Name | Tacrolimus Impurity 21(Tacrolimus 21-Carboxy Acid Impurity) |
Synonyms | Tacrolimus Impurity 21 Tacrolimus 21-Carboxy Acid Impurity |
Molecular Formula | C44H71NO13 |
Molar Mass | 822.05 |
Tacrolimus impurity 21, also known as tacrolimus 21-carboxylic acid impurity, is a chemical compound that belongs to the class of impurities or degradation products of the immunosuppressant drug tacrolimus. Tacrolimus, also known as FK506, is commonly used to prevent organ rejection in organ transplant patients.
Impurity 21 refers to the presence of a specific chemical compound, which is a derivative or byproduct that can be found alongside the main active ingredient in the formulation. In this case, it is tacrolimus 21-carboxylic acid impurity, which is a carboxylic acid derivative of tacrolimus.
Impurities in pharmaceutical drugs are typically monitored and regulated to ensure the safety and efficacy of the medication. The presence of impurities can affect the drug's potency, stability, and may even have potential toxic effects. Therefore, manufacturers and regulatory bodies closely analyze and control the levels of impurities in pharmaceutical products.
Understanding the profile of impurities, such as tacrolimus impurity 21, is crucial for pharmaceutical companies to ensure the quality and consistency of their products. This knowledge helps in setting acceptable limits for impurities and developing suitable analytical methods for their detection and quantification.