PHR1928

Rosuvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Rosuvastatin calcium salt
• Empirical Formula (Hill Notation): C₄₄H₅₄CaF₂N₆O₁₂S₂
• CAS Number: 147098-20-2
• Molecular Weight: 1001.14
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• 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

Description

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

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.

Safety Information

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