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Merck
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Key Documents

PHR1378

Supelco

Leflunomide

Pharmaceutical Secondary Standard; Certified Reference Material

동의어(들):

Leflunomide, 5-Methyl-N-[4-(trifluoromethyl) phenyl]-isoxazole-4-carboxamide, 5-Methylisoxazole-4-(4-trifluoromethyl)carboxanilide

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About This Item

실험식(Hill 표기법):
C12H9F3N2O2
CAS Number:
Molecular Weight:
270.21
MDL number:
UNSPSC 코드:
41116107
PubChem Substance ID:
NACRES:
NA.24

Grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000654
traceable to USP 1356960

API family

leflunomide

CofA

current certificate can be downloaded

기술

HPLC: suitable
gas chromatography (GC): suitable

응용 분야

pharmaceutical (small molecule)

형식

neat

저장 온도

2-8°C

SMILES string

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

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)

InChI key

VHOGYURTWQBHIL-UHFFFAOYSA-N

유전자 정보

human ... DHODH(1723)

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일반 설명

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.

애플리케이션

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.

분석 메모

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

기타 정보

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.

각주

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.

픽토그램

Skull and crossbones

신호어

Danger

유해 및 위험 성명서

Hazard Classifications

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

표적 기관

Respiratory system

Storage Class Code

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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시험 성적서(COA)

Lot/Batch Number

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문서 라이브러리에서 최근에 구매한 제품에 대한 문서를 찾아보세요.

문서 라이브러리 방문

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)
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)
Ora Singer et al.
Current opinion in rheumatology, 23(3), 288-292 (2011-03-08)
To review the recent efficacy and safety data comparing methotrexate (MTX) and leflunomide (LEF) monotherapy, in combination with biologic therapies and in combination with each other. MTX is the 'anchor drug' in all rheumatoid arthritis treatment strategies. Patients with contraindications
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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