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PHR1378 Supelco

Leflunomide

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 5-Methylisoxazole-4-(4-trifluoromethyl)carboxanilide, Leflunomide

  • CAS Number 75706-12-6

  • Empirical Formula (Hill Notation) C12H9F3N2O2

  • Molecular Weight 270.21

  •  MDL number MFCD00867593

  •  PubChem Substance ID 329823355

  •  NACRES NA.24

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Properties

Related Categories Analytical Standards, Analytical/Chromatography, K-O, Pharmaceutical Secondary Standards, Pharmacopeia & Metrological Institutes Standards More...
grade   certified reference material
  pharmaceutical secondary standard
InChI Key   VHOGYURTWQBHIL-UHFFFAOYSA-N
form   neat
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to PhEur Y0000654
  traceable to USP 1356960
storage temp.   2-8°C

Description

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.

Safety & Documentation

Safety Information

Symbol 
GHS06  GHS06
Signal word 
Danger
Hazard statements 
RIDADR 
UN 2811 6.1 / PGIII
WGK Germany 
3

Documents

Certificate of Analysis (COA)

Please Enter a Lot Number
Protocols & Articles
Peer-Reviewed Papers
15

References

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