Leflunomide
SIAL/PHR1378 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Leflunomide; 5-Methyl-N-[4-(trifluoromethyl) phenyl]
CAS Number: 75706-12-6
Empirical Formula (Hill Notation): C12H9F3N2O2
Molecular Weight: 270.21
MDL Number: MFCD00867593
Linear Formula: C12H9F3N2O2
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0000654 |
| traceable to USP 1356960 | |
| API family | leflunomide |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C12H9F3N2O2/c1-7-10(6- |
| InChI key | VHOGYURTWQBHIL-UHFFFAOYSA |
| Quality Level | 300  |
| SMILES string | Cc1oncc1C(=O)Nc2ccc(cc2)C |
| storage temp. | 2-8°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available. |
| Application: | Leflunomide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques. |
| Application: | 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. |
| 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. |
| 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. |
| 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. |
| Symbol |  GHS06 |
| Signal word | Danger |
| Hazard statements | H301 - H315 - H319 - H335 |
| Precautionary statements | P261 - P264 - P270 - P301 + P310 - P302 + P352 - P305 + P351 + P338 |
| Hazard Codes | Xn |
| Risk Statements | 22-36/37/38 |
| Safety Statements | 26 |
| RIDADR | UN 2811 6.1 / PGIII |
| WGK Germany | WGK 1 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-8°C |
| UNSPSC | 41116107 |