Skip to content

Quality and documentation

What is measured on every lot, what is reported, and what happens when a specification has to be met on paper.

Every lot ships with three documents and one retained sample. The documents are a batch certificate
of analysis, a safety data sheet in GHS format, and a specification sheet that an incoming inspection
group can test against without rewriting it.

What the certificate states

Item Method When it is reported
Identity NMR and MS Every lot
Assay GC or HPLC, depending on the compound Every lot
Isomeric ratio GC or HPLC Where the entry is a defined isomer
Impurity profile Same run as the assay On request
Water content Karl Fischer Where the compound is hygroscopic
Residual solvent Headspace GC On request

Assay belongs to the lot, not to the page

No catalogue entry implies a minimum assay unless one is written on the entry. The number that
applies is the one on the certificate for the lot you receive. Where a specification has to be met on
paper before shipment, it is agreed in writing and the lot is qualified against those limits rather
than against the catalogue text.

Release and retention

A lot is released only after the analytical work is complete and reviewed against the agreed
specification. A retained sample from every lot is kept for the stability window agreed with the
customer, so a question about a delivery can be answered with material rather than with a record.

Change notification

If a route, a supplier or an analytical method changes in a way that could move the impurity
profile, the change is notified before the next lot ships rather than after. This is the part of a
supply relationship that is easiest to skip and most expensive to skip.

Safety data

The SDS is written to GHS format and travels with the shipment. Where a compound has not yet been
classified for transport, the classification is completed before the lot is packed – not at the
forwarder’s desk.

Catalogue

Start from the index

Every catalogue entry carries its CAS number, formula, molecular weight and standard packing.

Open the index →