CN111925415A — 一种维拉卡肽杂质的制备方法
Assigned to Hainan Zhonghe Pharmaceutical Co ltd · Expires 2020-11-13 · 6y expired
What this patent protects
本发明公开了5个维拉卡肽杂质的制备方法。5个杂质肽序结构分别为：杂质I：D‑Cys(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；杂质II：Ac‑D‑Cys(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑OH；杂质III：Ac‑D‑Cys(Cys(S＝O))‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；杂质IV：Ac‑D‑Cys(S＝O)(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；…
USPTO Abstract
本发明公开了5个维拉卡肽杂质的制备方法。5个杂质肽序结构分别为：杂质I：D‑Cys(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；杂质II：Ac‑D‑Cys(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑OH；杂质III：Ac‑D‑Cys(Cys(S＝O))‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；杂质IV：Ac‑D‑Cys(S＝O)(Cys)‑D‑Ala‑D‑Arg‑D‑Arg‑D‑Arg‑D‑Ala‑D‑Arg‑NH 2 ；杂质V： 采用本发明的制备方法可以获得高纯度的杂质样品，HPLC纯度均高于96.0％。本发明涉及的5个维拉卡肽杂质均为潜在降解杂质，为维拉卡肽原料药和维拉卡肽注射剂的质量研究提供可靠的杂质对照品，以确保产品质量。
Drugs covered by this patent
- Parsabiv (ETELCALCETIDE) · Kai Pharms Inc
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
Track this patent
Get a daily-checked alert when vulnerability score, expiry, classification, or assignee changes. Email, Slack, or Teams delivery. Pro: 50 watches, Free: 3.