PHR1378

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
• Empirical Formula (Hill Notation): C₁₂H₉F₃N₂O₂
• CAS Number: 75706-12-6
• Molecular Weight: 270.21
• MDL number: MFCD00867593
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823355
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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)

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 Information

• Pictograms: GHS06
• Signal Word: Danger
• Hazard Statements: H301,H315,H319,H335
• Precautionary Statements: P261 - P264 - P270 - P301 + P310 - P302 + P352 - P305 + P351 + P338
• 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