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PHR1451

Supelco

Mycophenolate Mofetil

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

Empirical Formula (Hill Notation):
C23H31NO7
CAS Number:
128794-94-5
Molecular Weight:
433.49
MDL number:
MFCD00867568
UNSPSC Code:
41116107
PubChem Substance ID:
329822611
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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+

InChI key

RTGDFNSFWBGLEC-SYZQJQIISA-N

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.

Analysis Note

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

Other Notes

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.

Footnote

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.

Recommended products

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.

related product

Product No.
Description
Pricing

1448956

Mycophenolate mofetil, United States Pharmacopeia (USP) Reference Standard

Y0000489

Mycophenolate mofetil, European Pharmacopoeia (EP) Reference Standard

Y0000519

Mycophenolate mofetil for peak identification, European Pharmacopoeia (EP) Reference Standard

1448967

Mycophenolate Mofetil Related Compound A, United States Pharmacopeia (USP) Reference Standard

1448978

Mycophenolate Mofetil Related Compound B, United States Pharmacopeia (USP) Reference Standard

1448989

Mycophenolate sodium, United States Pharmacopeia (USP) Reference Standard

Y0002200

Mycophenolate for system suitability, European Pharmacopoeia (EP) Reference Standard

PHR2776

Mycophenolate Mofetil Related Compound B, Pharmaceutical Secondary Standard; Certified Reference Material, pkg of 100 mg

PHR3211

Mycophenolate Sodium, pharmaceutical secondary standard, certified reference material

Signal Word

Danger

Hazard Statements

H302,H360D,H372,H410

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD2811
LRAC8787
LRAD1002
LRAB3535
LRAA2844

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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)
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
K Budde et al.
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 14(12), 2796-2806 (2014-10-04)
This Phase III randomized trial examined efficacy and safety of a novel once-daily extended-release tacrolimus formulation (LCP-Tacro [LCPT]) versus twice-daily tacrolimus in de novo kidney transplantation. Primary efficacy end point was proportion of patients with treatment failure (death, graft failure
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