[KRISTIANA]

hey, Aniela! to put things simply- in the extract of the plant there is an “active ingedient”, namely andrographolide. the company separates it by liquid chromatography ( hplc) and detects by mass spectronomy. that means that they guarantee that the active ingredient is more than 10% in the extract (here you can calculate how much you actually put in your product). not sure about the DM though- the first thought is - the active ingredient is expressed as dry matter ( meaning pure active ingredient, without water or anything else). let me know you need any clarifications!

[KRISTIANA]

Lots of valuable insights already! From my side - more questions than answers but not enough information to be able to help you.

What is the batch size and equipment used in lab scale?

Does the equipment at industrial scale have recirculation loops or is it a tank only? Is the equipment qualified?

Is the batch manufacturing record written properly so that the exact same manufacturing procedure and parameters are executed every time? are the operators trained? can you give an example for speed limits/interval of turbine agitator you have at manufacturing?

Have you defined the cooling rate ( *C/min) in lab scale and compared to industrial scale?

Additionally to the things mentioned above, I would start by checking emulsion droplets of the emulsion in lab vs industrial scale ( before and after reheating to 50*C) and go from there.

[KRISTIANA]

sounds interesting! what is your background and purpose for this project? i am assuming you are working in pharma industry?

i worked a while ago developing topicals with hormones so your question sparks my interest again ????

[KRISTIANA]

hey, Roy!

the allowed concentration differers based on what type of product you are making- from 5% in shower gels to 100% in make-up removers; what are you making? that would be a simple answer - there are other things to consider, like type of dosage form/other ingredients/how often used to assess the safety.

also, check the purity of your D5- D4 is toxic to reproduction and prohibited in cosmetics in EU.

also, keep in mind that D5 will be reevaluated in the near future and some things may change.

happy formulating !