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    Chemistry

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    Also known as: Proguanil hydrochloride, Chloroguanide hydrochloride, 637-32-1, Diguanyl, Chlorguanide hydrochloride, Chloroquanil
    Molecular Formula
    C11H17Cl2N5
    Molecular Weight
    290.19  g/mol
    InChI Key
    SARMGXPVOFNNNG-UHFFFAOYSA-N
    FDA UNII
    R71Y86M0WT
    Proguanil
    A biguanide compound which metabolizes in the body to form cycloguanil, an anti-malaria agent.
    1 2D Structure

    Proguanil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1E)-1-[amino-(4-chloroanilino)methylidene]-2-propan-2-ylguanidine;hydrochloride
    2.1.2 InChI
    InChI=1S/C11H16ClN5.ClH/c1-7(2)15-10(13)17-11(14)16-9-5-3-8(12)4-6-9;/h3-7H,1-2H3,(H5,13,14,15,16,17);1H
    2.1.3 InChI Key
    SARMGXPVOFNNNG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)N=C(N)N=C(N)NC1=CC=C(C=C1)Cl.Cl
    2.1.5 Isomeric SMILES
    CC(C)N=C(N)/N=C(\N)/NC1=CC=C(C=C1)Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    R71Y86M0WT
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bigumal

    2. Chlorguanid

    3. Chloriguane

    4. Chloroguanide

    5. Chloroguanide Hydrochloride

    6. Hydrochloride, Chloroguanide

    7. Hydrochloride, Proguanil

    8. Paludrin

    9. Proguanil

    10. Proguanil Hydrochloride

    2.3.2 Depositor-Supplied Synonyms

    1. Proguanil Hydrochloride

    2. Chloroguanide Hydrochloride

    3. 637-32-1

    4. Diguanyl

    5. Chlorguanide Hydrochloride

    6. Chloroquanil

    7. Proguanil Hcl

    8. Proguanilhydrochloride

    9. 1-(p-chlorophenyl)-5-isopropylbiguanide Hydrochloride

    10. Drinupal

    11. Guanatol

    12. Palusil

    13. Gw Ah7673a

    14. Tirian Hydrochloride

    15. Proguanil (hydrochloride)

    16. 336u50

    17. Palusil Hydrochloride

    18. Drinupal Hydrochloride

    19. Guanatol Hydrochloride

    20. Gwah7673a

    21. Gw-ah7673a

    22. R71y86m0wt

    23. M-4888

    24. Nsc-12977

    25. Nsc-26614

    26. Rp-3359

    27. Bigumalum

    28. Sn-12837

    29. 3359 Rp

    30. Dsstox_cid_27756

    31. Dsstox_rid_82533

    32. Dsstox_gsid_47776

    33. 336-u-50

    34. Sn 12,837

    35. 1-(4-chlorophenyl)-5-isopropylbiguanide Hydrochloride

    36. M 4888

    37. Chloroguanidine Hydrochloride

    38. Imidodicarbonimidic Diamide, N-(4-chlorophenyl)-n'-(1-methylethyl)-,monohydrochloride

    39. N-(4-chlorophenyl)-n(sup5)-isopropyldiguanide Hydrochloride

    40. Ncgc00016528-01

    41. Cas-637-32-1

    42. Einecs 211-283-7

    43. Nsc 12977

    44. Nsc 26614

    45. Unii-r71y86m0wt

    46. Sr-05000001973

    47. Proguanil Hydrochloride [usan]

    48. 1-(4-chlorophenyl)-3-(n-propan-2-ylcarbamimidoyl)guanidine;hydrochloride

    49. Proguanil Chloride

    50. Paludrine (tn)

    51. Proguanil Hydrochloride [usan:usp]

    52. N-4-chlorophenyl-n(sup 5)-isopropyldiguanide Hydrochloride

    53. Proguanili Hydrochloridum

    54. Biguanide, 1-(p-chlorophenyl)-5-isopropyl-, Monohydrochloride

    55. Imidodicarbonimidic Diamide, N-(4-chlorophenyl)-n'-(1-methylethyl)-, Monohydrochloride

    56. Schembl218859

    57. Ambz0378

    58. Proguanil For System Suitability

    59. Chembl1201059

    60. Dtxsid7047776

    61. Hy-b0806a

    62. Hms1571g19

    63. Pharmakon1600-01504211

    64. Proguanil Hydrochloride (jan/usp)

    65. Tox21_110476

    66. Ccg-39555

    67. Nsc758688

    68. Proguanil Hydrochloride [jan]

    69. Akos024255720

    70. Tox21_110476_1

    71. Am85857

    72. Chlorguanide Hydrochloride [mi]

    73. Hs-0102

    74. Nsc-758688

    75. Proguanil Hydrochloride [mart.]

    76. Proguanil Hydrochloride [usp-rs]

    77. Proguanil Hydrochloride [who-dd]

    78. Proguanil Hydrochloride [who-ip]

    79. Ncgc00016528-05

    80. Proguanil Hydrochloride, >=95% (hplc)

    81. Cs-0031267

    82. Proguanil Hydrochloride [orange Book]

    83. Proguanil Hydrochloride [ep Monograph]

    84. D02487

    85. Proguanil Hydrochloride [usp Monograph]

    86. Malarone Component Proguanil Hydrochloride

    87. Proguanili Hydrochloridum [who-ip Latin]

    88. 637p321

    89. A923181

    90. Proguanil Hydrochloride Component Of Malarone

    91. Sr-05000001973-3

    92. W-109585

    93. Malarone Pediatric Component Proguanil Hydrochloride

    94. Proguanil Hydrochloride Component Of Malarone Pediatric

    95. 1-(p-chlorophenyl)-5-isopropylbiguanide Monohydrochloride

    96. Proguanil Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    97. Proguanil Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    98. Proguanil Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    99. (1e)-1-[amino-[(4-chlorophenyl)amino]methylidene]-2-propan-2-ylguanidine Hydrochloride

    100. Proguanil For System Suitability, European Pharmacopoeia (ep) Reference Standard

    101. Proguanil Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    102. Imidodicarbonimidic Diamide, N-(4-chlorophenyl)-n'-(1-methylethyl)-, Hydrochloride (1:1)

    2.4 Create Date
    2006-10-24
    3 Chemical and Physical Properties
    Molecular Weight 290.19 g/mol
    Molecular Formula C11H17Cl2N5
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count4
    Exact Mass289.0861010 g/mol
    Monoisotopic Mass289.0861010 g/mol
    Topological Polar Surface Area88.8 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity292
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Antimalarials

    Agents used in the treatment of malaria. They are usually classified on the basis of their action against plasmodia at different stages in their life cycle in the human. (From AMA, Drug Evaluations Annual, 1992, p1585) (See all compounds classified as Antimalarials.)

    Antimetabolites

    Drugs that are chemically similar to naturally occurring metabolites, but differ enough to interfere with normal metabolic pathways. (From AMA Drug Evaluations Annual, 1994, p2033) (See all compounds classified as Antimetabolites.)

    API Reference Price

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    11-Nov-2022
    01-Apr-2024
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    DOSAGE - TABLET;ORAL - 250MG;100MG

    USFDA APPLICATION NUMBER - 21078

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    DOSAGE - TABLET;ORAL - 62.5MG;25MG

    USFDA APPLICATION NUMBER - 21078

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    USP

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    ABOUT THIS PAGE

    Proguanil Manufacturers

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

    Proguanil Suppliers

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

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

    Proguanil USDMF

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

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

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    Proguanil CEP

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

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

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    Proguanil WC

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

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    Proguanil 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 Proguanil as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Proguanil GMP

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

    Proguanil CoA

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

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

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