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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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)

Description

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.

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.

Safety Information

• Pictograms: GHS08
• Signal Word: Danger
• Hazard Statements: H372
• Precautionary Statements: P260 - P264 - P270 - P314 - P501
• Hazard Classifications: STOT RE 1
• Target Organs: Thyroid,Cardio-vascular system,Kidney
• Storage Class Code: 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