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重要文件

PHR1451

Supelco

霉酚酸酯

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

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

經驗公式(希爾表示法):
C23H31NO7
CAS號碼:
分子量::
433.49
MDL號碼:
分類程式碼代碼:
41116107
PubChem物質ID:
NACRES:
NA.24
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等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to Ph. Eur. Y0000489
traceable to USP 1448956

API 家族

mycophenolate

CofA

current certificate can be downloaded

包裝

pkg of 1 g

技術

HPLC: suitable
gas chromatography (GC): suitable

應用

pharmaceutical (small molecule)

形式

neat

儲存溫度

2-30°C

SMILES 字串

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 密鑰

RTGDFNSFWBGLEC-SYZQJQIISA-N

基因資訊

尋找類似的產品? 前往 產品比較指南

一般說明

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.[1]

應用

Mycophenolate Mofetil may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by electrochemical method.[2][3]
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.

生化/生理作用

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.

分析報告

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

其他說明

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.

腳註

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.

推薦產品

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.

訊號詞

Danger

危險分類

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

儲存類別代碼

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

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/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)
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
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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