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PHR1285

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Lovastatin

Pharmaceutical Secondary Standard; Certified Reference Material

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

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

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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.

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Description
Pricing

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Lovastatin Related Compound A, United States Pharmacopeia (USP) Reference Standard

L0790000

Lovastatin, European Pharmacopoeia (EP) Reference Standard

Y0001136

Lovastatin for peak identification, European Pharmacopoeia (EP) Reference Standard

1370655

Lovastatin Impurity Identification Mixture, United States Pharmacopeia (USP) Reference Standard

1236833

Lovastatin Epimer Mixture, United States Pharmacopeia (USP) Reference Standard

1443216

Mevastatin, United States Pharmacopeia (USP) Reference Standard

PHR2240

Mevastatin/Lovastatin Impurity A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2278

Lovastatin Impurity C, Pharmaceutical Secondary Standard; Certified Reference Material

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Lovastatin Impurity D, Pharmaceutical Secondary Standard; Certified Reference Material

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Pictograms

Health hazard
GHS08

Signal Word

Warning

Hazard Statements

H351,H361f

Hazard Classifications

Carc. 2 - Repr. 2

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin
Silva TD, et al.
Journal of Chromatographic Science, 50(9), 831-838 (2012)
Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS
Downs JR, et al.
JAMA : The Journal of the American Medical Association, 279(20), 1615-1622 (1998)
Lovastatin decreases coenzyme Q levels in humans.
Folkers K, et al.
Proceedings of the National Academy of Sciences of the USA, 87(22), 8931-8934 (1990)
Comparison of UV and charged aerosol detection approach in pharmaceutical analysis of statins
Novakova L, et al.
Talanta, 78(3), 834-839 (2009)
Colorimetric determination of simvastatin and lovastatin in pure form and in pharmaceutical formulations
El-Din Mohie MKS, et al.
Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy, 76(3-4), 423-428 (2010)
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