Levothyroxine Sodium API
CAS.NO:55-03-8
structural formula:C15H12I4NNaO4
EINECS.no:200-221-4
Other names:L-Thyroxine SodiuM Salt Pentahydrate;Levothyroxine sodium;Levothyroxine Sdium;levothyroxine sodium anhydrous
Test Method:HPLC/UV/GC-MS
MOQ & Package: 10g,100g,1kg,5kg,10kg,25kg etc
Customer's rights and interests:Over 10kg, you can enjoy the service of giving away free samples.
Certificate：FDA,ISO,COA, HPLC, MSDS,TDS etc
Lead Time: 1-3 days
Shipping: DHL,Germany DHL,Germany DPD,UPS,USPS,FedEx,EMS,By Air,By Sea,multimodal transport etc
Store & Shelf life; Cool & dry place; 36 months
Company advantages: there are self-built overseas warehouses and third-party overseas warehouses on all continents.
- Product Description
Xi'an Faithful BioTech Co., Ltd: Your Trusted Levothyroxine Sodium API Manufacturer & Supplier
Levothyroxine Sodium API powder is an artificially synthesized thyroid hormone (T4), whose chemical structure is identical to the thyroid hormone secreted by the human body itself. It is a hormone replacement therapy drug aimed at supplementing or replacing thyroid hormones that the human body cannot produce in sufficient quantities, in order to restore normal metabolic levels. The Sodium levothyroxine Xi'an Faithful BioTech Co., Ltd provide can be converted into triiodothyronine (T3) in the body to enhance activity, and has more significant effects in maintaining normal growth and development, promoting metabolism, increasing heat production, and improving sympathetic adrenal system sensitivity.
Levothyroxine Sodium API powder Introduction
The mechanism by which Levothyroxine Sodium API powder acts in vivo is identical to that of endogenous thyroid hormones, converting into triiodothyronine (T3) and enhancing its activity. It has the following main functions:
1.Alternative function: Directly supplementing the body's deficiency of T4. We know that thyroid dysfunction can cause cretinism, where patients have short stature, thick limbs, slow development, and low intelligence. When adult thyroid dysfunction occurs, it can cause myxoedema
2.Conversion effect: In tissues such as the liver and kidneys, T4 is converted into the more active triiodothyronine (T3), which increases the sensitivity of the sympathetic adrenal system, promotes the metabolism of proteins, carbohydrates, and fats, and thus plays a role in various organs and tissues throughout the body.
3.Regulating metabolism: Calcitonin is a key hormone that maintains normal metabolism, growth and development (especially in children), and energy production in the human body. It affects the function of almost all organs such as the heart, muscles, brain, digestive system, etc. Studies have shown that sufficient thyroid hormones have an increased heart rate and positive inotropic effect on the heart, as well as an increase in cardiac output, regulation of catecholamines, and control of normal breathing
Specifications
Item | Specifications | Results |
Appearance | White or light yellow powder | Complies |
Identification（IR/HPLC） | Corresponds qualitatively to the reference | Complies |
Melting Point | 200°C -215°C | 208°C |
PH | 8.00-10.00 | 9.31 |
Residue on Ignition | ≤0.1% | 0.03% |
Heavy Metal | ≤20ppm | <10ppm |
Fe(%) | ≤ 0.002 | 0.005 |
sodium carbonate(%) | ≤ 0.1 | 0.01 |
sodium sulfate(%) | ≤ 0.1 | 0.02 |
Chloride(%) | ≤ 0.1 | 0.05 |
Solubility(Cell culture) | 1mg/mL≤ X ≤ 0.01 mg/mL | 0.1mg/mL |
Standard Plate Count | ≤800cfu/g | 88cfu/g |
Yeast & Mold | ≤100cfu/g | 10cfu/g |
Coliforms | ≤3cfu/g | 0.1cfu/g |
E. Coli | Negative/10g | Negative |
Salmonella | Negative/25g | Negative |
S.aureus | Negative/25g | Negative |
Purity | 98.0%-100.0% | 98.8% |
| Conclusion： | Conform with enterprise specification （USP 41）. |
Why Choose Us?
Levothyroxine sodium is a pharmaceutical ingredient with a narrow therapeutic window, so its requirements are relatively high.
1. Bioequivalence and clinical validation:
Our company's Levothyroxine Sodium API powder has undergone rigorous bioequivalence studies with the original raw material, and the data fully demonstrates that its absorption degree and speed in vivo are not clinically different from the original drug. This means that doctors and patients can have the same confidence in the efficacy and safety of our product as the original drug. ”
2. Excellent production technology and quality control:
Although the chemical structure of levothyroxine sodium is simple, its production, especially the precision and stability of dosage, is a huge technical challenge. We have adopted internationally advanced production lines and fully automated quality control systems to ensure that the drug content in each batch is precise and stable, avoiding the risk of poor efficacy or palpitations caused by dosage fluctuations
3. Strict raw material control:
We control quality from the source, have extremely strict audits and standards for raw material suppliers, ensure high purity and low impurities of active ingredients, and guarantee the safety and reliability of products from the first process
4. Professional academic support:
We not only provide products, but also strive to become partners for doctors in the field of thyroid diseases. We have a professional medical team that can provide professional academic support such as interpreting the latest diagnosis and treatment guidelines, sharing clinical cases, etc., to help doctors improve their diagnosis and treatment level
5. Patient Education and Care Program:
Our platform often publishes the latest pharmacological knowledge, pharmaceutical news, covering disease knowledge, medication guidance, lifestyle advice, etc. Through these efforts, we hope to help patients better manage their own health and establish long-term trust relationships
6. Reliable supply chain guarantee:
We have a mature and stable supply chain and a nationwide distribution network, which can ensure the continuous and stable supply of drugs and avoid patients from interrupting treatment due to drug discontinuation. This is the lifeline to ensure the continuity of treatment for chronic disease patients
Our email is: sales8@faithfulbio.com，If you are interested in learning about sodium Levothyroxine API, please leave a message
Characteristics of Interaction
Sodium levothyroxine interacts with various pharmaceutical ingredients:
Enhancing effect: increases anticoagulant activity and raises Phenytoin sodium levels in the blood
Reduced absorption: CHOLESTYLAMINE RESIN, aluminum/iron/calcium containing preparations can reduce gastrointestinal absorption
Metabolic effects: Rifampicin and carbamazepine can accelerate metabolism and reduce therapeutic efficacy.
Quality Control:
R&D Results:
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FAQ
Q1. What causes feeling palpitations, insomnia, and sweating?
This is usually an excessive manifestation that leads to hyperthyroidism reactions. Please contact your doctor promptly for a follow-up check of thyroid function, as it may be necessary to reduce the dosage appropriately.
Q2. Will it harm the liver and kidneys?
Under the guidance of a doctor, an appropriate dose of levothyroxine sodium is safe. It is a hormone secreted by the human body itself, and the purpose of replacement therapy is to "supplement what is lacking", so it usually does not cause damage to liver and kidney function. But regular check ups are not only for TSH, but also for monitoring other physical indicators, which is the key to ensuring long-term safety.
Q3. Does it make people gain weight?
On the contrary. Sodium Levothyroxine is used to treat hypothyroidism, which itself can lead to slowed metabolism and weight gain. Medication is taken to restore thyroid function to normal levels, thereby restoring normal metabolic rate. Therefore, taking medication correctly can help restore normal weight. If there is an abnormal increase in weight after taking medication, it may be due to insufficient dosage and requires a re examination of thyroid function.
Contact us
Levothyroxine Sodium API needs to be stored under light shielding and sealed below 25 ℃, with a shelf life of usually 18-36 months. When you open it, it is not advisable to store it for more than 3 months. In hot summer weather, it is necessary to seal it and store it in the refrigerator. If you need to learn more about the characteristics of L-Thyroxine SodiuM Salt Pentahydrate or need to study materials, please leave me a message Our email address is:sales8@faithfulbio.com
