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PHR1613

Supelco

Levothyroxine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
3-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]-L-alanine, L-Thyroxine, 3,3′,5,5″-Tetraiodo-L-thyronine, T4
Linear Formula:
HOC6H2(I)2OC6H2(I)2CH2CH(NH2)CO2H
CAS Number:
Molecular Weight:
776.87
Beilstein:
2228515
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

223 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur L0570000
traceable to USP 1365000

storage temp.

2-30°C

SMILES string

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

InChI key

XUIIKFGFIJCVMT-LBPRGKRZSA-N

Gene Information

General description

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.

Biochem/physiol Actions

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.

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 LRAC1514 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

13 - Non Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
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)
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)

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