Capecitabine
SIAL/PHR1405 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Capecitabine; CAP; 5′-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine; Ro-9-1978
CAS Number: 154361-50-9
Empirical Formula (Hill Notation): C15H22FN3O6
Molecular Weight: 359.35
MDL Number: MFCD00930626
Linear Formula: C15H22FN3O6
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0001642 |
| traceable to USP 1090706 | |
| API family | capecitabine |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C15H22FN3O6/c1-3-4-5-6 |
| InChI key | GAGWJHPBXLXJQN-UORFTKCHSA |
| packaging | pkg of 1 g |
| Quality Level | 300  |
| SMILES string | O[C@H]1[C@@H](O)[C@H](N2C |
| storage temp. | 2-30°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. |
| Application: | Capecitabine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometric 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. |
| Biochem/physiol Actions: | Capecitabine is an anti-cancer drug, a prodrug of doxifluridine, metabolized to 5-fluorouracil at the tumor site. The activation of capecitabine follows a pathway with three enzymatic steps and two intermediary metabolites, 5′-Deoxy-5-fluorocytidine (5′-DFCR) and 5′-Deoxy-5-fluorouridine (5′-DFUR), to form 5-fluorouracil. |
| Footnote: | To see an example of a Certificate of Analysis for this material enter LRAA2199 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. Capecitabine is an orally administered drug belonging to the class of fluoropyrimidine carbamates. It converts into 5-fluorouracil (5-FU) at the tumor tissues by exploiting the high intratumoral concentrations of thymidine phosphorylase. |
| 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 |  GHS08 |
| Signal word | Danger |
| Hazard statements | H341 - H350 - H360FD |
| Precautionary statements | P201 - P308 + P313 |
| Hazard Codes | T |
| Risk Statements | 45-60-61-68 |
| Safety Statements | 53-22-36/37-45 |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |