Learn about Levothyroxine impurity and related information. Levothyroxine, or L-thyroxine, is an artificial form of the thyroxine hormone that is used to cure related ailments. The thyroid hormones, triiodothyronine (T3) and thyroxin (T4) are primarily responsible for regulation of metabolism. Tyrosine-based these two hormones are produced by the thyroid gland. Both T3 and T4 are used to treat thyroid hormone deficiency known as hypothyroidism, including the severe form known as myxedema coma. The pharmaceutical name of Levothyroxine sodium (T4) is Levothyroxine more pure, synthetic form of Thyroid.
Introduced in the 1950s Levothyroxine is typically used in the cure for people with hypothyroidism that regularly requires lifelong thyroid hormone remedy. Levothyroxine is also used to treat subclinical hypothyroidism which is defined by araised TSH level and is milder than usual. Such people may be asymptomatic and can’t be predicted whether they should be treated or they don’t require any sort of treatment.
Levothyroxine is contraindicated in the following:
- Levothyroxine degrades rapidly with exposure to light, moisture, and oxygen.
- thyroid disorder called thyrotoxicosis
- sort of heart, coronary artery disease, or any history of blood clots
- diabetes (insulin or oral medication dosages must be changed when you start Levothyroxine medicine)
- low bone mineral density or osteoporosis
- any problems with your pituitary gland
- food or drug allergy
- untreated adrenal gland disorder
- Not suggested in people who have had a recent heart attack.
During the manufacturing process or storage of the drug elements, impurities present in the form of by-products or so called process impurities are possible.
All impurities of Levothyroxine obtained are given below.
- Levothyroxine T4-Amine O-methyl Impurity / O-Methyl-Tetraiodothyroethylamine
- Levothyroxine acetamide Impurities (T4-Acetamide)
- Levothyroxine EP Impurities A, Levothyroxine
- Levothyroxine EP Impurities C, T3-Acetic Acid (USP)
- Levothyroxine EP Impurities D, T4-Acetic Acid (USP)
- Levothyroxine EP Impurities F, Levothyroxine T6 Impurity (USP)
- Levothyroxine EP Impurities H, T4-Benzoic Acid (USP)
- Levothyroxine EP Impurities I, T4-Aldehyde (USP)
- Levothyroxine EP Impurity J, 3,3’-Diiodo-L-Thyronine
- Levothyroxine EP Impurity K, 3,3’,5’-Triiodo-L-Thyronine
- Levothyroxine N-Acetyl Impurities, 1 N-Acetyl-T4 (USP)
- Levothyroxine N-Formyl Impurity,N-Formyl-T4 (USP)
- Levothyroxine N-Methylamide (USP)
- Levothyroxine O-Methyl impurity
- Levothyroxine T4-Hydroxy Acetic Acid Impurities
- Levothyroxine T4-Thyrolactic acid Impurities
Excessive dosages include weight loss, disability in tolerating heat, sweating, anxiety, sleeping problems, shivering, and rise in heartbeat rate. Consult your doctor if you had a recent heart attack, or experience any symptoms of a heart attack such as chest pain or heavy feeling in heart, pain spreading to the shoulder, nausea, sweating or general ill feeling). Consuming this during pregnancy has been found to be safe if recommendation of dosing is based on regular check-ups of TSH and T4 levels in the blood. One benefit of treating this people with Levothyroxine therapy is preventing enhancement of hypothyroidism.
Manufactured Levothyroxine can be efficiently used to treat hyperthyroidism and related symptoms. The process of synthesizing artificial Levothyroxine is well documented and the Levothyroxine impurities are stringent. These are based on the guidelines of the ICH & pharmacopeia.