PHR1285

Lovastatin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Lovastatin, Mevinolin
• Empirical Formula (Hill Notation): C₂₄H₃₆O₅
• CAS Number: 75330-75-5
• Molecular Weight: 404.54
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. L0790000; traceable to USP 1370600
• API family: lovastatin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• InChI: 1S/C24H36O5/c1-5-15(3)24(27)29-21-11-14(2)10-17-7-6-16(4)20(23(17)21)9-8-19-12-18(25)13-22(26)28-19/h6-7,10,14-16,18-21,23,25H,5,8-9,11-13H2,1-4H3/t14-,15-,16-,18+,19+,20-,21-,23-/m0/s1
• InChI key: PCZOHLXUXFIOCF-BXMDZJJMSA-N

Description

General description

Lovastatin, an orally administered drug, is a lactone metabolite used for the treatment of hypercholesterolemia and coronary heart diseases. It is a hexahydronaphtalene drug, belonging to the class of HMG-CoA (3-hydroxy-3-methyl-glutaryl-coenzyme A) reductase inhibitors.
Pharmaceutical secondary standard for application in quality control. Provides pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Lovastatin may find its use as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometric, thermal characterization, and chromatographic techniques.

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 (PhEur) 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3329 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H351,H361f
• Precautionary Statements: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Carc. 2 - Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable