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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]

USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2015-09-18

Pay. Date : 2013-01-04

DMF Number : 22401

Submission : 2008-12-10

Status : Active

Type : II

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Lusochimica Spa

Italy

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DMF Review : Complete

Rev. Date : 2019-02-15

Pay. Date : 2019-02-11

DMF Number : 8940

Submission : 1991-01-18

Status : Active

Type : II

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DMF Review : N/A

Rev. Date :

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DMF Number : 4230

Submission : 1981-06-15

Status : Inactive

Type : II

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Oxymetazoline hydrochloride

Registration Number : 220MF10107

Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany

Initial Date of Registration : 2008-04-11

Latest Date of Registration : 2024-02-21

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API Reference Price

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VAISHNODE","city":"AHMEDABAD","supplier":"SIEGFRIED AG","supplierCountry":"GERMANY","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7000","totalValueFC":"7707.2","currency":"EUR","unitRateINR":"633499.8","date":"26-Jun-2023","totalValueINR":"633499.832","totalValueInUsd":"7707.2","indian_port":"BOMBAY AIR","hs_no":"29332990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"OXYMETAZOLINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"SIEGFRIED AG","supplierCountry":"GERMANY","foreign_port":"MUENSTER","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7000","totalValueFC":"7914.6","currency":"EUR","unitRateINR":"663250","date":"11-Sep-2024","totalValueINR":"663250","totalValueInUsd":"7914.6","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"5541834","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"MUENSTER","supplierAddress":"UNTERE BR?HLSTRASSE 4 4800 ZOFINGEN SWITZERLAND SDNF Switzerland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"}]
10-Jan-2021
27-Dec-2024
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ABOUT THIS PAGE

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

Oxymetazoline Hydrochloride manufacturers, exporters & distributors 1

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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)

Oxymetazoline Hydrochloride Manufacturers

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

Oxymetazoline Hydrochloride Suppliers

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

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

Oxymetazoline Hydrochloride USDMF

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

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

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

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

Oxymetazoline Hydrochloride CEP

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

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

Oxymetazoline Hydrochloride WC

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

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

Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Oxymetazoline Hydrochloride GMP

Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride 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 Oxymetazoline Hydrochloride GMP manufacturer or Oxymetazoline Hydrochloride GMP API supplier for your needs.

Oxymetazoline Hydrochloride CoA

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

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

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