Technical Resources
Adding a Second API Source: What Your QA Depart...
Comparative batch data, a declaration that nothing changed, and for an animal-derived substance a TSE position. Here is what a second source generates before anyone can use it.
Adding a Second API Source: What Your QA Depart...
Comparative batch data, a declaration that nothing changed, and for an animal-derived substance a TSE position. Here is what a second source generates before anyone can use it.
Incoming Testing of an API: Why Every Container...
The container-by-container identity rule is the default, and the route to being exempt from it runs through supplier audits rather than certificates. What that means if you buy through a...
Incoming Testing of an API: Why Every Container...
The container-by-container identity rule is the default, and the route to being exempt from it runs through supplier audits rather than certificates. What that means if you buy through a...
Re-test Period vs Shelf Life: What a COA Date R...
The re-test date does not mean the material has gone off. It means you owe it a full analysis before you use it. Here is where the number comes from...
Re-test Period vs Shelf Life: What a COA Date R...
The re-test date does not mean the material has gone off. It means you owe it a full analysis before you use it. Here is where the number comes from...
Bile Acid Reference Standards: CRS, USP RS and ...
Four pharmacopoeial standards cover the whole UDCA monograph. Everything else in the impurity list you have to characterise yourself, and how you do that decides whether your limits mean anything.
Bile Acid Reference Standards: CRS, USP RS and ...
Four pharmacopoeial standards cover the whole UDCA monograph. Everything else in the impurity list you have to characterise yourself, and how you do that decides whether your limits mean anything.
Nitrosamine Risk Assessment for APIs: What Buye...
The structural argument that answers most nitrosamine questionnaires on a bile acid, the numbers buyers quote at you, and the four places a small-molecule nitrosamine can still arrive from.
Nitrosamine Risk Assessment for APIs: What Buye...
The structural argument that answers most nitrosamine questionnaires on a bile acid, the numbers buyers quote at you, and the four places a small-molecule nitrosamine can still arrive from.
Elemental Impurities Under ICH Q3D: Where They ...
Not a number on a certificate. A framework that asks which elements can be present, and why — and for a bile-acid API the answer splits into what the material...
Elemental Impurities Under ICH Q3D: Where They ...
Not a number on a certificate. A framework that asks which elements can be present, and why — and for a bile-acid API the answer splits into what the material...