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    Chemistry

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    Also known as: Mls002637530, Hydrocortisoni acetas, Ncgc00183367-01, Chembl1715636, Schembl13026148, Hms2232p13
    Molecular Formula
    C23H32O6
    Molecular Weight
    404.5  g/mol
    InChI Key
    ALEXXDVDDISNDU-UHFFFAOYSA-N
    Hydrocortisone Acetate
    1 2D Structure

    Hydrocortisone Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] acetate
    2.1.2 InChI
    InChI=1S/C23H32O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h10,16-18,20,26,28H,4-9,11-12H2,1-3H3
    2.1.3 InChI Key
    ALEXXDVDDISNDU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(=O)OCC(=O)C1(CCC2C1(CC(C3C2CCC4=CC(=O)CCC34C)O)C)O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Mls002637530

    2. Hydrocortisoni Acetas

    3. Ncgc00183367-01

    4. Chembl1715636

    5. Schembl13026148

    6. Hms2232p13

    7. Hms3373l06

    8. Bbl033683

    9. Stl301800

    10. Akos001582713

    11. Akos021734921

    12. [2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] Acetate

    13. Ac-12502

    14. Smr001317857

    15. Vs-12217

    16. Ft-0627126

    17. Ft-0667894

    18. Ah-034/06873032

    19. Pregn-4-ene-3,20-dione,11beta,17alpha,21-trihydroxy-,21 Acetate

    20. 2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate

    21. 2-{1,10-dihydroxy-9a,11a-dimethyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl}-2-oxoethyl Acetate

    2.3 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 404.5 g/mol
    Molecular Formula C23H32O6
    XLogP32.2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass404.21988874 g/mol
    Monoisotopic Mass404.21988874 g/mol
    Topological Polar Surface Area101 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity786
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count7
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameHydrocortisone acetate
    Drug LabelEpifoam (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 1...
    Active IngredientHydrocortisone acetate
    Dosage FormCream; Powder
    RouteFor rx compounding; Topical
    Strength100%; 2.5%
    Market StatusPrescription
    CompanyX Gen Pharms; Ferndale Labs

    2 of 2  
    Drug NameHydrocortisone acetate
    Drug LabelEpifoam (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 1...
    Active IngredientHydrocortisone acetate
    Dosage FormCream; Powder
    RouteFor rx compounding; Topical
    Strength100%; 2.5%
    Market StatusPrescription
    CompanyX Gen Pharms; Ferndale Labs

    API Reference Price

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    09-Jan-2021
    20-Jan-2025
    KGS
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    DOSAGE - AEROSOL, METERED;RECTAL - 10%

    USFDA APPLICATION NUMBER - 17351

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    DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50218

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    ABOUT THIS PAGE

    Looking for 42016-02-4 / Hydrocortisone Acetate API manufacturers, exporters & distributors?

    Hydrocortisone Acetate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Hydrocortisone Acetate 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 Hydrocortisone Acetate manufacturer or Hydrocortisone Acetate supplier for your needs.

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

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

    API | Excipient name

    Hydrocortisone Acetate

    Synonyms

    Mls002637530, Hydrocortisoni acetas, Ncgc00183367-01, Chembl1715636, Schembl13026148, Hms2232p13

    Cas Number

    42016-02-4

    Hydrocortisone Acetate Manufacturers

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

    Hydrocortisone Acetate Suppliers

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

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

    Hydrocortisone Acetate USDMF

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

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

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

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

    Hydrocortisone Acetate KDMF

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

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

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

    click here to find a list of Hydrocortisone Acetate suppliers with KDMF on PharmaCompass.

    Hydrocortisone Acetate CEP

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

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

    Hydrocortisone Acetate WC

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

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

    Hydrocortisone Acetate 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 Hydrocortisone Acetate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Hydrocortisone Acetate GMP

    Hydrocortisone Acetate 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 Hydrocortisone Acetate 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 Hydrocortisone Acetate GMP manufacturer or Hydrocortisone Acetate GMP API supplier for your needs.

    Hydrocortisone Acetate CoA

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

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

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