Hangzhou ZeErRui Chemical Co., Ltd.
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CAS NO.25416-65-3
|
Product Name |
Levothyroxine Sodium |
|
CAS No |
25416-65-3 |
|
Molecular Weight |
798.85 |
|
Batch No |
ZERLS20190116 |
|
Manufacturing date |
20190116 |
|
Shelf life |
2 years |
|
Index Name |
Specification |
Result |
|
Appearance |
light yellow to buff-colored, odorless, tasteless, hygroscopic powder, stable in dry air but may assume a slight pink color upon exposure to light. |
almost white Crystalline Powder, odorless, tasteless, hygroscopic, stable in dry air |
|
Identification 1) Iodine 2) colour |
1) （flame decomposes and liberates iodine vapors） 2) （add solution, a pink colour produced） |
1) Pass 2) 2) pass |
|
solubility |
1) （very slightly soluble in water） 2) （soluble in solutions of Alkalihydroxides and in hot solutions of Alkll carbonates） 3) （slightly solution in Alcohol） 4) （Insoluble in Acetone,chloroform and in Ether） |
1) Pass 2) 2) Pass 3) 3) Pass 4) 4) Pass |
|
Specific rotation [α]D20 |
-5.0～-6.0°(C=3, in 1NNaOH：C2H5OH=1：2) |
-5.5° |
|
Loss on drying |
≤11.0% |
10.2% |
|
Assay |
98.5-103.0% |
99.18% |
|
Purity |
≥98.5% |
99.6% |
|
Inorganic iodides |
≤0.08% |
<0.08% |
|
Ethanol |
≤0.10% |
0.008% |
|
Liothyronine sodium |
≤2.0% |
0.82% |
|
Conclusion |
Conforms to the standard of USP30 |
|
Levothyroxine is a thyroid medicine that replaces a hormone normally produced by your thyroid gland to regulate the body's energy and metabolism.
Levothyroxine is given when your thyroid does not produce enough of this hormone on its own.
Levothyroxine is used to treat hypothyroidism (low thyroid hormone). It is also used to treat or prevent goiter (enlarged thyroid gland), which can be caused by hormone imbalances, radiation treatment, surgery, or cancer.
Hangzhou ZeErRui Chemical Co., Ltd. is focused on customization, research and development and production of APIs and advanced intermediates, which can effectively compensate for the deficiencies of traditional CRO and CMO. Priority of high-tech barriers, high value-added, low pollution characteristics of the project, landing the project of innovative non patented route design, difficult process development and rapid industrialization. Starting from the advantages of combining technology research and stable production, Lead Biotech cooperated with domestic and foreign large pharmaceutical companies in the development of generic drugs and innovative drugs.
It also has hardware facilities and support teams that match the strength of R & D and production: With LCMS, HPLC and other perfect detection means, professional testing team and perfect quality control system; With a pilot base, a stable GMP standard production capacity, and a new GMP workshop is building; With regular financial, legal ERP system and professional sales and logistics team.
