Phosphoric Acid → Pamidronate Disodium Anhydrous

HRID 1007628

Reaktionsgleichung

Reaktionsgleichung von HRID 1007628
C(O)[C@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O.[CH2:13]([C:16]([P:22]([OH:25])([OH:24])=[O:23])([P:18]([OH:21])([OH:20])=[O:19])[OH:17])[CH2:14][NH2:15].[OH-].[Na+:27].P(=O)(O)(O)O>O>[CH2:13]([C:16]([P:22]([O-:25])([OH:24])=[O:23])([P:18]([O-:20])([OH:21])=[O:19])[OH:17])[CH2:14][NH2:15].[Na+:27].[Na+:27]

Komponenten

6

Edukt 4

HCID 1004Phosphoric AcidHCID 4674Pamidronic AcidHCID 6251Mannitol3×HCID 14798Sodium Hydroxide2×

Produkt 1

HCID 73351Pamidronate Disodium Anhydrous

Reagenzien, Katalysatoren, Lösungsmittel 1

HCID 962WaterLösungsmittel

Versuchsvorschrift

For a batch size of 5 L, 587.5 g (3.2 moles) of mannitol is dissolved in 3.5 L of water. Pamidronic acid (31.6 g, 0.133 moles) is mixed with a 1.0 L aliquot of the mannitol solution to form a slurry. The slurry is transferred into the remainder of the mannitol solution, and stirred for about 15 min. Aqueous 1 N sodium hydroxide (270 ml) is added and the mixture is stirred until a clear, colorless solution results. The pH is adjusted to 6.5±0.1 using either 1 M aqueous phosphoric acid or 1 N aqueous sodium hydroxide, as needed. The solution is filtered through a 0.22 micron filter, and filled at 20° C. into glass vials at 4.0 ml (4.172 g)/vial, and the vials are sealed in the lyophilizer in an inert atmosphere under sterile conditions.

Aufarbeitung

  1. customto form a slurry
  2. stirringthe mixture is stirred until a clear, colorless solution
  3. customresults
  4. filtrationThe solution is filtered through a 0.22 micron
  5. filtrationfilter
  6. additionfilled at 20° C. into glass vials at 4.0 ml (4.172 g)/vial
  7. customthe vials are sealed in the lyophilizer in an inert atmosphere under sterile conditions

Quellen und Nachweise

ORD-Eintrag
ord-b5f7dfbb0d2e490f9da91b0a62f3fba1
Quelldatensatz
uspto-grants-2004_09
Patentnummer
US06794536B1

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