PHR1928

Rosuvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinónimos: Rosuvastatin calcium salt
• Fórmula empírica (notación de Hill): C₄₄H₅₄CaF₂N₆O₁₂S₂
• Número de CAS: 147098-20-2
• Peso molecular: 1001.14
• UNSPSC Code: 41116107
• NACRES: NA.24

Propiedades

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. Y0001719; traceable to USP 1606015
• API family: rosuvastatin
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• application(s): pharmaceutical
• storage temp.: -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
• InChI key: LALFOYNTGMUKGG-BGRFNVSISA-L

Descripción

General description

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

Analysis Note

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

Footnote

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.

Recommended products

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Información de seguridad

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable