All of our products are analyzed for identification and purity. This usually means obtaining an 1H NMR spectra and GC chromatogram and comparing them to the reference data for the product. Occasionally, we'll also take an LC-MS, 13C NMR, or FT-IR.
For products that we market as Scavengers or Reagents, we also check for non-fluorous impurities. This involves passing the product through a FluoroFlash F-SPE cartridge using our standard F-SPE conditions and analyzing the non-fluorous wash by 1H NMR with an internal standard for quantification purposes. The required standard is less than 1 mol percent non-fluorous impurities.
Once we're satisfied that we've made the right product, the batch is clearly labeled with the part number, structure, lot number and unique barcode. A Record of Analysis for the lot is created, listing the tests performed and the results of the test. All supporting data for the batch are attached to the Record of Analysis and are reviewed by a chemist not involved in the synthesis. The Record of Analysis is signed by both the issuing and reviewing chemists. Only when this is done is the material released for sale.
Copies of the Records of Analysis are always available to customers upon request.
The guiding philosphy during all this is that we have a process with some redundancies in place which will help ensure quality. Two analytical tests and two sets of eyes reviewing the data. In addition, by having the Records of Analysis available there is a built-in accountability should something go wrong.
When an order for an in-stock material is entered into our fulfillment system, the appropriate product bottle is pulled from our inventory and an order fulfillment checklist is followed. A chemist reviews the bottle and the purchase order to ensure that the proper material, name and product #, is being packaged and that the lot # and bottle barcode are recorded. The chemist also ensures that a Record of Analysis is on hand for that lot. The chemist informally checks the material to determine if it has degraded since it was last analyzed. This is typically a visual check, though it can involve additional instrumental analysis at the discretion of the reviewing chemist. If the ordered product is a chemical that we know can degrade, then we will re-analyze it prior to shipping. Once deemed ok, the reviewer initials our order fulfillment checklist.
A second person is involved in the bottling and packaging of the product. Their responsibilities include:
Once these duties are completed, the order fulfillment checklist is initialed and the bottle is boxed for pick-up. The order fulfillment checklist is then stored with a copy of the purchase order, so that if any problems arise we can quickly retrieve the order history and resolve problems quickly.
As in the case of producing the material itself, a key element of this process is to make sure that two people are involved in the order fulfillment thereby reducing the chances of an error occurring.
Despite our efforts and protocols, mistakes are occasionally made. We appreciate being contacted when reactions do not work as planned and are glad to help. We stand behind our products and will work to meet your high expectations for quality. Here are some of the things that we will do when you contact us about a problem with one of our products.
We'll first try to determine if we sent the correct product by checking the documentation created during production and order fulfillment. Did the purchase order list the desired product? Does the label on the bottle match the PO? Are the supporting documents correct? Did we send the correct quantity?
If you have obtained some analytical data then we'll compare it to our Record of Analysis (or provide you with the Record). We'll also re-analyze the lot if it's still in stock. We can also run a test reaction or FSPE to make sure that there's not some unidentified problem that our analytical techniques are missing.
Replacement material can be quickly sent if it's in stock, and the original problematic material can be returned to us at our cost if necessary. In general our response to customers is to assume that we made an error, to identify the error, and to correct that error. The next step, or course, is to try and put in place a process that will prevent that error from reoccurring.
If it seems like the problem is not related to any error on our part, but arose due to the chemistry involved, then we're more than willing to help improve on your fluorous approach. We're happy to enter into a confidentiality agreement if that makes it easier for you to disclose the exact nature of the problem.