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Key Documents

PHR1451

Supelco

Mycophenolate Mofetil

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Mycophenolate mofetil, MMF, (4E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid 2-(4-morpholinyl)ethyl ester, RS 61443, TM-MMF

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About This Item

Formula empirica (notazione di Hill):
C23H31NO7
Numero CAS:
Peso molecolare:
433.49
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0000489
traceable to USP 1448956

Famiglia di API

mycophenolate

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-30°C

Stringa SMILE

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+
RTGDFNSFWBGLEC-SYZQJQIISA-N

Informazioni sul gene

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Descrizione generale

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.

Applicazioni

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.

Azioni biochim/fisiol

Mycophenolate mofetil is a prodrug of mycophenolic acid (Cat. # M5255) that is cleaved by nonspecific esterases in vivo to produce the parent compound. Mycophenolic acid blocks inosine monophosphate dehydrogenase and is a potent immunosuppresive agent.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

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.

Prodotti consigliati

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.

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

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

Codice della classe di stoccaggio

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

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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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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