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PHR1378

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Leflunomide

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C12H9F3N2O2
CAS Number:
Molecular Weight:
270.21
MDL number:
UNSPSC Code:
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

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

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

Gene Information

human ... DHODH(1723)

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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.

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.

Analysis Note

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

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.

Footnote

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

Signal Word

Danger

Hazard Statements

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


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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)
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
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
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

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