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    Also known as: L-phenylephrine bitartrate, 14787-58-7, 17162-39-9, 2,3-dihydroxybutanedioic acid;3-[1-hydroxy-2-(methylamino)ethyl]phenol, Phenylephrine hydrogentartrate, (r)-phenylephrine bitartrate
    Molecular Formula
    C13H19NO8
    Molecular Weight
    317.29  g/mol
    InChI Key
    NHKOTKKHHYKARN-UHFFFAOYSA-N
    Phenylephrine Bitartrate
    Phenylephrine Bitartrate is the bitartrate salt form of phenylephrine, a direct-acting sympathomimetic amine chemically related to adrenaline and ephedrine with potent vasoconstricting activity. Phenylephrine is a post-synaptic alpha-adrenergic receptor agonist that causes vasoconstriction, increases systolic/diastolic pressures, reflex bradycardia, and increases stroke output.
    1 2D Structure

    Phenylephrine Bitartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2,3-dihydroxybutanedioic acid;3-[1-hydroxy-2-(methylamino)ethyl]phenol
    2.1.2 InChI
    InChI=1S/C9H13NO2.C4H6O6/c1-10-6-9(12)7-3-2-4-8(11)5-7;5-1(3(7)8)2(6)4(9)10/h2-5,9-12H,6H2,1H3;1-2,5-6H,(H,7,8)(H,9,10)
    2.1.3 InChI Key
    NHKOTKKHHYKARN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CNCC(C1=CC(=CC=C1)O)O.C(C(C(=O)O)O)(C(=O)O)O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. L-phenylephrine Bitartrate

    2. 14787-58-7

    3. 17162-39-9

    4. 2,3-dihydroxybutanedioic Acid;3-[1-hydroxy-2-(methylamino)ethyl]phenol

    5. Phenylephrine Hydrogentartrate

    6. (r)-phenylephrine Bitartrate

    7. Schembl156709

    8. L-phenylephrinebitartrate

    9. Dtxsid40627790

    10. Bcp19493

    11. Akos015909669

    12. Db-043871

    13. Ft-0630437

    14. J-008423

    15. 2,3-dihydroxybutanedioic Acid--3-[1-hydroxy-2-(methylamino)ethyl]phenol (1/1)

    2.3 Create Date
    2007-12-05
    3 Chemical and Physical Properties
    Molecular Weight 317.29 g/mol
    Molecular Formula C13H19NO8
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count6
    Exact Mass317.11106656 g/mol
    Monoisotopic Mass317.11106656 g/mol
    Topological Polar Surface Area168 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity264
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count3
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

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    23-Sep-2021
    24-Oct-2024
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    ABOUT THIS PAGE

    Phenylephrine Bitartrate Manufacturers

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

    Phenylephrine Bitartrate Suppliers

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

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

    Phenylephrine Bitartrate USDMF

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

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

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

    Phenylephrine Bitartrate WC

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

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

    Phenylephrine Bitartrate 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 Phenylephrine Bitartrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Phenylephrine Bitartrate GMP

    Phenylephrine Bitartrate 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 Phenylephrine Bitartrate 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 Phenylephrine Bitartrate GMP manufacturer or Phenylephrine Bitartrate GMP API supplier for your needs.

    Phenylephrine Bitartrate CoA

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

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

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