Sodium Chloride → Formoterol

HRID 1394384

反応式

HRID 1394384 の反応式
O.C(O)(=O)CC(CC(O)=O)(C(O)=O)O.O.O.C([O-])(=O)CC(CC([O-])=O)(C([O-])=O)O.[Na+].[Na+].[Na+].[Cl-].[Na+].[CH3:35][CH:36]([NH:46][CH2:47][CH:48]([OH:59])[C:49]1[CH:50]=[CH:51][C:52]([OH:58])=[C:53]([NH:55][CH:56]=[O:57])[CH:54]=1)[CH2:37][C:38]1[CH:39]=[CH:40][C:41]([O:44][CH3:45])=[CH:42][CH:43]=1.C(/C(O)=O)=C\C(O)=O.O.O>O>[CH3:35][CH:36]([NH:46][CH2:47][CH:48]([OH:59])[C:49]1[CH:50]=[CH:51][C:52]([OH:58])=[C:53]([NH:55][CH:56]=[O:57])[CH:54]=1)[CH2:37][C:38]1[CH:39]=[CH:40][C:41]([O:44][CH3:45])=[CH:42][CH:43]=1

参加物

6

反応物 4

HCID 5234Sodium ChlorideHCID 222302-Hydroxy-1,2,3-propanetricarboxylic acid hydrate (1:1)HCID 71474Sodium Citrate DihydrateHCID 11954385HCID 11954385、化合物

生成物 1

HCID 3410Formoterol

試薬・触媒・溶媒 1

HCID 962Water溶媒2 回

実験手順

In a clean stainless steel (SS) tank fitted with bottom drain, 75% of the required amount of purified water is added. Samples are taken for pH, conductivity, and microbiological testing. Citric acid monohydrate, sodium citrate dihydrate and sodium chloride are added to the tank and mixed for 15 minutes to dissolve. A sample is taken at this point to check pH. Formoterol fumarate dihydrate is added at this point and mixed for about 75 minutes to dissolve all active raw material. Purified water is used to adjust to final volume. The formulation is mixed for an additional 30 minutes and samples for pH and assay are taken based on which the formulation is released for filling. The bulk solution is filled into low density polyethylene (LDPE) vials (2 mL fill) in a form-fill-seal (FFS) machine. The released drug product solution is transferred from the formulation tank through sanitary delivery lines into the FFS machine. The individual vials are overwrapped with a suitable foil laminate.

後処理

  1. additionis added
  2. additionmixed for 15 minutes
  3. dissolutionto dissolve
  4. additionmixed for about 75 minutes
  5. dissolutionto dissolve all active raw material
  6. additionThe formulation is mixed for an additional 30 minutes
  7. customa form-fill-seal (FFS) machine

出典と根拠

ORDレコード
ord-acc6ecdb57344a6c8ee0bc1d13250219
出典データセット
uspto-grants-2008_03
特許番号
US07348362B2

関連ノート

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