Technical Resources
Choosing a Third-Party Laboratory: Six Things t...
An accredited laboratory can still be unaccredited for your test, your material or the site that runs it. Six checks against the scope before you outsource a bile-acid assay.
Choosing a Third-Party Laboratory: Six Things t...
An accredited laboratory can still be unaccredited for your test, your material or the site that runs it. Six checks against the scope before you outsource a bile-acid assay.
When the Pharmacopoeia Changes: What Happens to...
Pharmacopoeial monographs are revised on a fixed calendar, and a revision does not force you to scrap released stock. What actually changes, and the two questions to ask your supplier.
When the Pharmacopoeia Changes: What Happens to...
Pharmacopoeial monographs are revised on a fixed calendar, and a revision does not force you to scrap released stock. What actually changes, and the two questions to ask your supplier.
How to Verify a CEP or GMP Certificate: A Buyer...
A signed PDF is not evidence. The certification database, the site annex and a Letter of Access take about five minutes to check, and they answer what a logo and...
How to Verify a CEP or GMP Certificate: A Buyer...
A signed PDF is not evidence. The certification database, the site annex and a Letter of Access take about five minutes to check, and they answer what a logo and...
Microbial Limits and Endotoxin: What a Non-Ster...
Microbial limits and endotoxin sit on the same purchase form but answer different questions, and for a non-sterile oral powder only one of them usually comes from the monograph itself.
Microbial Limits and Endotoxin: What a Non-Ster...
Microbial limits and endotoxin sit on the same purchase form but answer different questions, and for a non-sterile oral powder only one of them usually comes from the monograph itself.
Batch-to-Batch Consistency: Reading Three Conse...
One certificate answers whether a batch passed. Three in a row start to answer whether the process is steady. How to read them as a series, and where the three-batch...
Batch-to-Batch Consistency: Reading Three Conse...
One certificate answers whether a batch passed. Three in a row start to answer whether the process is steady. How to read them as a series, and where the three-batch...
Stability-Indicating Method: Why a Passing Assa...
A passing assay is not proof that the method can see degradation. Two pharmacopoeias measure UDCA content by different principles, and only one of them is chromatographic. How to tell...
Stability-Indicating Method: Why a Passing Assa...
A passing assay is not proof that the method can see degradation. Two pharmacopoeias measure UDCA content by different principles, and only one of them is chromatographic. How to tell...