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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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:
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.
signalword
Danger
hcodes
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
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)
Nicola Alcorn et al.
Drug safety, 32(12), 1123-1134 (2009-11-18)
Evidence is accumulating for the early sustained usage of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis. Leflunomide was licensed for the treatment of rheumatoid arthritis in 1998. Postmarketing surveillance, case reports and observational studies have highlighted less common or unexpected
Shigeko Inokuma
Expert opinion on drug safety, 10(4), 603-611 (2011-03-18)
Although disease-modifying antirheumatic drugs (DMARDs) are crucial for rheumatoid arthritis (RA) therapy, they have severe adverse events including interstitial pneumonitis (IP). DMARD-induced IP attracts attention because of its relatively high prevalence, occasionally fatal outcome and clinical features which are common
Frank Behrens et al.
Current opinion in rheumatology, 23(3), 282-287 (2011-03-24)
Leflunomide is often used as a first choice disease-modifying antirheumatic drug after methotrexate. New data are available for efficacy and safety in both, monotherapy and combination with biologicals. New data on efficacy demonstrate comparable effect sizes for leflunomide and methotrexate
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