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    Also known as: Afrinol, 7460-12-0, Sch 4855, D-isoephedrine sulfate, Pseudoephedrine sulphate, D-pseudoephedrine sulfate
    Molecular Formula
    C20H32N2O6S
    Molecular Weight
    428.5  g/mol
    InChI Key
    CAVQBDOACNULDN-NRCOEFLKSA-N
    FDA UNII
    Y9DL7QPE6B
    Pseudoephedrine Sulfate
    Pseudoephedrine Sulfate is the sulfate salt form of pseudoephedrine, a phenethylamine and a diastereomer of ephedrine with sympathomimetic property. Pseudoephedrine sulfate displaces norepinephrine from storage vesicles in presynaptic neurones, thereby releasing norepinephrine into the neuronal synapses where it stimulates primarily alpha-adrenergic receptors. It also has weak direct agonist activity at alpha- and beta- adrenergic receptors. Receptor stimulation results in vasoconstriction and decreases nasal and sinus congestion.
    1 2D Structure

    Pseudoephedrine Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol;sulfuric acid
    2.1.2 InChI
    InChI=1S/2C10H15NO.H2O4S/c2*1-8(11-2)10(12)9-6-4-3-5-7-9;1-5(2,3)4/h2*3-8,10-12H,1-2H3;(H2,1,2,3,4)/t2*8-,10+;/m00./s1
    2.1.3 InChI Key
    CAVQBDOACNULDN-NRCOEFLKSA-N
    2.1.4 Canonical SMILES
    CC(C(C1=CC=CC=C1)O)NC.CC(C(C1=CC=CC=C1)O)NC.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C[C@@H]([C@H](C1=CC=CC=C1)O)NC.C[C@@H]([C@H](C1=CC=CC=C1)O)NC.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    Y9DL7QPE6B
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. Afrinol

    2. 7460-12-0

    3. Sch 4855

    4. D-isoephedrine Sulfate

    5. Pseudoephedrine Sulphate

    6. D-pseudoephedrine Sulfate

    7. Y9dl7qpe6b

    8. Sch-4855

    9. (+)-pseudoephedrine Sulfate

    10. (+)-pseudoephedrine Sulphate

    11. Disobrom Component Pseudoephedrine Sulfate

    12. Drixoral Component Pseudoephedrine Sulfate

    13. Resporal Component Pseudoephedrine Sulfate

    14. Trinalin Component Pseudoephedrine Sulfate

    15. Disophrol Component Pseudoephedrine Sulfate

    16. Brompheril Component Pseudoephedrine Sulfate

    17. Clarinex-d Component Pseudoephedrine Sulfate

    18. Claritin-d Component Pseudoephedrine Sulfate

    19. Pseudoephedrine Sulfate Component Of Disobrom

    20. Pseudoephedrine Sulfate Component Of Disophrol

    21. Pseudoephedrine Sulfate Component Of Drixoral

    22. Pseudoephedrine Sulfate Component Of Resporal

    23. Pseudoephedrine Sulfate Component Of Trinalin

    24. Drixoral Plus Component Pseudoephedrine Sulfate

    25. Pseudoephedrine Sulfate Component Of Brompheril

    26. Pseudoephedrine Sulfate Component Of Clarinex-d

    27. Pseudoephedrine Sulfate Component Of Claritin-d

    28. Pseudoephedrine Sulfate Component Of Drixoral Plus

    29. Afrin Tablets

    30. Duration Tablets

    31. Drixoral Nd

    32. Pseudoephedrine Sulfate (mart.)

    33. Pseudoephedrine Sulfate [mart.]

    34. Pseudoephedrine Sulfate (usp-rs)

    35. Pseudoephedrine Sulfate [usp-rs]

    36. Chlor-trimeton Nd

    37. Pseudoephedrine Sulfate (usp Monograph)

    38. Pseudoephedrine Sulfate [usp Monograph]

    39. Unii-y9dl7qpe6b

    40. Pseudoephedrine Sulfate [usan]

    41. Afrinol (tn)

    42. Einecs 231-243-2

    43. Pseudoephedrine Sulfate [usan:usp]

    44. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;sulfuric Acid

    45. (+)-pseudoephedrine Sulfate (2:1) (salt)

    46. Ec 231-243-2

    47. Schembl41308

    48. Pseudoephedrine Sulfate (usp)

    49. Threo-1-hydroxy-2-methylamino-1-phenylpropane Sulfate

    50. Chembl3989855

    51. Dtxsid20889379

    52. Pseudoephedrine Sulfate [mi]

    53. Pseudoephedrine Sulfate [vandf]

    54. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, (.alpha.s)-, Sulfate (2:1) (salt)

    55. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, (s-(r*,r*))-, Sulfate (2:1) (salt)

    56. Pseudoephedrine Sulfate [who-dd]

    57. Pseudoephedrine Sulfate [orange Book]

    58. D05649

    59. Q27294410

    60. Pseudoephedrine Sulfate, United States Pharmacopeia (usp) Reference Standard

    61. Benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, (s-(r (sup *),r (sup *))-

    62. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, (.alpha.s)-, Sulfate (2:1)

    63. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, (alphas)-, Sulfate (2:1)

    64. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, (alphas)-, Sulfate (2:1) (salt)

    65. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, (alphas)-,sulfate (2:1) (salt)

    66. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, (s-(r (sup *),r (sup *))-

    67. Bis((s-(r*,r*))-(beta-hydroxy-alpha-methylphenethyl)methylammonium) Sulphate

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 428.5 g/mol
    Molecular Formula C20H32N2O6S
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count6
    Exact Mass g/mol
    Monoisotopic Mass g/mol
    Topological Polar Surface Area148
    Heavy Atom Count29
    Formal Charge0
    Complexity202
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

    API Reference Price

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    25-Jan-2022
    11-Mar-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG

    USFDA APPLICATION NUMBER - 19670

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG

    USFDA APPLICATION NUMBER - 20470

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

    USFDA APPLICATION NUMBER - 21313

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    ABOUT THIS PAGE

    Looking for 7460-12-0 / Pseudoephedrine Sulfate API manufacturers, exporters & distributors?

    Pseudoephedrine Sulfate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Pseudoephedrine Sulfate 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 Pseudoephedrine Sulfate manufacturer or Pseudoephedrine Sulfate supplier for your needs.

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

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

    API | Excipient name

    Pseudoephedrine Sulfate

    Synonyms

    Afrinol, 7460-12-0, Sch 4855, D-isoephedrine sulfate, Pseudoephedrine sulphate, D-pseudoephedrine sulfate

    Cas Number

    7460-12-0

    Unique Ingredient Identifier (UNII)

    Y9DL7QPE6B

    About Pseudoephedrine Sulfate

    Pseudoephedrine Sulfate is the sulfate salt form of pseudoephedrine, a phenethylamine and a diastereomer of ephedrine with sympathomimetic property. Pseudoephedrine sulfate displaces norepinephrine from storage vesicles in presynaptic neurones, thereby releasing norepinephrine into the neuronal synapses where it stimulates primarily alpha-adrenergic receptors. It also has weak direct agonist activity at alpha- and beta- adrenergic receptors. Receptor stimulation results in vasoconstriction and decreases nasal and sinus congestion.

    Pseudoephedrine Sulfate Manufacturers

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

    Pseudoephedrine Sulfate Suppliers

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

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

    Pseudoephedrine Sulfate USDMF

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

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

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

    Pseudoephedrine Sulfate KDMF

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

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

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

    click here to find a list of Pseudoephedrine Sulfate suppliers with KDMF on PharmaCompass.

    Pseudoephedrine Sulfate WC

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

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

    Pseudoephedrine Sulfate 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 Pseudoephedrine Sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Pseudoephedrine Sulfate GMP

    Pseudoephedrine Sulfate 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 Pseudoephedrine Sulfate 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 Pseudoephedrine Sulfate GMP manufacturer or Pseudoephedrine Sulfate GMP API supplier for your needs.

    Pseudoephedrine Sulfate CoA

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

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

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