified sections of the samples were prepared for histological and histomorphometrical analysis. Surface characterization of the implant demonstrated enhanced surface area of anodized group compared to Control group with 19.2% +/- 6.2 versus 1.6 +/- 0.7, respectively. Histological evaluation demonstrated new bone formation starting from the buccal and lingual cortical walls on both groups. After three weeks, significant higher bone contact of 27% (p<0.05) was observed to nanotextured compared to machined implants (Control group). The anodization with sodium sulfate nanostructures to the implant surface that resulted in faster osseointegration.

    PMID:24919046 Pinheiro FA et al; Acta Cir Bras 29 (6): 376-82 (2014)

    /EXPL THER/ ... 2-16 mmol/kg of sodium sulfate and sulfur-containing amino acids (cysteine or methionine) were infused intravenously for 2 hr into pentobarbital-anesthetized rats. ... Hepatic 3'-phosphoadenosine 5'-phosphosulfate concentrations increased significantly (30-35%) only when infused with the higher doses (8 or 16 mmol/kg/2 hr) of sodium sulfate.

    PMID:7493551 Kim HJ et al; Drug Metab Dispos 23 (8): 840-5 (1995)

    VET: Cathartic

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 1607

    For more Therapeutic Uses (Complete) data for Sodium sulfate (12 total), please visit the HSDB record page.

    4.2 Drug Warning

    Sodium sulfate used in treatment of hypercalcemia may result in hypokalemia and hypernatremia. Thus, the progress of patients with cardiovascular disease should be watched closely when ... infusions are administered.

    Hansten, P.D. Drug Interactions. 4th ed. Philadelphia: Lea and Febiger, 1979., p. 396

    4.3 Drug Indication

    indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Induces catharsis by the osmotic effects of the unabsorbed sulfate salts and polyethylene glycol (PEG) in the GI tract. Specifically, sulfate salts provide sulfate anions, which are poorly absorbed, and PEG, which is primarily unabsorbed, causes water to be retained in the GI tract resulting in watery diarrhea.

    5.2 MeSH Pharmacological Classification

    Cathartics

    Agents that are used to stimulate evacuation of the bowels. (See all compounds classified as Cathartics.)

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

    A - Alimentary tract and metabolism

    A06 - Drugs for constipation

    A06A - Drugs for constipation

    A06AD - Osmotically acting laxatives

    A06AD13 - Sodium sulfate

    A - Alimentary tract and metabolism

    A12 - Mineral supplements

    A12C - Other mineral supplements

    A12CA - Sodium

    A12CA02 - Sodium sulfate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Absorption of sodium sulfate after ingestion in rats was investigated. 35)S-Radioactivity excreted in urine during 24 hr indicated almost complete absorption from GI tract. Determination in serum 2 hr after admin revealed 3-fold increase in sulfate concentration rapid and almost complete absorption of inorganic sulfate occurs after oral admin in rats.

    Route of Elimination

    Rectal effluent if unabsorbed sulfates ; urine (predominant route for absorbed sulfates )

    The importance of tissue sulfate concentrations in regulating 3'-phosphoadenosine 5'-phosphosulfate (PAPS) synthesis is not known. Therefore, this study was conducted to determine the influence of increased availability of inorganic sulfate on steady-state PAPS concentrations in various tissues. To increase tissue sulfate concentrations, 2-16 mmol/kg of sodium sulfate and sulfur-containing amino acids (cysteine or methionine) were infused intravenously for 2 hr into pentobarbital-anesthetized rats. Serial blood samples were taken during the infusion and analyzed for sulfate concentrations. After 2 hr of infusion, liver, kidney, and brain were removed for quantification of tissue PAPS and sulfate concentrations. Infusion of sodium sulfate, cysteine, and methionine increased serum and tissue sulfate concentrations in a dose- and time-dependent manner. Serum sulfate concentrations increased from 0.8 to 14 mM during the infusion of sodium sulfate, whereas infusions of cysteine and methionine increased serum sulfate concentrations to 4.8 and 2.0 mM, respectively. Tissue sulfate concentrations also increased during sulfate infusion. Liver sulfate concentration increased from 0.8 to 4.8 mM, kidney concentration increased from 0.6 to 31 mM, and brain concentration increased from 0.1 to 0.6 mM. Similar to the serum sulfate concentrations, sulfate infusion was the most effective in increasing tissue sulfate concentrations, cysteine was intermediate, and methionine the least effective. Although sulfate concentrations in liver, kidney, and brain increased 6-, 50-, and 6-fold by infusing sulfate, respectively; tissue PAPS levels were not altered markedly. Hepatic PAPS concentrations increased significantly (30-35%) only when infused with the higher doses (8 or 16 mmol/kg/2 hr) of sodium sulfate.

    PMID:7493551 Kim HJ et al; Drug Metab Dispos 23 (8): 840-5 (1995)

    The absorption of inorganic sulfate after ingestion was investigated in rats. After oral administration of Na235SO4, 35S radioactivity was measurable in plasma already after 15 min and its plasma concentration reached a peak after about 1.5-2 hr. The 35S-radioactivity excreted in urine during 24 hr after ingestion of Na235SO4 together with varying amounts of unlabelled Na2SO4 (0.25-5.0 mmol Na2SO4 per rat) indicated an almost complete absorption of inorganic sulfate from the gastrointestinal tract. Determination of the inorganic sulfate concentration in rat serum 2 hr after oral administration of 5.0 mmol Na2SO4 revealed a three-fold increase in serum sulfate concentration. The data suggest a rapid and almost complete absorption of inorganic sulfate after oral administration in the rat. Its importance in relation to the sulfate availability for sulfate conjugation of drugs is discussed.

    PMID:476150 Krijgsheld KR et al; Biochim Biophys Acta 586 (3): 492-500 (1979)

    Sodium sulfate can be used to enhance the conjugation of phenolic drugs with sulfate and to treat hypercalcemia. It is thought that sulfate in is absorbed slowly and incompletely from the digestive tract. The purposes of this investigation were to determine the absorption of large amount of sodium sulfate(18.1 g as the decahydrate, equivalent to 8.0 g of the anhydrous salt) and to compare the bioavailability when this amount is administered orally to normal subjects as a single dose and as four equally divided hourly doses. The 72-hr urinary recovery of free sulfate following single and divided doses was 53.4 +/- 15.8 and 61.8 +/- 7.8%, respectively (mean +/- SD, n=5, p > 0.2). The single dose produced severe diarrhea while the divided doses caused only mild or no diarrhea. Thus, a large amount of sodium sulfate, when administered orally in divided doses over 3 hr, is well tolerated and is absorbed to a significant extent. Orally administered sodium sulfate may be useful for the early treatment of acetaminophen overdose.

    PMID:7264905 Cocchetto DM, Levy G; J Pharm Sci 70 (3): 331-3 (1981)

    The renal excretion of potassium by unanesthetized sheep was studied in clearance studies in which water and sodium excretion were elevated by intravenous infusion of isotonic sodium chloride, hypertonic sodium phosphate, or hypertonic sodium sulfate. Aldosterone was infused at 10 ug/hr in some experiments with sodium sulfate. Sodium excretion increased in all experiments, rising at times to equal 25% of the filtered load. Urine flow increased in most experiments. Glomerular filtration rate increased only with infusion of isotonic saline. No consistent change in potassium excretion occurred under any of these loading conditions. This finding contrasts with the increase in potassium excretion commonly seen in man, dogs, and rats intravenously loaded with sodium salts.

    PMID:645906 Rabinowitz L, Gunther RA; Am J Physiol 234 (5): F371-5 (1978)

    5.6 Biological Half-Life

    Serum sulfate: 8.5 hours

    5.7 Mechanism of Action

    MoviPrep produces a watery stool leading to cleansing of the colon. The osmotic activity of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, when taken with 1 liter of additional clear fluid, usually results in no net absorption or excretion of ions or water.

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    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21560

    Submission : 2008-04-22

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Hunan Warrant Chiral Pharmaceutica...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    10

    Brenntag

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    Brenntag

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663439400,"product":"EQUILENIN SODIUM SULFATE (SAMPLEFOR RESEARCH AND ANALYSIS, FOC )","address":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL","city":"MEDCHAL-MALKAKGIRI DISTRICT,TELANGA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"NA","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"20","totalValueFC":"100.8","currency":"EUR","unitRateINR":"1616","date":"18-Sep-2022","totalValueINR":"8080","totalValueInUsd":"100.8","indian_port":"HYDERABAD AIR","hs_no":"29372300","bill_no":"2496310","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705429800,"product":"17 ALPHA ESTRADIOL SODIUM SULFATE (SAMPLE FOR RESEARCH AND ANALYSIS, FOC )","address":"ASURVEY NO.225, SAMPANBOLE VILLAGE","city":"","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"33.3","totalValueFC":"111.5","currency":"EUR","unitRateINR":"3090","date":"17-Jan-2024","totalValueINR":"9270","totalValueInUsd":"111.5","indian_port":"Hyderabad Air","hs_no":"29372300","bill_no":"9695680","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"NETHERLANDSSDNFSDNF NL","customerAddress":"ASURVEY NO.225, SAMPANBOLE VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705429800,"product":"DELTA 8 9 DEHYDRO ESTRONE SODIUM SULFATE (SAMPLE FOR RESEARCH AND ANALYSIS, FOC )","address":"ASURVEY NO.225, SAMPANBOLE VILLAGE","city":"","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"33.3","totalValueFC":"111.5","currency":"EUR","unitRateINR":"3090","date":"17-Jan-2024","totalValueINR":"9270","totalValueInUsd":"111.5","indian_port":"Hyderabad Air","hs_no":"29372300","bill_no":"9695680","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"NETHERLANDSSDNFSDNF NL","customerAddress":"ASURVEY NO.225, SAMPANBOLE VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705429800,"product":"EQUILENIN SODIUM SULFATE (SAMPLE FOR RESEARCH AND ANALYSIS,FOC )","address":"ASURVEY NO.225, SAMPANBOLE VILLAGE","city":"","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"200","totalValueFC":"111.5","currency":"EUR","unitRateINR":"18540","date":"17-Jan-2024","totalValueINR":"9270","totalValueInUsd":"111.5","indian_port":"Hyderabad Air","hs_no":"29372300","bill_no":"9695680","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"NETHERLANDSSDNFSDNF NL","customerAddress":"ASURVEY NO.225, SAMPANBOLE VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705429800,"product":"EQUILIN SODIUM SULFATE (SAMPLE FOR RESEARCH AND ANALYSIS, FOC )","address":"ASURVEY NO.225, SAMPANBOLE VILLAGE","city":"","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"33.3","totalValueFC":"111.5","currency":"EUR","unitRateINR":"3090","date":"17-Jan-2024","totalValueINR":"9270","totalValueInUsd":"111.5","indian_port":"Hyderabad Air","hs_no":"29372300","bill_no":"9695680","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"NETHERLANDSSDNFSDNF NL","customerAddress":"ASURVEY NO.225, SAMPANBOLE VILLAGE"}]
    18-Sep-2022
    17-Jan-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;1...DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

    USFDA APPLICATION NUMBER - 204553

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    DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479G...DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479GM

    USFDA APPLICATION NUMBER - 213135

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    ABOUT THIS PAGE

    Sodium Sulfate Manufacturers

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

    Sodium Sulfate Suppliers

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

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

    Sodium Sulfate USDMF

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

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

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

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

    Sodium Sulfate CEP

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

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

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

    Finished drug products

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

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

    Sodium Sulfate GMP

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

    Sodium Sulfate CoA

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

    Sodium Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Sulfate 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 Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Sulfate EP), Sodium Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Sulfate 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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