| 摘要 |
Methods of evaluating heparin preparations, e.g., for suitability for use as a drug or for use in making a drug, by determining the absence, presence or amount of a structural signature, wherein, e.g., the structural signature is indicative of the methods used to make the heparin preparation. |
| 主权项 |
1. A method of identifying if a process was used to make a heparin preparation, comprising:
performing a separation process on a sample of the heparin preparation determining if a structural signature of one or more of:wherein R═SO3− or H and Y═SO3− or Acetyl, is absent from, present in, or present in an amount in, the separated heparin sample, wherein the presence or amount of the structural signature in the separated heparin sample indicates that the heparin preparation was made by a treatment method that includes treatment with a base, and/or an oxidation process, followed by treatment with a sulfite, and the absence of the structural signature in the separated heparin sample indicates that the heparin preparation was not made by the treatment method; and
if the heparin preparation was made by the treatment method, performing a step, wherein the step is one or more of classifying, selecting, accepting, discarding, releasing, withholding, processing into a drug product, shipping, formulating, labeling, packaging, releasing into commerce, selling, and offering for sale the heparin preparation. |
