In this section, we list the procedures to follow to optimize purification strategies.
What is Active Pharmaceutical Ingredient
You’re probably familiar with the term “active ingredient.” However, did you know that there is another term for the component of a drug product that produces the intended effects? This second term is “Active Pharmaceutical Ingredient (API).”
What can help in the API purification method?
Tayan’s Acu Process Manufacturing (APM) helps in maintaining a rigorous focus on quality control, beginning with the purification of active pharmaceutical ingredients. To ensure purity levels in APM, generic APIs, and custom chemicals, are tracked and identified as an advanced purification processes controller stage.
What is crystallization and how does it help to purify API?
Crystallization is a key unit operation and an important step in processing and development within the pharmaceutical industry, but many experts are uncertain about its precise role, despite the fact that it’s used in the separation and purification of intermediate compounds and Active Pharmaceutical Ingredients (APIs) . Tayana’s APM, tracks, and alerts. The most common and effective method for purifying solids is crystallization.
The Process of crystallization
This involves finding a solvent in which the solid to be purified is insoluble at room temperature but freely soluble once the solution is heated to an elevated temperature.
The solid is brought to a boil in the solvent and then cooled. This causes the compound to crystallize out into a pure form, and any impurities will remain in what’s left of the liquid (also called “mother liquor”).
In order to purify compounds, scientists repeatedly crystallize them until they are of the desired purity. Many times, a single crystallization can provide greater than 99% pure compounds, but if a solid is too soluble at room temperature in a chosen solvent, then a mixed solvent system is used whereby another solvent (anti-solvent) is added to the system.
How are API purifications done?
For example, some amine salts can be purified using both alcohol and ether solvents at the same time. First, dissolve the salt in as little alcohol as possible. Then slowly add the ether solvent until crystallization begins. If that fails, try washing the solid with either a hot or room temperature solvent in which the compound is insoluble, but in which impurities are soluble to a much greater degree. Repeated washing or trituration can be used to enrich the purity of a solid.
API purification techniques
To purify a compound, use techniques such as distillation and chromatography. Distillation involves boiling off the solvent to leave a pure compound. Chromatography uses the different affinities compounds have to either a stationary phase (like silica gel) or a mobile phase (like water) to separate compounds.
These techniques have given way to automated systems, like Bio tags and Teledyne-Isco instruments, that are used for the rapid purification of compounds. Automated HPLC instruments are also used at times; these either use normal phase (silica gel) or reverse-phase columns.
When you purify your product, make sure to use the most appropriate process for your particular needs. Stay committed to quality, focus on working to meet the highest standards possible in commercial and developmental scale manufacturing activities for life sciences companies around the world.
Conclusion for decision
To execute the API purification, you need to track, monitor, and maintain the manufacturing process, there comes our cloud ERP software Acu Process Manufacturing (APM). It’ll be your best investment to expedite your API business. To get a complete demo, CONNECT NOW.
Sangeetha brings 20 years of experience in Information Technology which includes Solution architecting, building micro services, research, and evaluation of business applications, integrating apps.