PHR1928

Rosuvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Rosuvastatin calcium salt
• Formule empirique (notation de Hill): C₄₄H₅₄CaF₂N₆O₁₂S₂
• Numéro CAS: 147098-20-2
• Poids moléculaire : 1001.14
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001719; traceable to USP 1606015
• Famille d'API: rosuvastatin
• Forme: powder
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 1 g
• Application(s): pharmaceutical
• Température de stockage: -10 to -25°C
• InChI: 1S/2C22H28FN3O6S.Ca/c2*1-13(2)20-18(10-9-16(27)11-17(28)12-19(29)30)21(14-5-7-15(23)8-6-14)25-22(24-20)26(3)33(4,31)32;/h2*5-10,13,16-17,27-28H,11-12H2,1-4H3,(H,29,30);/q;;+2/p-2/b2*10-9+;/t2*16-,17-;/m11./s1
• Clé InChI: LALFOYNTGMUKGG-BGRFNVSISA-L

Description

Description générale

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.

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.

Rosuvastatin Calcium, an HMG-CoA reductase inhibitor, belongs to the statins class of pharmaceuticals and is used for the treatment of hypercholesterolemia.

Application

This pharmaceutical secondary standard can also be used as follows:

• Spectrophotometric estimation of rosuvastatin calcium in its pure form and tablet formulations
• Determination of rosuvastatin calcium by square-wave voltammetry using a boron-doped diamond electrode in two tablet samples and biological fluid samples of human urine and serum
• Simultaneous quantification of rosuvastatin and amlodipine by high-performance liquid chromatography (HPLC) in combined pharmaceutical formulations
• Determination of rosuvastatin calcium and related substances in tablets of rosuvastatin using a reversed-phase high-performance liquid chromatographic (RP-HPLC) method

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC2081 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Informations sur la sécurité

• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable