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Safety Information

1356960

USP

Leflunomide

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

5-Methylisoxazole-4-(4-trifluoromethyl)carboxanilide

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About This Item

Empirical Formula (Hill Notation):
C12H9F3N2O2
CAS Number:
75706-12-6
Molecular Weight:
270.21
MDL number:
MFCD00867593
UNSPSC Code:
41116107
PubChem Substance ID:
329750235
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

leflunomide

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

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

Gene Information

human ... DHODH(1723)

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General description

Leflunomide is a drug with cytotoxic properties. It is generally used as an immunosuppressive agent.

Application

Leflunomide USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

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Y0000654

Leflunomide, European Pharmacopoeia (EP) Reference Standard

Y0000674

Leflunomide for peak identification, European Pharmacopoeia (EP) Reference Standard

Y0000487

Leflunomide impurity A, European Pharmacopoeia (EP) Reference Standard

1357045

Leflunomide Related Compound A, United States Pharmacopeia (USP) Reference Standard

1357056

Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard

1357067

Leflunomide Related Compound C, United States Pharmacopeia (USP) Reference Standard

PHR1568

Leflunomide Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

BP1233

Leflunomide, British Pharmacopoeia (BP) Reference Standard

PHR2878

Leflunomide Related Compound B, pharmaceutical secondary standard, certified reference material

Pictograms

Skull and crossbones
GHS06

Signal Word

Danger

Hazard Statements

H301,H315,H319,H335

Hazard Classifications

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

Target Organs

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

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1356960-200MG:

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Lot/Batch Number

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4-(Trifluoromethyl)aniline 99%

Sigma-Aldrich

224936

4-(Trifluoromethyl)aniline

S Greene et al.
Biochemical pharmacology, 50(6), 861-867 (1995-09-07)
Leflunomide [HWA 486 or RS-34821, 5-methyl-N-(4-trifluoromethylphenyl)-4-isoxazole carboximide] is an immunosuppressive agent effective in the treatment of rheumatoid arthritis. In spite of its clinical potential, its mechanism of action has not been elucidated. Recent studies suggest that leflunomide may interfere with
Robert P Baughman et al.
Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG, 21(1), 43-48 (2004-05-07)
Leflunomide (Arava) is a cytotoxic drug which has been used as a single agent or in combination with methotrexate for the treatment of rheumatoid arthritis. It appears to have less toxicity than methotrexate. The use of leflunomide for sarcoidosis patients
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
W James Chon et al.
Expert review of clinical immunology, 7(3), 273-281 (2011-05-21)
Leflunomide is a synthetic isoxazole-derivative drug that possesses both immunosuppressive and antiviral properties. Although its only US FDA-approved indication is for the treatment of rheumatoid arthritis, accumulating clinical experience in addition to animal study data makes it an appealing option
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