Technical Resources
Retention Samples vs Ongoing Stability: Two Pro...
Keeping a sample is not the same as running a programme. One is evidence for a dispute, the other evidence that the process still produces what it did three years...
Retention Samples vs Ongoing Stability: Two Pro...
Keeping a sample is not the same as running a programme. One is evidence for a dispute, the other evidence that the process still produces what it did three years...
Temperature Excursions: When a Spike Still Mean...
An excursion alarm is a question, not a verdict. A batch that spent nine hours at 47 °C inside a sealed laminate is not in the same position as one...
Temperature Excursions: When a Spike Still Mean...
An excursion alarm is a question, not a verdict. A batch that spent nine hours at 47 °C inside a sealed laminate is not in the same position as one...
Zone IVb Stability: Why 30 °C/75% RH Changes th...
Most stability sections are written for the supplier's home market. If your destination sits in Zone IVb, the long-term condition is 30 °C/75% RH, and a 25/60 file answers a...
Zone IVb Stability: Why 30 °C/75% RH Changes th...
Most stability sections are written for the supplier's home market. If your destination sits in Zone IVb, the long-term condition is 30 °C/75% RH, and a 25/60 file answers a...
Photostability of Bile-Acid APIs: What ICH Q1B ...
A photostability study and a "protect from light" label are not the same claim. One is data, the other a handling instruction, and buyers often accept the second in place...
Photostability of Bile-Acid APIs: What ICH Q1B ...
A photostability study and a "protect from light" label are not the same claim. One is data, the other a handling instruction, and buyers often accept the second in place...
Mass Balance: Why Assay, Impurities and Water M...
Add the assay, the impurities and the water and you get something that is not quite one hundred. The residual is not a rounding error. It is a list of...
Mass Balance: Why Assay, Impurities and Water M...
Add the assay, the impurities and the water and you get something that is not quite one hundred. The residual is not a rounding error. It is a list of...
Bulk Density and Flow: What It Costs on a Table...
The certificate says the same D90. The press runs at seventy percent of its usual speed. The difference is in how the powder packs and flows, and it is not...
Bulk Density and Flow: What It Costs on a Table...
The certificate says the same D90. The press runs at seventy percent of its usual speed. The difference is in how the powder packs and flows, and it is not...