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Merck

PHR1451

Mycophenolate Mofetil

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

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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Fórmula empírica (notación de Hill):
C23H31NO7
Número CAS:
128794-94-5
Peso molecular:
433.49
NACRES:
NA.24
PubChem Substance ID:
329822611
UNSPSC Code:
41116107
MDL number:
MFCD00867568

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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+

SMILES string

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

InChI key

RTGDFNSFWBGLEC-SYZQJQIISA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000489, traceable to USP 1448956

API family

mycophenolate

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... IMPDH1(3614), IMPDH2(3615)

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General description

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.

Application

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 Actions

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.
Mycophenolate mofetil is a prodrug of mycophenolic acid and potent immunosuppresive agent.

Analysis Note

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

Other Notes

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.
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.
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.

signalword

Danger

Hazard Classifications

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

Clase de almacenamiento

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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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)
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)
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
Andrew Bentall et al.
Transplantation, 98(10), 1089-1096 (2014-06-10)
ABO-incompatible kidney transplantations (ABOiKTxs) seem to have better long-term outcomes than positive crossmatch kidney transplantations (+XMKTxs). This study aimed to assess the differences in chronic injury on histologic findings on 1- and 5-year surveillance biopsies and the clinical outcomes in
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