TABLE OF CONTENTS | STAGE 3 PREPARATIVE HPLC | |||
|---|---|---|---|
| PI Number | Modification Number | Job Number | Product Code Number |
| PI 0048 | 1 | 14449 | DW-12-14449 |
| Signature | Date | |
|---|---|---|
| Quality Assurance | _____ | _____ |
| Development Manager | _____ | _____ |
| Senior Chemist | _____ | _____ |
| GMP Facilities Manager | _____ | _____ |
| Safety | _____ | _____ |
This sheet shall be used to summarize any deviations that took place during the process. The deviation shall include reference to the specific step/steps and the corresponding Deviation Reference Number.
| Note | All deviations must be agreed in advance by the GMP Facilities Manager before proceeding. |
Abbreviations used in this document are consistent with those recommended by the International Union of Pure and Applied Chemists (IUPAC) unless otherwise stated.
| Abbreviation | IUPAC nomenclature |
|---|---|
| TFA | Trifluoroacetic acid |
To achieve ?97% purity, with no single impurity >1.5%, except up to 10% dimer as determined by the reversed phase HPLC conditions set out in 1.06. The purification is to be achieved by Reversed Phase Preparative HPLC using a 110 mm DAC column packed with 10 ? m C8 100 to a length of approximately 25 cm. The product will be purified by gradient elution using the Guideline Purification Strategy attached.
| Material | RM SOP Number | Approved for Use (QC cleared, within expiry date) |
|---|---|---|
| TFA | RM 1041 | |
| Acetone | RM 1004 | |
| MeCN | RM 1006 | |
| C8 10 ?m 100 | RM 1056 | |
| RO water | N/A |
| Item | ES SOP... |
|---|
