Tacrolimus Rearrangement Lactone

Tacrolimus Rearrangement Lactone - Names and Identifiers

Name	(E/Z)-FK-506 26,28-Allylic Ester Rearrangement Impurity
Synonyms	Tacrolimus Impurity 2 Tacrolimus Impurity 21 Tacrolimus Rearrangement Lactone [3R-[3R(1R,3R,4R),4E,6S,7S,10R,11E,14S,16S,17R,18S,20R,21R,28aS]]- [3R-[3R(1R,3R,4R),4E,6S,7S,10R,11E,14S,16S,17R,18S,20R,21R,28aS]]-7,8,10,13,14,15,16,17,18,19,20,21,26,27,28,28a-Hexadecahydro-7,21-dihydroxy-3-(4-hydroxy-3-methoxycyclohexyl)-16,18-dimethoxy-4,6,12,14,20-pentamethyl-10-(2-propenyl)-7,21-epo 17,21-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclopentacosine-1,9,22,23(6H,25H)-tetrone, 7,8,10,13,14,15,16,17,18,19,20,21,26,27,28,28a-hexadecahydro-7,21-dihydroxy-3-(4-hydroxy-3-methoxycyclohexyl)-16,18-dimethoxy-4,6,12,14,20-pentamethyl-10-(2-propenyl)-, [3R-[3R(1R,3R,4R),4E,6S,7S,10R,11E,14S,1...
CAS	131944-48-4

Tacrolimus Rearrangement Lactone - Physico-chemical Properties

Molecular Formula	C44H69NO12
Molar Mass	804.02
Density	1.19±0.1 g/cm3(Predicted)
Melting Point	115-120°C
Boling Point	879.7±75.0 °C(Predicted)
pKa	9.98±0.70(Predicted)
Storage Condition	-20°C Freezer

Tacrolimus Rearrangement Lactone - Introduction

Tacrolimus impurity 13, also known as fujimycin impurity C, is a chemical compound that is categorized as an impurity of tacrolimus. Tacrolimus, also known by the brand name Prograf, is an immunosuppressive drug commonly prescribed to prevent organ rejection in patients who have undergone a transplant surgery.

Impurities in pharmaceutical drugs refer to substances that are present in the final drug product but are not the desired therapeutic compound. These impurities may arise during the manufacturing process or can be degradation products that form over time. Understanding and monitoring the levels of impurities in a drug is crucial for ensuring its safety, efficacy, and quality.

Tacrolimus impurity 13 or fujimycin impurity C is one of the known impurities that can be present in tacrolimus. It is important to control the levels of this impurity, as it can impact the drug's stability, potency, and potential side effects. Impurity profiling and analysis methods are employed to identify and quantify impurities, including impurity 13, in pharmaceutical formulations.

Regulatory authorities such as the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) have established guidelines regarding the acceptable limits of impurities in pharmaceuticals, including tacrolimus. Manufacturers of drug products are required to adhere to these guidelines and ensure that the levels of impurities, including impurity 13, are within the acceptable thresholds to guarantee the drug's safety and efficacy.

Last Update：2024-04-09 02:00:11