PHR2833

Nilotinib

certified reference material, pharmaceutical secondary standard

• Synonym(s): 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2- pyrimidinyl]amino]-benzamide monohydrochloride monohydrate
• Empirical Formula (Hill Notation): C₂₈H₂₂F₃N₇O · HCl · H₂O
• CAS Number: 923288-90-8
• Molecular Weight: 583.99
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0002097; traceable to USP 1463428
• description: Pharmaceutical Secondary Standard; Certified Reference Material
• API family: nilotinib
• form: solid
• packaging: pkg of 500 mg
• application(s): pharmaceutical small molecule
• storage temp.: 2-8°C
• InChI: 1S/C28H22F3N7O.ClH.H2O/c1-17-5-6-19(10-25(17)37-27-33-9-7-24(36-27)20-4-3-8-32-14-20)26(39)35-22-11-21(28(29,30)31)12-23(13-22)38-15-18(2)34-16-38;;/h3-16H,1-2H3,(H,35,39)(H,33,36,37);1H;1H2
• InChI key: YCBPQSYLYYBPDW-UHFFFAOYSA-N

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

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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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.

Safety Information

• Pictograms: GHS08,GHS09
• Signal Word: Warning
• Hazard Statements: H361d,H410
• Precautionary Statements: P201 - P202 - P273 - P280 - P308 + P313 - P391
• Hazard Classifications: Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable