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PHR1613

Levothyroxine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(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

Linear Formula:
HOC6H2(I)2OC6H2(I)2CH2CH(NH2)CO2H
CAS Number:
51-48-9
Molecular Weight:
776.87
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823509
EC Number:
200-101-1
Beilstein/REAXYS Number:
2228515
MDL number:
MFCD00002595
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grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. L0570000, traceable to USP 1365000

API family

levothyroxine

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

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

human ... THRA(7067), THRB(7068)

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 and EP primary standards, where they are available.

Other Notes

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.
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.
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.

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pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H372

Hazard Classifications

STOT RE 1

target_organs

Thyroid,Cardio-vascular system,Kidney

Storage Class

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品

This item has

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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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)
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)

Global Trade Item Number

SKUGTIN
PHR1613-1G04061834793045