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PHR1451

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Mycophenolat-Mofetil

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

Mycophenolat-Mofetil, (4E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexensäure-2-(4-morpholinyl)-ethylester

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About This Item

Empirische Formel (Hill-System):
C23H31NO7
CAS-Nummer:
Molekulargewicht:
433.49
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to Ph. Eur. Y0000489
traceable to USP 1448956

API-Familie

mycophenolate

Analysenzertifikat (CofA)

current certificate can be downloaded

Verpackung

pkg of 1 g

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

2-30°C

SMILES String

COc1c(C)c2COC(=O)c2c(O)c1C\C=C(/C)CCC(=O)OCCN3CCOCC3

InChI

1S/C23H31NO7/c1-15(5-7-19(25)30-13-10-24-8-11-29-12-9-24)4-6-17-21(26)20-18(14-31-23(20)27)16(2)22(17)28-3/h4,26H,5-14H2,1-3H3/b15-4+

InChIKey

RTGDFNSFWBGLEC-SYZQJQIISA-N

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Allgemeine Beschreibung

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Mycophenolate mofetil is a prodrug of mycophenolic acid that is utilized as an immunosuppressive agent for the treatment of renal transplant recipients. It may lead to gastrointestinal side effects.

Anwendung

Mycophenolate Mofetil may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by electrochemical method.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem./physiol. Wirkung

Mycophenolat-mofetil ist ein Pro-Pharmakon von Mycophenolsäure (Kat.-Nr. M5255), das durch unspezifische Esterase in vivo zur Stammsubstanz gespalten wird. Mycophenolsäure hemmt Inosinmonophosphat-Dehydrogenaseund ist ein wirksames immunsuppressives Mittel.

Hinweis zur Analyse

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Sonstige Hinweise

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Fußnote

To see an example of a Certificate of Analysis for this material enter LRAA2844 in the slot below. This is an example certificate only and may not be the lot that you receive.

Empfohlene Produkte

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Signalwort

Danger

Gefahreneinstufungen

Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 1

Lagerklassenschlüssel

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


Choose from one of the most recent versions:

Analysenzertifikate (COA)

Lot/Batch Number

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

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Electrochemical oxidation of an immunosuppressant, mycophenolate mofetil, and its assay in pharmaceutical formulations.
Prashanth SN, et al.
International Journal of Electrochemistry (2011)
Mycophenolic acid metabolite profile in renal transplant patients receiving enteric-coated mycophenolate sodium or mycophenolate mofetil.
Transplantation proceedings, 37(2), 852-855 (2005)
Electrochemical oxidation of an immunosuppressant, mycophenolate mofetil, and its assay in pharmaceutical formulations.
Prashanth SN, et al.
International Journal of Electrochemistry (2011)
B Rutkowski et al.
Transplantation proceedings, 46(8), 2683-2688 (2014-11-09)
The aim of this study was to show the preliminary outcomes of transplantation in patients treated with the generic formulation of mycophenolate mofetil (Myfenax, Teva). Over the past 4 years, 60 patients received generic mycophenolate mofetil (Myfenax) after renal transplantation
John Seal et al.
Transplantation, 99(3), 623-628 (2014-08-26)
There is a paucity of contemporary data describing the results of pancreas retransplantation (PRT). As a measure of utility, we wished to determine whether PRT could produce equivalent short-term and long-term recipient outcomes to primary pancreas after kidney (PAK) transplantation.

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