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    Chemistry

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    Also known as: Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11.beta.)-, Schembl1650407, Akos025394281, Ft-0631728
    Molecular Formula
    C21H27Na2O8P
    Molecular Weight
    484.4  g/mol
    InChI Key
    VJZLQIPZNBPASX-UHFFFAOYSA-L
    Prednisolone Sodium Phosphate
    1 2D Structure

    Prednisolone Sodium Phosphate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    disodium;[2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] phosphate
    2.1.2 InChI
    InChI=1S/C21H29O8P.2Na/c1-19-7-5-13(22)9-12(19)3-4-14-15-6-8-21(25,17(24)11-29-30(26,27)28)20(15,2)10-16(23)18(14)19;;/h5,7,9,14-16,18,23,25H,3-4,6,8,10-11H2,1-2H3,(H2,26,27,28);;/q;2*+1/p-2
    2.1.3 InChI Key
    VJZLQIPZNBPASX-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    CC12CC(C3C(C1CCC2(C(=O)COP(=O)([O-])[O-])O)CCC4=CC(=O)C=CC34C)O.[Na+].[Na+]
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, Disodium Salt, (11.beta.)-

    2. Schembl1650407

    3. Akos025394281

    4. Ft-0631728

    2.3 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 484.4 g/mol
    Molecular Formula C21H27Na2O8P
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count3
    Exact Mass484.12389338 g/mol
    Monoisotopic Mass484.12389338 g/mol
    Topological Polar Surface Area147 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity878
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count7
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NamePrednisolone sodium phosphate
    Active IngredientPrednisolone sodium phosphate
    Dosage FormSolution/drops; Tablet, orally disintegrating; Solution
    RouteOphthalmic; Oral
    Strengtheq 15mg base/5ml; eq 5mg base/5ml; eq 25mg base/5ml; eq 15mg base; eq 10mg base/5ml; eq 20mg base/5ml; eq 30mg base; eq 0.9% phosphate; eq 10mg base
    Market StatusPrescription
    CompanyMylan Pharms; Amneal Pharms; Wockhardt; Pharm Assoc; Mission Pharma; Hi Tech Pharma; Paddock; Vintage; Bausch And Lomb

    2 of 2  
    Drug NamePrednisolone sodium phosphate
    Active IngredientPrednisolone sodium phosphate
    Dosage FormSolution/drops; Tablet, orally disintegrating; Solution
    RouteOphthalmic; Oral
    Strengtheq 15mg base/5ml; eq 5mg base/5ml; eq 25mg base/5ml; eq 15mg base; eq 10mg base/5ml; eq 20mg base/5ml; eq 30mg base; eq 0.9% phosphate; eq 10mg base
    Market StatusPrescription
    CompanyMylan Pharms; Amneal Pharms; Wockhardt; Pharm Assoc; Mission Pharma; Hi Tech Pharma; Paddock; Vintage; Bausch And Lomb

    API Reference Price

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    22-Jan-2021
    27-Feb-2025
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    ABOUT THIS PAGE

    Looking for 125-02-0 / Prednisolone Sodium Phosphate API manufacturers, exporters & distributors?

    Prednisolone Sodium Phosphate manufacturers, exporters & distributors 1

    67

    PharmaCompass offers a list of Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate manufacturer or Prednisolone Sodium Phosphate supplier for your needs.

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

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

    API | Excipient name

    Prednisolone Sodium Phosphate

    Synonyms

    Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11.beta.)-, Schembl1650407, Akos025394281, Ft-0631728

    Cas Number

    125-02-0

    Prednisolone Sodium Phosphate Manufacturers

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

    Prednisolone Sodium Phosphate Suppliers

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

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

    Prednisolone Sodium Phosphate USDMF

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

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

    click here to find a list of Prednisolone Sodium Phosphate suppliers with USDMF on PharmaCompass.

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

    Prednisolone Sodium Phosphate CEP

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

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

    Prednisolone Sodium Phosphate WC

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

    click here to find a list of Prednisolone Sodium Phosphate suppliers with Written Confirmation (WC) on PharmaCompass.

    Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Prednisolone Sodium Phosphate suppliers with NDC on PharmaCompass.

    Prednisolone Sodium Phosphate GMP

    Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate GMP manufacturer or Prednisolone Sodium Phosphate GMP API supplier for your needs.

    Prednisolone Sodium Phosphate CoA

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

    Prednisolone Sodium Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Prednisolone Sodium Phosphate 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.

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