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1.发明申请公开(公告)号：US20200010578A1
公开(公告)日：2020-01-09
申请号：US16526336
申请日：2019-07-30
Applicant: Chemi S.P.A.
Inventor： Lorenzo De Ferra , Annamaria Naggi , Maurizio Zenoni , Barbara Pinto
Abstract: A method for the qualification and selection of manufacturing processes, raw materials, intermediates and batch production of pentosan polysulfate based on the identification of acetylated monosaccharide units, including units of xylose substituted with 4-O-methyl-glucuronic which also lead the acetyl group, as structural characterizing units, is disclosed.
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公开(公告)号：US09272982B2
公开(公告)日：2016-03-01
申请号：US14308828
申请日：2014-06-19
Applicant: CHEMI S.P.A.
Inventor： Umberto Ciambecchini , Elio Ullucci , Stefano Turchetta , Maurizio Zenoni
IPC: C07C227/16 , C07C59/40 , C07C219/28
CPC classification number: C07C227/16 , C07C59/40 , C07C219/28
Abstract: A process is described for preparing fesoterodine fumarate comprising the salification reaction of fesoterodine with fumaric acid in an organic solvent, preferably a ketone, at a temperature not greater than 45° C. Such process allows obtaining products with high yields and purities, and in particular a product having a content of (2E)-4-[(3-(3-diisopropylamino-1-phenylpropyl)-4-(2-isobutyroyloxyphenyl)methoxy]-4-oxobut-2-enoic acid less than or equal to 0.15% by mole.
Abstract translation: 描述了在不高于45℃的温度下，在有机溶剂（优选酮）中制备非索特罗定富马酸与富马酸的成盐反应的方法，该方法允许获得高产率和纯度的产物，特别是 具有（2E）-4 - [（3-（3-二异丙基氨基-1-苯基丙基）-4-（2-异丁酰氧基苯基）甲氧基] -4-氧代丁-2-烯酸含量小于或等于0.15的产物 ％摩尔。
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公开(公告)号：US11242412B2
公开(公告)日：2022-02-08
申请号：US16526336
申请日：2019-07-30
Applicant: Chemi S.P.A.
Inventor： Lorenzo De Ferra , Annamaria Naggi , Maurizio Zenoni , Barbara Pinto
Abstract: A method for the qualification and selection of manufacturing processes, raw materials, intermediates and batch production of pentosan polysulfate based on the identification of acetylated monosaccharide units, including units of xylose substituted with 4-O-methyl-glucuronic which also lead the acetyl group, as structural characterizing units, is disclosed.
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公开(公告)号：US10787469B2
公开(公告)日：2020-09-29
申请号：US16360052
申请日：2019-03-21
Applicant: Chemi S.P.A.
Inventor： Lorenzo De Ferra , Mauro Anibaldi , Maurizio Zenoni , Fabrizio Cocchi
Abstract: A process for the purification of L-α-glycerophosphorylcholine is described, wherein L-α-glycerophosphorylcholine is crystallized from DMSO or from a mixture of DMSO with at least another solvent, preferably selected from water, alcohol, halogenated solvents, ethers, esters and/or amides. Such a process allows to obtain L-α-glycerophosphorylcholine having a purity greater than 99.5%, preferably greater than 99.7%, even more preferably greater than or equal to 99.9%. A method for determining the purity of L-α-glycerophosphorylcholine is also described, comprising the elution of L-α-glycerophosphorylcholine through an HPLC column having an amino stationary phase, and subsequent detection of L-α-glycerophosphorylcholine itself, and any impurity thereof, by means of an Evaporative Light Scattering Detector type.
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公开(公告)号：US10539568B2
公开(公告)日：2020-01-21
申请号：US15351599
申请日：2016-11-15
Applicant: Chemi S.P.A.
Inventor： Maria Lattanzio , Aureliano Gaiassi , Andrea Stevenazzi
Abstract: The present invention relates to reversed phase high-performance liquid chromatography (HPLC) methods useful for the characterisation of glatiramer acetate or similar polypeptide mixtures. The method described herein can distinguish glatiramer acetate from non-conforming copolymers and may be used to choose batches of glatiramer acetate suitable for pharmaceutical use.
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Patent Agency Ranking
公开(公告)号：US20170146547A1
公开(公告)日：2017-05-25
申请号：US15351599
申请日：2016-11-15
Applicant: Chemi S.P.A.
Inventor： Maria Lattanzio , Aureliano Gaiassi , Andrea Stevenazzi
CPC classification number: G01N33/6803 , B01D15/325 , C07K1/20 , C07K14/001 , G01N30/74 , G01N30/88 , G01N33/68 , G01N33/94 , G01N2030/8831 , G01N2333/001
Abstract: The present invention relates to reversed phase high-performance liquid chromatography (HPLC) methods useful for the characterisation of glatiramer acetate or similar polypeptide mixtures. The method described herein can distinguish glatiramer acetate from non-conforming copolymers and may be used to choose batches of glatiramer acetate suitable for pharmaceutical use.
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公开(公告)号：US20170101425A1
公开(公告)日：2017-04-13
申请号：US15317441
申请日：2015-06-09
Applicant: Chemi S.P.A.
Inventor： Lorenzo De Ferra , Mauro Anibaldi , Maurizio Zenoni , Fabrizio Cocchi
CPC classification number: C07F9/103 , B01D15/08 , C07F9/091 , C07F9/106 , C07F9/65742 , G01N21/49 , G01N30/02 , G01N2030/027
Abstract: A process for the purification of L-α-glycerophosphorylcholine is described, wherein L-α-glycerophosphorylcholine is crystallized from DMSO or from a mixture of DMSO with at least another solvent, preferably selected from water, alcohol, halogenated solvents, ethers, esters and/or amides. Such a process allows to obtain L-α-glycerophosphorylcholine having a purity greater than 99.5%, preferably greater than 99.7%, even more preferably greater than or equal to 99.9%. A method for determining the purity of L-α-glycerophosphorylcholine is also described, comprising the elution of L-α-glycerophosphorylcholine through an HPLC column having an amino stationary phase, and subsequent detection of L-α-glycerophosphorylcholine itself, and any impurity thereof, by means of an Evaporative Light Scattering Detector type.
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公开(公告)号：US10407515B2
公开(公告)日：2019-09-10
申请号：US14762784
申请日：2014-01-23
Applicant: CHEMI S.P.A.
Inventor： Lorenzo De Ferra , Annamaria Naggi , Maurizio Zenoni , Barbara Pinto
Abstract: A method for the qualification and selection of manufacturing processes, raw materials, intermediates and batch production of pentosan polysulfate based on the identification of acetylated monosaccharide units, including units of xylose substituted with 4-O-methyl-glucuronic which also lead the acetyl group, as structural characterizing units, is disclosed.
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公开(公告)号：US20150232508A1
公开(公告)日：2015-08-20
申请号：US14419493
申请日：2013-08-01
Applicant: CHEMI S.P.A.
Inventor： Stefano Turchetta , Maurizio Zenoni , Umberto Ciambecchini , Paolo Brandi , Vincenzo De Sio , Giorgio Berardi
IPC: C07K5/065
CPC classification number: C07K5/06078 , C07F5/04
Abstract: Bortezomib esters with tartaric acid wherein the molar ratio between bortezomib and tartaric acid is 2:1 and formulations containing them are described.
Abstract translation: 描述了硼替佐米酯与酒石酸，其中硼替佐米与酒石酸之间的摩尔比为2:1，含有它们的制剂被描述。
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公开(公告)号：US20140378518A1
公开(公告)日：2014-12-25
申请号：US14306316
申请日：2014-06-17
Applicant: CHEMI S.P.A.
Inventor： Stefano Turchetta , Maurizio Zenoni , Paolo Brandi
IPC: A61K9/19 , A61K31/4184
CPC classification number: A61K9/19 , A61K9/0019 , A61K31/4184 , A61K47/26
Abstract: New formulations of bendamustine hydrochloride having HPLC purity higher than 99% obtained through the lyophilization of aqueous solutions without organic solvents, are described.
Abstract translation: 描述了通过没有有机溶剂的水溶液冻干获得的HPLC纯度高于99％的盐酸苯达莫司汀的新制剂。
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