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    Chemistry

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    Also known as: 2315-02-8, Oxymetazoline hcl, Ocuclear, Afrazine, Afrin hydrochloride, Sch 9384
    Molecular Formula
    C16H25ClN2O
    Molecular Weight
    296.83  g/mol
    InChI Key
    BEEDODBODQVSIM-UHFFFAOYSA-N
    FDA UNII
    K89MJ0S5VY
    Oxymetazoline Hydrochloride
    A direct acting sympathomimetic used as a vasoconstrictor to relieve nasal congestion. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1251)
    1 2D Structure

    Oxymetazoline Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    6-tert-butyl-3-(4,5-dihydro-1H-imidazol-2-ylmethyl)-2,4-dimethylphenol;hydrochloride
    2.1.2 InChI
    InChI=1S/C16H24N2O.ClH/c1-10-8-13(16(3,4)5)15(19)11(2)12(10)9-14-17-6-7-18-14;/h8,19H,6-7,9H2,1-5H3,(H,17,18);1H
    2.1.3 InChI Key
    BEEDODBODQVSIM-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=C(C(=C1CC2=NCCN2)C)O)C(C)(C)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    K89MJ0S5VY
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Hydrochloride, Oxymetazoline

    2. Oxymetazoline

    2.3.2 Depositor-Supplied Synonyms

    1. 2315-02-8

    2. Oxymetazoline Hcl

    3. Ocuclear

    4. Afrazine

    5. Afrin Hydrochloride

    6. Sch 9384

    7. Rhofade

    8. Oxymetazoline (hydrochloride)

    9. Visine L.r.

    10. Vicks Sinex

    11. Nsc-757254

    12. K89mj0s5vy

    13. 6-tert-butyl-3-(4,5-dihydro-1h-imidazol-2-ylmethyl)-2,4-dimethylphenol;hydrochloride

    14. Mls000038040

    15. Chebi:7863

    16. Agn-199201

    17. Sch-9384

    18. Smr000059324

    19. 2-(4-t-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazolinium Chloride

    20. 2,6-dimethyl-2-(4-tertiarybutyl-3-hydroxyphenyl)methylimidazoline Hydrochloride

    21. 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Monohydrochloride

    22. 6-tert-butyl-3-(4,5-dihydro-1h-imidazol-2-ylmethyl)-2,4-dimethylphenol Hydrochloride

    23. Phenol, 3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-6-(1,1-dimethylethyl)-2,4-dimethyl-, Monohydrochloride

    24. 2-(3-hydroxy-2,6-dimethyl-4-tert-butylbenzyl)-2-imidazoline

    25. Lliadine

    26. Nasivin

    27. Nasivine

    28. Neonabel

    29. Nostrilla

    30. Nafrine Hydrochloride

    31. 4-way Nasal Spray

    32. Duration Nasal Spray

    33. Oxymetazoline Chloride

    34. Lliadin Mini Paediatric

    35. Sr-01000002705

    36. Neo-synephrine 12 Hour

    37. Neo-synephrine 12 Hour Ntz

    38. Sinex

    39. Anefrin Nasal

    40. Duration 12 Hour Nasal Spray

    41. Benzedrex Nasal Spray 12 Hour

    42. Dristan Long Lasting Nasal Mist

    43. Sudafed Om

    44. Ocuclear (tn)

    45. Prestwick_373

    46. Einecs 219-015-0

    47. St. Joseph Nasal Spray For Children

    48. Mfcd00058147

    49. Rhfade (tn)

    50. Upneeq

    51. Opera_id_32

    52. 2-(3-hydroxy-2,6-dimethyl-4-t-butylbenzyl)-2-imidazoline Hydrochloride

    53. Unii-k89mj0s5vy

    54. 3-[(4,5-dihydro-

    55. Schembl41247

    56. Mls002222207

    57. Spectrum1500453

    58. Oxymetazoline Hydrochloride,(s)

    59. Chembl1200791

    60. Hy-b0427a

    61. Dtxsid80177729

    62. Oximetazoline Hydrochloride

    63. Hms1568n09

    64. Hms1920d18

    65. Pharmakon1600-01500453

    66. Tox21_500903

    67. Ccg-40216

    68. Nsc757254

    69. 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Hydrochloride

    70. Akos000280887

    71. Oxymetazoline Hydrochloride (jan/usp)

    72. Phenol, 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethyl-, Hydrochloride

    73. Ks-5222

    74. Lp00903

    75. Nsc 757254

    76. Oxymetazoline Hydrochloride [mi]

    77. Ncgc00094218-01

    78. Ncgc00094218-02

    79. Ncgc00094218-03

    80. Ncgc00094218-04

    81. Ncgc00094218-05

    82. Ncgc00261588-01

    83. Oxymetazoline Hydrochloride [jan]

    84. 2315-02-8 (hcl)

    85. Oxymetazoline Hydrochloride [usan]

    86. Oxymetazoline Hydrochloride [mart.]

    87. Oxymetazoline Hydrochloride [vandf]

    88. 4-(2-boc-amino-pyridin-4-yl)-benzoicacid

    89. Oxymetazoline Hydrochloride [who-dd]

    90. Oxymetazoline Hydrochloride, >=99%, Solid

    91. Eu-0100903

    92. Ft-0673462

    93. O0520

    94. Oxymetazoline Hydrochloride [usan:usp:jan]

    95. Sw196632-3

    96. D01022

    97. D91882

    98. O 2378

    99. Oxymetazoline Hydrochloride, Analytical Standard

    100. Oxymetazoline Hydrochloride [orange Book]

    101. 315o028

    102. A910982

    103. Oxymetazoline Hydrochloride [ep Monograph]

    104. Oxymetazoline Hydrochloride [usp Impurity]

    105. Oxymetazoline Hydrochloride [usp Monograph]

    106. Kovanaze Component Oxymetazoline Hydrochloride

    107. Sr-01000002705-2

    108. Sr-01000002705-4

    109. Sr-01000002705-7

    110. W-107424

    111. Q27107602

    112. Oxymetazoline Hydrochloride Component Of Kovanaze

    113. Sinex Vapospray Moisturizing 12-hour Decongestant Ultrafine Mist

    114. 2,6-dimethyl-4-tertiarybutyl-3-hydroxyphenyl)methylimidazoline Hydrochloride

    115. 2-(4-tert-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazolinium Chloride

    116. 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Hydrochloride

    117. Oxymetazoline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    118. 1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol Hydrochloride

    119. 2-(3-hydroxy-2,6-dimethyl-4-tert-butylbenzyl)-2-imidazoline Hydrochloride

    120. 2-(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-4,5-dihydro-1h-imidazol-1-ium Chloride

    121. 6-(tert-butyl)-3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-2,4-dimethylphenol Hydrochloride

    122. 6-tert-butyl-3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-2,4-dimethylphenol Hydrochloride

    123. Oxymetazoline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    124. Oxymetazoline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    125. 3-[(4,5-dihydro-1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol Hydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 296.83 g/mol
    Molecular Formula C16H25ClN2O
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count3
    Exact Mass296.1655411 g/mol
    Monoisotopic Mass296.1655411 g/mol
    Topological Polar Surface Area44.6 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity345
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Nasal Decongestants

    Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)

    Sympathomimetics

    Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)

    Adrenergic alpha-Agonists

    Drugs that selectively bind to and activate alpha adrenergic receptors. (See all compounds classified as Adrenergic alpha-Agonists.)

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    Increased Sympathetic Activity [PE]; Vasoconstriction [PE]; Vasoconstrictor [EPC]; Imidazolines [CS]

    API Reference Price

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    12-Jan-2021
    31-Mar-2025
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    ABOUT THIS PAGE

    Looking for 2315-02-8 / Oxymetazoline Hydrochloride API manufacturers, exporters & distributors?

    Oxymetazoline Hydrochloride manufacturers, exporters & distributors 1

    35

    PharmaCompass offers a list of Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride manufacturer or Oxymetazoline Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Oxymetazoline Hydrochloride

    Synonyms

    2315-02-8, Oxymetazoline hcl, Ocuclear, Afrazine, Afrin hydrochloride, Sch 9384

    Cas Number

    2315-02-8

    Unique Ingredient Identifier (UNII)

    K89MJ0S5VY

    About Oxymetazoline Hydrochloride

    A direct acting sympathomimetic used as a vasoconstrictor to relieve nasal congestion. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1251)

    OCUCLEAR Manufacturers

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

    OCUCLEAR Suppliers

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

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

    OCUCLEAR USDMF

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

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

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

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

    OCUCLEAR CEP

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

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

    OCUCLEAR WC

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

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

    OCUCLEAR 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 OCUCLEAR as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    OCUCLEAR GMP

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

    OCUCLEAR CoA

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

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

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