PHR1451

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
• 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

Properties

• 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)

Description

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.

Safety Information

• Pictograms: GHS08,GHS07,GHS09
• Signal Word: Danger
• Hazard Statements: H302,H360D,H372,H410
• Precautionary Statements: P202 - P260 - P264 - P273 - P301 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 1
• Storage Class Code: 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