Product Name:Levothyroxine sodium
CAS:55-03-8
MF:C15H20I4NNaO9
MW:888.93
EINECS:200-221-4
Mol File:55-03-8.mol Melting point:207-210 (dec.)(lit.)
alpha D20 -4.4° (c = 3 in 70% ethanol)
Density d420 2.381
storage temp. 2-8°C
Thyroxine Soduim Salt is one of the thyroid hormones involved in the maintenance of metabolic homeostasis. Synthesized and stored as amino acid residues of thyroglobulin, the major protein component of the thyroid follicular colloid. Synthesis and secretion are regulated by the pituitary hormone (TSH). Deiodinated in peripheral tissues to the active metabolite, liothyronine
This product is thyroid hormone replacement therapy. Function and application: It is a synthetic sodium salt of IV-thyronine. Its function and application are similar to that of thyroid tablets. Its oral absorption is 50%, its onset is slow, steady and similar to physiological hormone, which is suitable for the substitution therapy of thyroid hormone. For simple goiter, and thyroidectomy after taking, can prevent the recurrence of goiter, but also can be used as a variety of causes of hypothyroidism and other supplementary treatment.
| Characteristics |
White or pale yellow crystalline powder |
Complies |
| Identification |
By IR |
Complies |
|
By HPLC |
Complies |
| Solubility |
Soluble in acid and alkali solution and water, slightly soluble in ethanol, insoluble in chloroform and ether |
Complies |
| Specific Rotation |
-5.0°~-6.0° |
-5.2° |
| Water Content |
≤11.0% |
7.2% |
| Iodides Content |
≤0.08% |
Complies |
| Related Substances |
Liothyronine: ≤2.00% |
0.20% |
|
N-Acetyl-T4: ≤0.20% |
0.10% |
|
Any other individual impurity: ≤0.50% |
Complies |
|
Total Impurities: ≤2.00% |
1.08% |
Assay
(HPLC basis on drying) |
97.0%~103.0% |
99.7% |
| Reference Standard |
In-house Standard |
| Conclusion |
The product complied to In-house standard. |
| Storage |
Preserve in tight,light-resistant containers in a cool place |
