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    Chemistry

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    Also known as: Chlorhexidine digluconate, Hibiclens, 18472-51-0, Peridex, Dyna-hex, Bioscrub
    Molecular Formula
    C34H54Cl2N10O14
    Molecular Weight
    897.8  g/mol
    InChI Key
    YZIYKJHYYHPJIB-UUPCJSQJSA-N
    FDA UNII
    MOR84MUD8E
    Chlorhexidine Gluconate
    Chlorhexidine Gluconate is the gluconate salt form of chlorhexidine, a biguanide compound used as an antiseptic agent with topical antibacterial activity. Chlorhexidine gluconate is positively charged and reacts with the negatively charged microbial cell surface, thereby destroying the integrity of the cell membrane. Subsequently, chlorhexidine gluconate penetrates into the cell and causes leakage of intracellular components leading to cell death. Since gram positive bacteria are more negatively charged, they are more sensitive to this agent.
    1 2D Structure

    Chlorhexidine Gluconate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid
    2.1.2 InChI
    InChI=1S/C22H30Cl2N10.2C6H12O7/c23-15-5-9-17(10-6-15)31-21(27)33-19(25)29-13-3-1-2-4-14-30-20(26)34-22(28)32-18-11-7-16(24)8-12-18;2*7-1-2(8)3(9)4(10)5(11)6(12)13/h5-12H,1-4,13-14H2,(H5,25,27,29,31,33)(H5,26,28,30,32,34);2*2-5,7-11H,1H2,(H,12,13)/t;2*2-,3-,4+,5-/m.11/s1
    2.1.3 InChI Key
    YZIYKJHYYHPJIB-UUPCJSQJSA-N
    2.1.4 Canonical SMILES
    C1=CC(=CC=C1NC(=NC(=NCCCCCCN=C(N)N=C(N)NC2=CC=C(C=C2)Cl)N)N)Cl.C(C(C(C(C(C(=O)O)O)O)O)O)O.C(C(C(C(C(C(=O)O)O)O)O)O)O
    2.1.5 Isomeric SMILES
    C1=CC(=CC=C1N/C(=N/C(=NCCCCCCN=C(/N=C(/NC2=CC=C(C=C2)Cl)\N)N)N)/N)Cl.C(O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(=O)O.C(O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    MOR84MUD8E
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1,1'-hbcb

    2. Avagard

    3. Chlorhexamed

    4. Chlorhexidine Bigluconate

    5. Chlorhexidine Digluconate

    6. Corsodyl Ici

    7. Curasept Ads 220

    8. Dyna-hex

    9. Eludril

    10. Gibitan

    11. Hexidine

    12. Hibiclens

    13. Hibident

    14. Hibiscrub

    15. Hibisol

    16. Hibitane

    17. Peridex

    18. Perio Chip

    2.3.2 Depositor-Supplied Synonyms

    1. Chlorhexidine Digluconate

    2. Hibiclens

    3. 18472-51-0

    4. Peridex

    5. Dyna-hex

    6. Bioscrub

    7. Chlorhexidine D-digluconate

    8. Exidine

    9. Microderm

    10. Periochip

    11. Periogard

    12. Unisept

    13. Brian Care

    14. Steri-stat

    15. Cida-stat

    16. Hibistat

    17. Pharmaseal Scrub Care

    18. Chg Scrub

    19. Prevacare

    20. Chlorhexidine Digluconate Solution

    21. Chlorhexidine Di-d-gluconate

    22. Mor84mud8e

    23. Nsc-753971

    24. Hibiscrub

    25. Hibitane

    26. 1,1'-hexamethylene Bis(5-(p-chlorophenyl)biguanide), Digluconate

    27. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide) Di-d-gluconate

    28. Bacticlens

    29. Chlorhexamed

    30. Kleersight

    31. Corsodyl

    32. Disteryl

    33. Hibident

    34. Hibidil

    35. Orahexal

    36. Plurexid

    37. Septeal

    38. Abacil

    39. Fight Bac

    40. Plac Out

    41. Prevacare R

    42. Arlacide G

    43. Hibitane 5

    44. 2,4,11,13-tetraazatetradecanediimidamide, N,n''-bis(4-chlorophenyl)-3,12-diimino-, Di-d-gluconate

    45. Chlorhexidin Glukonatu

    46. Peridex (antiseptic)

    47. Bactoshield Chg 2%

    48. Caswell No. 481g

    49. Unii-mor84mud8e

    50. Pwriochip

    51. Chlorhexidin Glukonatu [czech]

    52. 1,6-bis(n5-[p-chlorophenyl]-n1-biguanido)hexane

    53. Phiso-med

    54. Hibitane Gluconate

    55. Hibiclens (tn)

    56. Periogard (tn)

    57. Drg-0091

    58. Einecs 242-354-0

    59. Peridex (tn)

    60. Mfcd00083599

    61. Chlohexidine Gluconate

    62. Epa Pesticide Chemical Code 045504

    63. Readyprep Chg

    64. Chlorhexidine Gluconate [usan:usp:jan]

    65. Ec 242-354-0

    66. Schembl34468

    67. 1,6-bis(5-(p-chlorophenyl)biguandino)hexane Digluconate

    68. Chembl4297088

    69. Dtxsid5034519

    70. Chebi:28312

    71. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide) Gluconate

    72. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide)digluconate

    73. Chx Plus Concentrate Premium Chlorhexidine Teat Dip Concentrate

    74. Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, Digluconate

    75. Chlorhexidine Gluconate (jp17/usp)

    76. Chlorhexidine Gluconate [jan]

    77. Chlorhexidine Gluconate [usan]

    78. Akos015896303

    79. Akos025310696

    80. Chlorhexidine Gluconate [mart.]

    81. Chlorhexidine Gluconate [vandf]

    82. Nsc 753971

    83. Chlorhexidine D-digluconate [mi]

    84. Chlorhexidine Digluconate [inci]

    85. Chlorhexidine Gluconate [who-dd]

    86. Gluconic Acid, Compd. With 1,1'-hexamethylene Bis(5-(p-chlorophenyl)biguanide) (2:1), D-

    87. D-gluconic Acid, Compd. With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

    88. D-gluconic Acid, Compound With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

    89. Chlorhexidine Gluconate [orange Book]

    90. Chlorhexidine Gluconate [usp Impurity]

    91. Avagard Component Chlorhexidine Gluconate

    92. C08038

    93. D00858

    94. Chlorhexidine Digluconate Solution, 20% In H2o

    95. Soluprep Component Chlorhexidine Gluconate

    96. Chloraprep Component Chlorhexidine Gluconate

    97. Chlorhexidine Gluconate Component Of Avagard

    98. Chlorhexidine Digluconate, 20% W/v Aqueous Solution

    99. Chlorhexidine Gluconate Component Of Soluprep

    100. J-011837

    101. Chlorhexidine Gluconate Component Of Chloraprep

    102. Chlorhexidine Digluconate Solution [ep Monograph]

    103. 1,1'-hexamethylenebis[5-(4-chlorophenyl)biguanide] Digluconate

    104. Chlorhexidine Digluconate, Pharmaceutical Secondary Standard; Certified Reference Material

    105. 1,1'-hexamethylenebis[5-(p-chlorophenyl)biguanide] (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoic Acid(1:2)

    106. 1-(4-chlorophenyl)-3-[n-[6-[[n-[n-(4-chlorophenyl)carbamimidoyl]carbamimidoyl]amino]hexyl]carbamimidoyl]guanidine; (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoic Acid

    107. 2,4,11,13-tetraazatetradecanediimidamide, N,n''-bis(4-chlorophenyl)-3,12-diimino-, Digluconate

    108. 2,4,11,13-tetraazatetradecanediimidamide, N,n'-bis(4-chlorophenyl)-3,12-diimino-, Di-d-gluconate

    109. D-gluconic Acid, Compd With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

    110. D-gluconic Acid, Compd. With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecane Diimidamide (2:1)

    111. D-gluconic Acid, Compd. With N1,n14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)

    112. N',n'''''-hexane-1,6-diylbis[n-(4-chlorophenyl)(imidodicarbonimidic Diamide)]--d-gluconic Acid (1/2)

    2.4 Create Date
    2006-10-23
    3 Chemical and Physical Properties
    Molecular Weight 897.8 g/mol
    Molecular Formula C34H54Cl2N10O14
    Hydrogen Bond Donor Count18
    Hydrogen Bond Acceptor Count16
    Rotatable Bond Count23
    Exact Mass896.3198018 g/mol
    Monoisotopic Mass896.3198018 g/mol
    Topological Polar Surface Area455 Ų
    Heavy Atom Count60
    Formal Charge0
    Complexity819
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count2
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameChlorhexidine gluconate
    Drug LabelChlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium...
    Active IngredientChlorhexidine gluconate
    Dosage FormCloth; Solution; Sponge
    RouteDental; Topical
    Strength0.12%; 2%; 4%
    Market StatusOver the Counter; Prescription
    CompanyLyne; Wockhardt; Sage Prods; Hi Tech Pharma; Teva; Xttrium; Becton Dickinson

    2 of 2  
    Drug NameChlorhexidine gluconate
    Drug LabelChlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium...
    Active IngredientChlorhexidine gluconate
    Dosage FormCloth; Solution; Sponge
    RouteDental; Topical
    Strength0.12%; 2%; 4%
    Market StatusOver the Counter; Prescription
    CompanyLyne; Wockhardt; Sage Prods; Hi Tech Pharma; Teva; Xttrium; Becton Dickinson

    4.2 Therapeutic Uses

    Antiseptic; disinfectant. (Vet): antiseptic; disinfectant.

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 371

    Cleanser: As a surgical hand scrub, skin wound and general skin cleanser, health care personnel hand wash, and for preoperative skin preparation. Chlorhedine gluconate significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. /Chlorhexidine gluconate-topical/

    Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180

    EXPL THER To determine if chlorhexidine can be used as an intervention to prolong the time to relapse of oral candidiasis. SUBJECTS AND METHODS: A double-blinded randomized clinical trial was performed in 75 HIV/AIDS subjects with oral candidiasis. Clotrimazole troche was prescribed, and the subjects were re-examined every 2 weeks until the lesions were completely eradicated. The subjects were then randomly divided into two groups; 0.12% chlorhexidine (n = 37, aged 22-52 years, mean 34 years) and 0.9% normal saline (n = 38, aged 22-55 years, mean 38 years). They were re-examined every 2 weeks until the next episode was observed. RESULTS: The time to recurrence of oral candidiasis between the chlorhexidine and the saline group was not statistically significant (P > 0.05). The following variables were significantly associated with the time of recurrence; frequency of antifungal therapy (P = 0.011), total lymphocyte (P = 0.017), alcohol consumption (P = 0.043), and candidiasis on gingiva (P = 0.048). The subjects with lower lymphocyte showed shorter oral candidiasis-free periods (P = 0.034). CONCLUSIONS: Chlorhexidine showed a small but not statistically significant effect in maintenance of oral candidiasis-free period. This lack of significance may be due to the small sample size. Further study should be performed to better assess the size of the effect, or to confirm our findings.

    PMID:18627504 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3253386 Nittayananta W et al; Oral Dis. (7): 665-70 (2008)

    /EXPTL Therapy:/ Rats were injected with 10 mg/kg azoxymethane sc weekly for 12 weeks to induce colorectal cancers. At 20 weeks, subtotal colectomies were performed on rats with colorectal tumors and without peritoneal implants or liver metastases. At the time of surgery, a cut portion of the tumor was placed in the abdomen for 30 minutes; the rats then randomly received peritoneal irrigation with chlorhexidine, or sterile water (control). Eight weeks postoperatively a necropsy was performed. At that time, obvious and suspected recurrences and the anastomotic area were sampled for histologic evaluation. Significant differences were seen with chlorhexidine vs. water for gross tumor (P=0.05) and microscopic tumor (P<0.05).

    Stuntz M et al; Dis Colon Rectum 40 (9): 1058-8 (1997)

    4.3 Drug Warning

    For external use only: For external use only. Keep out of eyes, ears, and mouth. Chlorhexidine gluconate should not be used as a preoperative skin preparation of the face or head. Misuse of products containing chlorhexidine gluconate has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures. If chlohexidine gluconate should contact these areas, rinse out promptly and thoroughly with cold water. Avoid contact with neninges. Do not use in genital area. /Chlorhexidine gluconate-topical/

    Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180

    Sensitivity: Chlorhexidine gluconate should not be used by persons who have a sensitivity to it or its components.

    Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180

    Hypersensitivity reactions: Irritation, sensitization, and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. If adverse reactions occur and last more than 72 hr, discontinue use immediately and, if severe, contact a health care provider.

    Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180

    Deafness: Chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforate ear drums. /Chlorhexidine gluconate-topical/

    Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180

    For more Drug Warnings (Complete) data for CHLORHEXIDINE (8 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Infective Agents, Local

    Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. (See all compounds classified as Anti-Infective Agents, Local.)

    Dermatologic Agents

    Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Decreased Cell Wall Integrity [PE]
    5.3 Absorption, Distribution and Excretion

    34 newborn infants who had been bathed in a standard manner with Hibiscrub were studied to find out whether it was absorbed percutaneously. Low levels of chlorhexidine were found in the blood of all 10 babies sampled by heel prick, and 5 of 24 from whom venous blood was taken. /Chlorhexidine gluconate/

    PMID:475414 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1545570 Cowen J et al; Arch Dis Child 54 (5): 379-83 (1979)

    Percutaneous absorption of the antimicrobial agent chlorhexidine (labelled with carbon-14) was studied in rats. Less than 5% of the topically applied chlorhexidine was absorbed during a 5-day period. Excretion of absorbed radioactivity occurred mainly in the feces.

    Chow CP, et al; Toxicol Lett 1(4): 213-16 (1978)

    The percutaneous absorption of chlorhexidine gluconate (chlorhexidine digluconate; Hibitane) through hairless rat skin with or without stratum corneum was studied. For tests carried out on whole skin, storage in cutaneous structures after 48 hr was more important than diffusion; the reverse was observed for stripped skin. When the skin was stripped, the amount absorbed was multiplied by approximately 100, and the amount stored in skin by approximately 10. The difference in chlorhexidine diffusion observed between whole and stripped skin was related to the physicochemical characteristics of chlorhexidine. /Chlorhexidine gluconate/

    Lafforque C et al; Int J Pharm 147: 243-6 (1997)

    To evaluate the elimination kinetics of chlorhexidine in milk when used as an intramammary infusion to stop lactation in cows. ... The study was performed in 2 phases. Three cows were studied in each phase. All cows were treated with chlorhexidine suspension by infusion into a mastitic mammary gland quarter after 2 milkings 24 hours apart. Foremilk samples (100 mL) were collected from treated and untreated (controls) mammary gland quarters of each cow. Chlorhexidine was extracted from raw milk, and residue concentrations were quantified by use of high-performance liquid chromatography. Foremilk samples from days 2, 5, and 8 were analyzed in phase I, and samples from time 0 and days 3, 7, 14, 21, 28, 35, and 42 were analyzed in phase II. In phases I and II, there was no quantifiable transference of chlorhexidine to milk in untreated mammary gland quarters. Measurable chlorhexidine residues were found in milk from treated mammary gland quarters of 2 cows throughout the 42-day sample period in phase II. Estimated mean elimination half-life for chlorhexidine in milk was 11.5 days.

    PMID:12830870 Middleton JR et al; J Am Vet Med Assoc 222 (12): 1746-9 (2003)

    5.4 Biological Half-Life

    To evaluate the elimination kinetics of chlorhexidine in milk when used as an intramammary infusion to stop lactation in cows. ... The study was performed in 2 phases. Three cows were studied in each phase. All cows were treated with chlorhexidine suspension by infusion into a mastitic mammary gland quarter after 2 milkings 24 hours apart. Foremilk samples (100 mL) were collected from treated and untreated (controls) mammary gland quarters of each cow. Chlorhexidine was extracted from raw milk, and residue concentrations were quantified by use of high-performance liquid chromatography. Foremilk samples from days 2, 5, and 8 were analyzed in phase I, and samples from time 0 and days 3, 7, 14, 21, 28, 35, and 42 were analyzed in phase II. In phases I and II, there was no quantifiable transference of chlorhexidine to milk in untreated mammary gland quarters. Measurable chlorhexidine residues were found in milk from treated mammary gland quarters of 2 cows throughout the 42-day sample period in phase II. Estimated mean elimination half-life for chlorhexidine in milk was 11.5 days.

    PMID:12830870 Middleton JR et al; J Am Vet Med Assoc 222 (12): 1746-9 (2003)

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    ABOUT THIS PAGE

    Looking for 55-56-1 / Chlorhexidine Gluconate API manufacturers, exporters & distributors?

    Chlorhexidine Gluconate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Chlorhexidine Gluconate 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 Chlorhexidine Gluconate manufacturer or Chlorhexidine Gluconate supplier for your needs.

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

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

    API | Excipient name

    Chlorhexidine Gluconate

    Synonyms

    Chlorhexidine digluconate, Hibiclens, 18472-51-0, Peridex, Dyna-hex, Bioscrub

    Cas Number

    55-56-1

    Unique Ingredient Identifier (UNII)

    MOR84MUD8E

    About Chlorhexidine Gluconate

    Chlorhexidine Gluconate is the gluconate salt form of chlorhexidine, a biguanide compound used as an antiseptic agent with topical antibacterial activity. Chlorhexidine gluconate is positively charged and reacts with the negatively charged microbial cell surface, thereby destroying the integrity of the cell membrane. Subsequently, chlorhexidine gluconate penetrates into the cell and causes leakage of intracellular components leading to cell death. Since gram positive bacteria are more negatively charged, they are more sensitive to this agent.

    Chlorhexidine Digluconate Manufacturers

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

    Chlorhexidine Digluconate Suppliers

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

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

    Chlorhexidine Digluconate USDMF

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

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

    click here to find a list of Chlorhexidine Digluconate suppliers with USDMF on PharmaCompass.

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

    Chlorhexidine Digluconate KDMF

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

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

    After submitting a Chlorhexidine Digluconate 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 Chlorhexidine Digluconate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Chlorhexidine Digluconate suppliers with KDMF on PharmaCompass.

    Chlorhexidine Digluconate CEP

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

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

    Chlorhexidine Digluconate WC

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

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

    Chlorhexidine Digluconate GMP

    Chlorhexidine Digluconate 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 Chlorhexidine Digluconate 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 Chlorhexidine Digluconate GMP manufacturer or Chlorhexidine Digluconate GMP API supplier for your needs.

    Chlorhexidine Digluconate CoA

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

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

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