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    Chemistry

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    Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect
    Molecular Formula
    C23H35NaO7
    Molecular Weight
    446.5  g/mol
    InChI Key
    VWBQYTRBTXKKOG-IYNICTALSA-M
    FDA UNII
    3M8608UQ61
    Pravastatin
    An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).
    1 2D Structure

    Pravastatin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
    2.1.2 InChI
    InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14-,16+,17+,18+,19-,20-,22-;/m0./s1
    2.1.3 InChI Key
    VWBQYTRBTXKKOG-IYNICTALSA-M
    2.1.4 Canonical SMILES
    CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[Na+]
    2.1.5 Isomeric SMILES
    CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)[O-])O)O)O.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    3M8608UQ61
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Apo Pravastatin

    2. Apo-pravastatin

    3. Bristacol

    4. Cs 514

    5. Cs-514

    6. Cs514

    7. Elisor

    8. Eptastatin

    9. Lin Pravastatin

    10. Lin-pravastatin

    11. Lipemol

    12. Liplat

    13. Lipostat

    14. Mevalotin

    15. Nu Pravastatin

    16. Nu-pravastatin

    17. Prareduct

    18. Pravachol

    19. Pravacol

    20. Pravasin

    21. Pravastatin

    22. Pravastatin Monosodium Salt, (6 Beta)-isomer

    23. Pravastatin Sodium Salt

    24. Pravastatin Tert Octylamine Salt

    25. Pravastatin Tert-octylamine Salt

    26. Pravastatin, (6 Beta)-isomer

    27. Rms 431

    28. Rms-431

    29. Rms431

    30. Selektine

    31. Sodium Salt, Pravastatin

    32. Sq 31,000

    33. Sq 31000

    34. Sq-31,000

    35. Sq-31000

    36. Sq31,000

    37. Sq31000

    38. Vasten

    2.3.2 Depositor-Supplied Synonyms

    1. 81131-70-6

    2. Pravachol

    3. Mevalotin

    4. Selektine

    5. Elisor

    6. Pravaselect

    7. Lipostat

    8. Eptastatin Sodium

    9. Cs-514

    10. Pravastatin Sodium Salt

    11. Pravastatin (sodium)

    12. Dehypotin Protect

    13. Sq-31000

    14. Sq-31,000

    15. Chebi:8361

    16. Bristacol

    17. Lipemol

    18. Prareduct

    19. Pravacol

    20. Pravasin

    21. 3m8608uq61

    22. Nsc-759253

    23. Sodium;(3r,5r)-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-[(2s)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

    24. Aplactin

    25. Lipidal

    26. Liprevil

    27. Pralidon

    28. Pravasine

    29. Sanaprav

    30. Selipran

    31. Vasen

    32. Epastatin Sodium

    33. Dsstox_cid_27525

    34. Dsstox_rid_82395

    35. Dsstox_gsid_47525

    36. Liplat

    37. Vasten

    38. Pravastatin, Sodium Salt

    39. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoic Acid, Sodium Salt

    40. Cas-81131-70-6

    41. Pravastatin Natrium Mayrho Fer

    42. Sq 31000

    43. 3-beta-hydroxycompactin Sodium Salt

    44. Drg-0319

    45. Chembl690

    46. Unii-3m8608uq61

    47. Cres Pravastatin

    48. Pravachol (tn)

    49. Ncgc00095183-01

    50. Pravastatin Sodium [usan:usp:jan]

    51. Mfcd00887601

    52. Pravastatinsodium,(s)

    53. Cs-514 Sodium

    54. Pravastatin Sodium- Bio-x

    55. Schembl3013

    56. Sodium (+)-(betar,deltar,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

    57. Pravastatin Sodium [mi]

    58. Dtxsid6047525

    59. Pravastatin Sodium [jan]

    60. Hy-b0165a

    61. Pravastatin Sodium (jp17/usp)

    62. Pravastatin Sodium [usan]

    63. Hms2051p05

    64. Hms3268l20

    65. Hms3413e20

    66. Pravastatin Sodium [vandf]

    67. Hexahydronaphthalen-1-yl)heptanoate

    68. Pravastatin Sodium [mart.]

    69. Amy40517

    70. Pravastatin Sodium [usp-rs]

    71. Pravastatin Sodium [who-dd]

    72. Tox21_111474

    73. Tox21_300270

    74. S3036

    75. Akos015896504

    76. Akos015964902

    77. Ccg-100926

    78. Cs-2003

    79. Nc00176

    80. Nsc 759253

    81. Pravastatin Sodium [orange Book]

    82. Ncgc00092370-01

    83. Ncgc00254232-01

    84. Pravastatin Sodium [ep Monograph]

    85. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, Monosodium Salt, (1s-(1-alpha(beta-s*,delta-s*),2-alpha,6-alpha,8-beta(r*),8a-alpha))-

    86. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1alpha(betas*,deltas*),2alpha,6alpha,8beta(r*),8aalpha))-

    87. Bp164292

    88. Pravastatin Sodium [usp Monograph]

    89. P1796

    90. D00893

    91. Pravigard Pac Component Pravastatin Sodium

    92. Pravastatin Sodium Component Of Pravigard Pac

    93. Q27108059

    94. Pravastatin Sodium Salt Hydrate, >=98% (hplc), Powder

    95. 2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-

    96. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-

    97. (?r,?r,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Monosodium Salt

    98. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoicacid,sodiumsalt

    99. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-.beta.,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1.alpha.(.beta.s*,ds*),2.alpha.,6.alpha.,8.beta.(r*),8a.alpha.))-

    100. Sodium (+)-(.beta.r,dr,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-.beta.,d,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

    101. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate

    102. Sodium (3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(2s)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate

    2.4 Create Date
    2007-11-09
    3 Chemical and Physical Properties
    Molecular Weight 446.5 g/mol
    Molecular Formula C23H35NaO7
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count11
    Exact Mass446.22804773 g/mol
    Monoisotopic Mass446.22804773 g/mol
    Topological Polar Surface Area127 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity662
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    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 4  
    Drug NamePravachol
    PubMed HealthPravastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelPRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
    Active IngredientPravastatin sodium
    Dosage FormTablet
    RouteOral
    Strength10mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanyBristol Myers Squibb

    2 of 4  
    Drug NamePravastatin sodium
    Drug LabelPravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
    Active IngredientPravastatin sodium
    Dosage FormTablet
    Routeoral; Oral
    Strength10mg; 80mg; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

    3 of 4  
    Drug NamePravachol
    PubMed HealthPravastatin (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelPRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
    Active IngredientPravastatin sodium
    Dosage FormTablet
    RouteOral
    Strength10mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanyBristol Myers Squibb

    4 of 4  
    Drug NamePravastatin sodium
    Drug LabelPravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
    Active IngredientPravastatin sodium
    Dosage FormTablet
    Routeoral; Oral
    Strength10mg; 80mg; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anticholesteremic Agents

    Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

    Hydroxymethylglutaryl-CoA Reductase Inhibitors

    Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

    API Reference Price

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    03-Feb-2021
    04-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19898

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    DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19898

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    DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19898

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    DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19898

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    USP

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    ABOUT THIS PAGE

    Pravastatin Sodium Manufacturers

    A Pravastatin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pravastatin Sodium, including repackagers and relabelers. The FDA regulates Pravastatin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pravastatin Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Pravastatin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pravastatin Sodium Suppliers

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

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

    Pravastatin Sodium USDMF

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

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

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

    Pravastatin Sodium JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Pravastatin Sodium Drug Master File in Japan (Pravastatin Sodium JDMF) empowers Pravastatin Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Pravastatin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Pravastatin Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Pravastatin Sodium suppliers with JDMF on PharmaCompass.

    Pravastatin Sodium KDMF

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

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

    After submitting a Pravastatin Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pravastatin Sodium API can apply through the Korea Drug Master File (KDMF).

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

    Pravastatin Sodium CEP

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

    A Pravastatin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pravastatin Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Pravastatin Sodium suppliers with CEP (COS) on PharmaCompass.

    Pravastatin Sodium WC

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

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

    Pravastatin Sodium NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pravastatin Sodium as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pravastatin Sodium API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Pravastatin Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Pravastatin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pravastatin Sodium NDC to their finished compounded human drug products, they may choose to do so.

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

    Pravastatin Sodium GMP

    Pravastatin Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Pravastatin Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pravastatin Sodium GMP manufacturer or Pravastatin Sodium GMP API supplier for your needs.

    Pravastatin Sodium CoA

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

    Pravastatin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Pravastatin Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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