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Merck
CN

PHR1378

来氟米特

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

来氟米特, 5-甲基异恶唑-4-(4-三氟甲基)羧基苯胺

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关于此项目

经验公式(希尔记法):
C12H9F3N2O2
化学文摘社编号:
分子量:
270.21
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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产品名称

来氟米特, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C12H9F3N2O2/c1-7-10(6-16-19-7)11(18)17-9-4-2-8(3-5-9)12(13,14)15/h2-6H,1H3,(H,17,18)

SMILES string

Cc1oncc1C(=O)Nc2ccc(cc2)C(F)(F)F

InChI key

VHOGYURTWQBHIL-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000654
traceable to USP 1356960

API family

leflunomide

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

Gene Information

human ... DHODH(1723)

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Analysis Note

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

Application

Leflunomide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.
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.

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. Leflunomide belongs to the new class of immunomodulating drugs with inflammatory and immunomodulating properties. It has been investigated for application in transplantation procedures. It is also an anti-rheumatic drug (DMARD) used to treat rheumatoid arthritis (RA). Its mode of action involves the inhibition of T-cell proliferation after converting to its active metabolite i.e. A771726 in humans.

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.
To see an example of a Certificate of Analysis for this material enter LRAA1634 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbones

signalword

Danger

Hazard Classifications

Acute Tox. 3 Oral - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

target_organs

Respiratory system

存储类别

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

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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Development of liquid chromatography?UV method for simultaneous determination of leflunomide and NSAIDS in API and pharmaceutical formulations: its application to in vitro interaction studies
Sultana N, et al.
Medicinal Chemistry, 3, 262-270 (2013)
Development and Validation of a liquid chromatographic method for the determination of leflunomide: application to in vitro drug metal interactions
Sultana N, et al.
Chin. J. Chem., 29(9), 1933-1938 (2011)
Alan S Boyd
Journal of the American Academy of Dermatology, 66(4), 673-679 (2011-10-04)
Leflunomide is an oral disease-modifying antirheumatic drug administered to patients with rheumatoid and psoriatic arthritis. This drug inhibits dihydroorotate dehydrogenase, an enzyme critical in the production of intracellular pyrimidines, and down-regulates tumor necrosis factor-alfa activity. Leflunomide has demonstrated usefulness in
Allison Ducharme-Smith et al.
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 34(2), 222-226 (2014-12-30)
BK polyomavirus (BKV) infection and nephropathy complicate renal allografts; however, their effect in the native kidneys of pediatric heart transplant (HTx) recipients is unknown. We assessed the prevalence of BKV infection and its association with kidney dysfunction in survivors of
Virendra N Sehgal et al.
The Journal of dermatological treatment, 24(2), 89-95 (2011-08-02)
Leflunomide, an isoxazole derivative, is a disease-modifying antirheumatic drug. It has successfully been used for the treatment of rheumatoid arthritis as a feasible alternative to methotrexate. Recently, leflunomide has been used in certain dermatologic conditions. Medline/PubMed search revealed only 201

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