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    Also known as: (-)-epinephrine bitartrate, Adrenaline bitartrate, Mls000028381, Epinephrine d-bitartrate, L-epinephrine bitartrate, Smr000058630
    Molecular Formula
    C13H19NO9
    Molecular Weight
    333.29  g/mol
    InChI Key
    YLXIPWWIOISBDD-FVGYRXGTSA-N
    Epinephrine Bitartrate
    The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS.
    1 2D Structure

    Epinephrine Bitartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2,3-dihydroxybutanedioic acid;4-[(1R)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol
    2.1.2 InChI
    InChI=1S/C9H13NO3.C4H6O6/c1-10-5-9(13)6-2-3-7(11)8(12)4-6;5-1(3(7)8)2(6)4(9)10/h2-4,9-13H,5H2,1H3;1-2,5-6H,(H,7,8)(H,9,10)/t9-;/m0./s1
    2.1.3 InChI Key
    YLXIPWWIOISBDD-FVGYRXGTSA-N
    2.1.4 Canonical SMILES
    CNCC(C1=CC(=C(C=C1)O)O)O.C(C(C(=O)O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CNC[C@@H](C1=CC(=C(C=C1)O)O)O.C(C(C(=O)O)O)(C(=O)O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 4-(1-hydroxy-2-(methylamino)ethyl)-1,2-benzenediol

    2. Acetate, Epinephrine

    3. Adrenaline

    4. Adrenaline Acid Tartrate

    5. Adrenaline Bitartrate

    6. Adrenaline Hydrochloride

    7. Epifrin

    8. Epinephrine

    9. Epinephrine Acetate

    10. Epinephrine Bitartrate

    11. Epinephrine Hydrochloride

    12. Epitrate

    13. Lyophrin

    14. Medihaler-epi

    2.2.2 Depositor-Supplied Synonyms

    1. (-)-epinephrine Bitartrate

    2. Adrenaline Bitartrate

    3. Mls000028381

    4. Epinephrine D-bitartrate

    5. L-epinephrine Bitartrate

    6. Smr000058630

    7. Adrenaline Bitartate

    8. Adrenaline (as Tartrate)

    9. Sr-01000075267

    10. L-epinephrine Hydrogen Tartrate

    11. Adrenalin Tartrate

    12. Nsc-756755

    13. Opera_id_1462

    14. Epinephrini Hydrogenotartras

    15. Lopac0_000502

    16. Schembl597216

    17. Chembl1256958

    18. L-adrenaline Hydrogen Bitartrate

    19. L-epinephrine Hydrogen Bitartrate

    20. Hms2233k16

    21. Hms3261f05

    22. Tox21_500502

    23. Akos030504417

    24. Ccg-221806

    25. Lp00502

    26. Ncgc00093902-01

    27. Ncgc00261187-01

    28. A0175

    29. Eu-0100502

    30. E 4375

    31. Sr-01000075267-1

    32. Sr-01000075267-4

    33. Sr-01000075267-6

    2.3 Create Date
    2006-06-15
    3 Chemical and Physical Properties
    Molecular Weight 333.29 g/mol
    Molecular Formula C13H19NO9
    Hydrogen Bond Donor Count8
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count6
    Exact Mass333.10598118 g/mol
    Monoisotopic Mass333.10598118 g/mol
    Topological Polar Surface Area188 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity288
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Adrenergic alpha-Agonists

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

    Adrenergic beta-Agonists

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

    Bronchodilator Agents

    Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

    Mydriatics

    Agents that dilate the pupil. They may be either sympathomimetics or parasympatholytics. (See all compounds classified as Mydriatics.)

    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.)

    Vasoconstrictor Agents

    Drugs used to cause constriction of the blood vessels. (See all compounds classified as Vasoconstrictor Agents.)

    API Reference Price

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    22-Jan-2021
    21-Mar-2025
    KGS
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    DOSAGE - INJECTABLE;INJECTION - 0.25%

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.5%

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.75%

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 16964

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    DOSAGE - INJECTABLE;INJECTION - 0.25%

    USFDA APPLICATION NUMBER - 18304

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    DOSAGE - INJECTABLE;INJECTION - 0.5%

    USFDA APPLICATION NUMBER - 18304

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    DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 18304

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    DOSAGE - INJECTABLE;INJECTION - 0.75%

    USFDA APPLICATION NUMBER - 18304

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    DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 18304

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    DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085...DOSAGE - INJECTABLE;INJECTION - 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

    USFDA APPLICATION NUMBER - 20971

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    DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG...DOSAGE - INJECTABLE;INJECTION - 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

    USFDA APPLICATION NUMBER - 20971

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    DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

    USFDA APPLICATION NUMBER - 22046

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    DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%

    USFDA APPLICATION NUMBER - 88389

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    DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

    USFDA APPLICATION NUMBER - 88390

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    ABOUT THIS PAGE

    Looking for 51-42-3 / Epinephrine Bitartrate API manufacturers, exporters & distributors?

    Epinephrine Bitartrate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Epinephrine Bitartrate 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 Epinephrine Bitartrate manufacturer or Epinephrine Bitartrate supplier for your needs.

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

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

    API | Excipient name

    Epinephrine Bitartrate

    Synonyms

    (-)-epinephrine bitartrate, Adrenaline bitartrate, Mls000028381, Epinephrine d-bitartrate, L-epinephrine bitartrate, Smr000058630

    Cas Number

    51-42-3

    About Epinephrine Bitartrate

    The active sympathomimetic hormone from the ADRENAL MEDULLA. It stimulates both the alpha- and beta- adrenergic systems, causes systemic VASOCONSTRICTION and gastrointestinal relaxation, stimulates the HEART, and dilates BRONCHI and cerebral vessels. It is used in ASTHMA and CARDIAC FAILURE and to delay absorption of local ANESTHETICS.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Manufacturers

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

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Suppliers

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

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

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE USDMF

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

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

    click here to find a list of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers with USDMF on PharmaCompass.

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

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE KDMF

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

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

    After submitting a PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 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 PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers with KDMF on PharmaCompass.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE CEP

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

    A PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 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 PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers with CEP (COS) on PharmaCompass.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE WC

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

    click here to find a list of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers with Written Confirmation (WC) on PharmaCompass.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE 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 PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers with NDC on PharmaCompass.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE GMP

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE 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 PRILOCAINE HYDROCHLORIDE; EPINEPHRINE 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 PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE GMP manufacturer or PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE GMP API supplier for your needs.

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE CoA

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

    PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE CoA mostly includes findings from lab analyses of a specific batch. For each PRILOCAINE HYDROCHLORIDE; EPINEPHRINE 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.

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