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Chemistry

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Also known as: Solu-medrone, Urbason solubile, M-6-p, Nsc-48989, Methylprednisolone sodium hemisuccinate, U 9088
Molecular Formula
C26H34NaO8+
Molecular Weight
497.5  g/mol
InChI Key
FQISKWAFAHGMGT-SGJOWKDISA-N

Methylprednisolone Sodium Succinate
A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.
1 2D Structure

Methylprednisolone Sodium Succinate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;4-[2-[(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethoxy]-4-oxobutanoic acid
2.1.2 InChI
InChI=1S/C26H34O8.Na/c1-14-10-16-17-7-9-26(33,20(29)13-34-22(32)5-4-21(30)31)25(17,3)12-19(28)23(16)24(2)8-6-15(27)11-18(14)24;/h6,8,11,14,16-17,19,23,28,33H,4-5,7,9-10,12-13H2,1-3H3,(H,30,31);/q;+1/t14-,16-,17-,19-,23+,24-,25-,26-;/m0./s1
2.1.3 InChI Key
FQISKWAFAHGMGT-SGJOWKDISA-N
2.1.4 Canonical SMILES
CC1CC2C3CCC(C3(CC(C2C4(C1=CC(=O)C=C4)C)O)C)(C(=O)COC(=O)CCC(=O)O)O.[Na+]
2.1.5 Isomeric SMILES
C[C@H]1C[C@H]2[C@@H]3CC[C@@]([C@]3(C[C@@H]([C@@H]2[C@@]4(C1=CC(=O)C=C4)C)O)C)(C(=O)COC(=O)CCC(=O)O)O.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 6 Alpha-methylprednisolone Sodium Hemisuccinate

2. A-methapred

3. Hemisuccinate, Methylprednisolone

4. Methylprednisolone Hemisuccinate

5. Methylprednisolone Hemisuccinate Monosodium Salt

6. Methylprednisolone Sodium Hemisuccinate

7. Methylprednisolone Sodium Succinate

8. Methylprednisolone Succinate

9. Sodium Hemisuccinate, Methylprednisolone

10. Sodium Succinate, Methylprednisolone

11. Solumedrol

12. Succinate, Methylprednisolone

13. Urbason-soluble

14. Urbasonsoluble

2.2.2 Depositor-Supplied Synonyms

1. Solu-medrone

2. Urbason Solubile

3. M-6-p

4. Nsc-48989

5. Methylprednisolone Sodium Hemisuccinate

6. U 9088

7. Urabason

8. 2375-03-3

9. Nsc48989

10. Prednisolone, Succinate, Sodium Salt

11. 6.alpha.-methylprednisolone Sodium Succinate

12. 6.alpha.-methylprednisolone 21-sodium Succinate

13. 6.alpha.-methylprednisolone Sodium Hemisuccinate

14. 6.alpha.-methylpregnisolone 21-sodium Succinate

15. 6.alpha.-methylprednisolone 21-sodium Hemisuccinate

16. 6.alpha.-methylprednisolone 21-hemisuccinate Sodium Salt

17. Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-, 21-(hydrogen Succinate), Monosodium Salt

18. Pregna-1,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-, Monosodium Salt, (6.alpha.,11.beta.)-

2.3 Create Date
2011-12-19
3 Chemical and Physical Properties
Molecular Weight 497.5 g/mol
Molecular Formula C26H34NaO8+
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count7
Exact Mass497.21513732 g/mol
Monoisotopic Mass497.21513732 g/mol
Topological Polar Surface Area138 Ų
Heavy Atom Count35
Formal Charge1
Complexity981
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameMethylprednisolone sodium succinate
Drug LabelSOLU-MEDROL Sterile Powder is an antiflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs...
Active IngredientMethylprednisolone sodium succinate
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 40mg base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyMustafa Nevsat; Fresenius Kabi Usa

2 of 2  
Drug NameMethylprednisolone sodium succinate
Drug LabelSOLU-MEDROL Sterile Powder is an antiflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs...
Active IngredientMethylprednisolone sodium succinate
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 40mg base/vial; eq 125mg base/vial; eq 500mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyMustafa Nevsat; Fresenius Kabi Usa

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


Antineoplastic Agents, Hormonal

Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)


Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)


Neuroprotective Agents

Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

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02-Mar-2021
22-Nov-2024
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Methylprednisolone Sodium Succinate Manufacturers

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

Methylprednisolone Sodium Succinate Suppliers

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

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

Methylprednisolone Sodium Succinate USDMF

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

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

click here to find a list of Methylprednisolone Sodium Succinate suppliers with USDMF on PharmaCompass.

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

Methylprednisolone Sodium Succinate KDMF

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

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

After submitting a Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Methylprednisolone Sodium Succinate suppliers with KDMF on PharmaCompass.

Methylprednisolone Sodium Succinate WC

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

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

Methylprednisolone Sodium Succinate GMP

Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate GMP manufacturer or Methylprednisolone Sodium Succinate GMP API supplier for your needs.

Methylprednisolone Sodium Succinate CoA

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

Methylprednisolone Sodium Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Methylprednisolone Sodium Succinate 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.

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