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Key Documents

PHR1540

Supelco

Letrozole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Letrozole, 4,4′-(1H-1,2,4-Triazol-1-ylmethylene)bisbenzonitrile

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About This Item

Empirical Formula (Hill Notation):
C17H11N5
CAS Number:
Molecular Weight:
285.30
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000685
traceable to USP 1356971

API family

letrozole

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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General description

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.
Letrozole is used for the treatment of breast cancer in hormone-dependent postmenopausal patients. The drug works by blocking the synthesis of estrogen, a causative agent for cancer.[1]

Application

Letrozole may be used as a pharmaceutical reference standard for the determination of the analyte in biological/environmental samples[1][2] and pharmaceutical formulations[3] by various chromatography 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.

Biochem/physiol Actions

Letrozole is a third generation nonsteroidal aromatase inhibitor. It is a competitive inhibitor of the aromatase enzyme system and thus inhibits the conversion of androgens to estrogens. Letrozole inhibits the aromatase enzyme by competitively binding to the heme of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAA4186 in the 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.

Pictograms

Health hazard

Signal Word

Warning

Hazard Statements

Hazard Classifications

Repr. 2 - STOT RE 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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    Determination of letrozole in tablet formulations by reversed phase high performance liquid chromatography
    Ganesh M, et al.
    Tropical Journal of Pharmaceutical Research, 9(5), 505-510 (2010)
    Rapid quantitative analysis of letrozole, fluoxetine and their metabolites in biological and environmental samples by MEKC
    Rodriguez?Flores, et al.
    Electrophoresis, 30(4), 624-632 (2009)
    Rapid determination of letrozole, citalopram and their metabolites by high performance liquid chromatography-fluorescence detection in urine: Method validation and application to real samples
    Rodriguez J, et al.
    Journal of Chromatography. B, Biomedical Sciences and Applications, 913, 12-18 (2013)
    Adina Dumitrescu et al.
    Endocrinology, 155(12), 4774-4784 (2014-09-24)
    We have previously shown that estrogen selectively suppresses growth of the fetal zone of the baboon fetal adrenal cortex, which produces the C19-steroid precursors, eg, dehydroepiandrosterone sulfate, which are aromatized to estrogen within the placenta. In the present study, we
    L Zhou et al.
    Journal of neuroendocrinology, 26(7), 439-447 (2014-05-02)
    During the oestrus cycle, varying spine synapse density correlates positively with varying local synthesis of oestradiol in the hippocampus. In this context, the roles of the oestrogen receptor (ER) subtypes ERα and β are not fully understood. In the present

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