Sodium Chloride → Formoterol

HRID 1983202

반응식

HRID 1983202 반응식
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

참가 물질

6

반응물 4

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

생성물 1

HCID 3410Formoterol

시약·촉매·용매 1

HCID 962Water용매2회

실험 절차

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.

후처리

  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

출처 및 근거

ORD 기록
ord-aacb7600d598450ea707b8ccec57dace
출처 데이터셋
uspto-grants-2009_06
특허 번호
US07541385B2

연결된 노트

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