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PHR1613

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Levothyroxine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

L-Thyroxine, 3,3′,5,5″-Tetraiodo-L-thyronine, 3-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]-L-alanine, T4

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About This Item

Formule linéaire :
HOC6H2(I)2OC6H2(I)2CH2CH(NH2)CO2H
Numéro CAS:
Poids moléculaire :
776.87
Numéro Beilstein :
2228515
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. L0570000
traceable to USP 1365000

Famille d'API

levothyroxine

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Pf

223 °C (dec.) (lit.)

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(O)=O

InChI

1S/C15H11I4NO4/c16-8-4-7(5-9(17)13(8)21)24-14-10(18)1-6(2-11(14)19)3-12(20)15(22)23/h1-2,4-5,12,21H,3,20H2,(H,22,23)/t12-/m0/s1

Clé InChI

XUIIKFGFIJCVMT-LBPRGKRZSA-N

Informations sur le gène

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Description générale

Levothyroxine is a thyroid hormone that is responsible for the physiological actions such as growth, cardiac functionality, and regulation of carbohydrates, lipid, and protein metabolisms.
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.

Application

Levothyroxine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations and bulk dosage forms and oral liquid formulations by chromatography.
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.

Actions biochimiques/physiologiques

L-Thyroxine (T4) and triiodo-L-thyronine (T3) are iodine-containing hormones produced from thyroglobulin in the thyroid follicular cells. The stimulation of metabolic rate and regulation of growth and development by these hormones appear to be due to their effects on DNA transcription and, thus, protein synthesis.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC1514 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

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.

Pictogrammes

Health hazard

Mention d'avertissement

Danger

Mentions de danger

Classification des risques

STOT RE 1

Organes cibles

Thyroid,Cardio-vascular system,Kidney

Code de la classe de stockage

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Consulter la Bibliothèque de documents

Oral liquid formulation of levothyroxine is stable in breakfast beverages and may improve thyroid patient compliance
Bernareggi A, et al.
Pharmaceutics, 5(4), 621-633 (2013)
The separation and determination of liothyronine and levothyroxine in tablets by reversed-phase high performance liquid chromatography
Smith DJ, et al.
Journal of Chromatographic Science, 19(2), 72-78 (1981)
Determination of liothyronine and levothyroxine in thyroid preparations by liquid chromatography
Richheimer SL and Jensen CB
Journal of Pharmaceutical Sciences, 75(2), 215-217 (1986)

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