LEVOTHYROXINE IMPURITIES; MANUFACTURER OLYMPUS CHEMICALS & FERTILIZERS.
Synthesis of Levothyroxine is well documented in lecture and there was continuous improvement in synthesis not only to develop simple route but trying to get commercially feasible process to avoid or minimize the level of any possible impurities.
Related substances or impurities present in the form of by-products or process impurities are possible during the manufacturing process or storage of the drug substances.
The acceptances criteria for these impurities are stringent and based on the ICH & pharmacopeia guidelines. As per stringent regulatory requirement recommended by ICH, the impurities >0.1 must be identified and characterized. Furthermore, it is equally important to have impurity in pure from required for analytical development such as specificity, linearity, accuracy, limit of detection (LOD), limit of quantification (LOQ), robustness and relative retention factor. Easy way to get impurity in pure form is to degrade API products and enriched desired impurity followed by isolation by column or flash chromatography or PREP-HPLC purification depending upon level of impurity present in degrade API. But if impurity is not forming at sufficient level by various degration methods or if it is process related then there is no choice but to plan for synthesis of particular impurity.
We developed r synthesized all impurities of Levothyroxine given below.
1 Levothyroxine T4-Amine O-methyl Impurity / O-Methyl- Tetraiodothyroethylamine
2 Levothyroxine Acetamide Impurities (T4-Acetamide)
3 Levothyroxine EP Impurities A, Levothyroxine
4 Levothyroxine EP Impurities C, T3-Acetic Acid (USP)
5 Levothyroxine EP Impurities D, T4-Acetic Acid (USP)
6 Levothyroxine EP Impurities F, Levothyroxine T6 Impurity (USP)
7 Levothyroxine EP Impurities H, T4-Benzoic Acid (USP)
8 Levothyroxine EP Impurities I, T4-Aldehyde (USP)
9 Levothyroxine EP Impurity J, 3,3’-Diiodo-L-Thyronine
10 Levothyroxine EP Impurity K, 3,3’,5’-Triiodo-L-Thyronine
11 Levothyroxine N-Acetyl Impurities, 1 N-Acetyl-T4 (USP)
12 Levothyroxine N-Formyl Impurity,N-Formyl-T4 (USP)
13 Levothyroxine N-Methylamide (USP)
14 Levothyroxine O-Methyl impurity
15 Levothyroxine T4-Hydroxy Acetic Acid Impurities
16 Levothyroxine T4-Thyrolactic acid Impurities
For details please click – https://olympusimpuritiesstandard.com/