Specification
Items | Specifications | Results |
Appearance | Off-white to white crystalline powder | Conforms |
Identification | A:Infrared Spectroscopy:197K | Positive |
Solubility | Its solutions are practically neutral to litmus.Freely soluble in water,in alcohol(96% ethanol) and in chloroform.Slightly soluble in ether | Conforms |
Loss on drying | ≤0.5% | 0.20% |
Residual on ignition | ≤0.1% | 0.07% |
Organic impurities(GC) | Methimazole related compound A≤0.1% | N.D |
1-Methylimidazole≤0.1% | 0.02% |
Methimazole related compound C≤0.1% | N.D |
Methimazole—N/A | Conforms |
Any other individual impurity≤0.1% | 0.02% |
Total impurities≤0.5% | 0.08% |
Assay | 98.0%-101.0% | 99.8% |
Conclusion | The results of this product comply with the regulations. |
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Methimazole is a prescription medication primarily used to treat hyperthyroidism (overactive thyroid), most commonly caused by Graves' disease. It belongs to a class of drugs known as antithyroid agents.
How It Works: Mechanism of Action
Its primary function is to reduce the production of thyroid hormones by the thyroid gland. It does this by inhibiting the enzyme thyroid peroxidase. This enzyme is essential for incorporating iodine into the amino acid tyrosine to produce the hormones thyroxine (T4) and triiodothyronine (T3). By blocking this process, Methimazole effectively lowers the levels of thyroid hormones in the body.
Key Uses
Management of Hyperthyroidism: It is a first-line treatment to control symptoms and bring hormone levels to a normal range.
Preparation for Thyroid Surgery or Radioactive Iodine Therapy: It is used to stabilize a patient's thyroid function before these more definitive procedures.
Important Safety Information and Side Effects
Methimazole is a potent drug that requires careful medical supervision.
Common Side Effects: Include skin rash, upset stomach, nausea, vomiting, joint and muscle pain, hair loss, and headache.
Serious but Rare Side Effects:
Agranulocytosis: A sudden, severe drop in white blood cells, which can increase the risk of serious infection. Patients must be advised to immediately report any signs of fever, sore throat, or mouth sores.
Liver Toxicity: Can cause hepatitis and liver failure.
Vasculitis: Inflammation of the blood vessels.
Due to a slightly higher risk of birth defects, it is generally not the first-choice antithyroid drug during the first trimester of pregnancy (Propylthiouracil is often preferred).
Chemical Profile
CAS Registry Number: 60-56-0
IUPAC Name: 1-Methyl-3H-imidazole-2-thione
Molecular Formula: C₄H₆N₂S
Summary
In essence, Methimazole is a critical drug for managing an overactive thyroid by directly interfering with the synthesis of thyroid hormones. While highly effective, its use is balanced against the need for regular monitoring due to the potential for serious, though uncommon, side effects.
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