API specifications should be in line with a pharmacopoeial monograph (Ph. Int., European/British Pharmacopoeia (Eur./BP), Japanese Pharmacopoeia (JP) or USP) with additional tests/limits for arsenic; lead, alkalies and alkaline earths and iron if not included in that monograph. Such additional tests may be based on another pharmacopoeial monograph (Ph.Int., Ph.Eur./BP, JP, or USP).
