 |
|
|
 |
 |
|
Because your needs can change quickly, we maintain a fully stocked inventory
of chiral columns and
CSPs, all ready to be
shipped within 24
hours of your order. |
| more |
|
|
|
|
|
|
 |
|
 |
 |
|
|
|
|
| The Custom Separation Services of CHIRAL TECHNOLOGIES has been in operation for many years and is well established and well known. Following our move to new facilities in
West Chester, the service has expanded greatly with the addition of larger HPLC, SFC, and SMB preparative scale chromatographs. |
| Complete confidentiality |
| The process starts with the establishment of a confidentiality agreement to allow sharing of information while preserving the intellectual property of our customer and that of CHIRAL TECHNOLOGIES and Daicel. For many of our customers, this is already in place. We start a project by gathering information about the product,
its properties (structure, solubility, safety, what separations have already been tried) and about the needs (quantity, time scale, final product specification). |
| Product screening |
| Starting with a small quantity of racemate (~200 mg) we carry out a free screening on the product for separation using the preparative scale CSPs available to us. These comprise not only the commercially available materials but also several CSPs that have never been commercialized but which have proven to be very useful in
preparative separations. The screen, carried out using both HPLC and SFC, usually results in a promising separation which is then optimized to give the best preparative separation method. Because we screen over both SFC and HPLC we can propose the most economic process for the subsequent purification without being tied to one
process or the other. |
| Loading study |
| Once the separation is optimized, we carry out a loading study to determine the production rate possible for the range of techniques available, and to isolate a small quantity of one or both enantiomers for stability testing. This is a vital step in the procedure as it prevents a needless waste of effort to separate enantiomers
which will racemize under the recovery conditions. |
| With all the information in hand, we then prepare a quotation for the quantity of product required. Once this is approved and the order is placed, we commence the project, returning the purified enantiomers within the agreed time frame. |
| Analysis completion |
| After your separation is completed, the enantiomers are analyzed by our QC group to determine their enantiomeric and achiral purity, the assay for the sample, and residual solvent content. |
| The final products are returned to you accompanied by a Certificate of Analysis. For all cGMP projects, CHIRAL TECHNOLOGIES adheres to the ICH Q7, paragraph 19 guidelines. |
|
|
|
|
|
|
|
|
|
|
|
