Process for the Preparation of Abaloparatide
AssigneeMylan Laboratories Limited
InventorsAnanda Kuppanna, Sureshbabu Jayachandra, Anil Kumar Tripathi, Bulliraju Kamana, Chandrashekhar Shanigaram
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Abstract
A process for the preparation of Abaloparatide or pharmaceutically acceptable salts. Also described is pure Abaloparatide or pharmaceutically acceptable salts thereof obtained from the process for the preparation of Abaloparatide.
Claims12
A process for the preparation of Abaloparatide comprising the steps of:
- a) anchoring a first protected terminal amino acid to a resin,
- b) capping the resin obtained in step a),
- c) selectively deprotecting the amino group,
- d) coupling a carboxyl terminus of the next N-protected amino acid to the amine group in the presence of a coupling reagent,
- e) repeating steps c) and d) to form a thirty-four peptide sequence,
- f) cleaving the peptide with a cocktail mixture from the resin to isolate a straight chain of crude Abaloparatide, and
- g) purifying by reverse phase HPLC to isolate pure Abaloparatide.
Abaloparatide containing as impurities, less than 0.10% Des-Thr33-Abaloparatide, less than 0.20% (4-34)-Abaloparatide, less than 0.10% (3-34)-Abaloparatide, less than 0.10% Des-Val2-Abaloparatide and less than 0.10% Des-Ser3-Abaloparatide.
Dependencies are inferred from the claim text.