ES2364143T3 - Estandar de referencia para caracterización de rosuvastatina. - Google Patents

Estandar de referencia para caracterización de rosuvastatina. Download PDF

Info

Publication number
ES2364143T3
ES2364143T3 ES04812772T ES04812772T ES2364143T3 ES 2364143 T3 ES2364143 T3 ES 2364143T3 ES 04812772 T ES04812772 T ES 04812772T ES 04812772 T ES04812772 T ES 04812772T ES 2364143 T3 ES2364143 T3 ES 2364143T3
Authority
ES
Spain
Prior art keywords
rosuvastatin
degradation product
lactone
acetonitrile
product
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
ES04812772T
Other languages
English (en)
Spanish (es)
Inventor
Nina Finkelstein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34676616&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2364143(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Application granted granted Critical
Publication of ES2364143T3 publication Critical patent/ES2364143T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
    • C07D239/70—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings condensed with carbocyclic rings or ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
    • C07D239/70—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings condensed with carbocyclic rings or ring systems
    • C07D239/72—Quinazolines; Hydrogenated quinazolines
    • C07D239/78—Quinazolines; Hydrogenated quinazolines with hetero atoms directly attached in position 2

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
ES04812772T 2003-12-02 2004-12-02 Estandar de referencia para caracterización de rosuvastatina. Expired - Lifetime ES2364143T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52644903P 2003-12-02 2003-12-02
US526449P 2003-12-02

Publications (1)

Publication Number Publication Date
ES2364143T3 true ES2364143T3 (es) 2011-08-25

Family

ID=34676616

Family Applications (1)

Application Number Title Priority Date Filing Date
ES04812772T Expired - Lifetime ES2364143T3 (es) 2003-12-02 2004-12-02 Estandar de referencia para caracterización de rosuvastatina.

Country Status (13)

Country Link
US (6) US7244844B2 (https=)
EP (1) EP1689723B1 (https=)
JP (1) JP4733047B2 (https=)
KR (1) KR100887264B1 (https=)
CN (1) CN1894221B (https=)
AT (1) ATE507209T1 (https=)
CA (1) CA2546894C (https=)
DE (1) DE602004032465D1 (https=)
ES (1) ES2364143T3 (https=)
IL (1) IL175511A (https=)
PT (1) PT1689723E (https=)
TW (1) TWI351958B (https=)
WO (1) WO2005056534A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
GB0324791D0 (en) 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
CN1894221B (zh) * 2003-12-02 2012-08-08 特瓦制药工业有限公司 用于表征罗苏伐他汀的参照标准品
US7851624B2 (en) 2003-12-24 2010-12-14 Teva Pharamaceutical Industries Ltd. Triol form of rosuvastatin and synthesis of rosuvastatin
US7612203B2 (en) * 2005-02-22 2009-11-03 Teva Pharmaceutical Industries Ltd. Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof
WO2007071357A2 (en) * 2005-12-20 2007-06-28 Lek Pharmaceuticals D.D. Pharmaceutical composition comprising (e) -7- [4- (4-fluorophenyl) -6-isopropyl-2- [methyl (methylsulfonyl) amino] pyrimidin-5 -yl- (3r, 5s) -3, 5-dihydr0xyhept-6-en0ic acid
JP5330225B2 (ja) * 2007-03-13 2013-10-30 テバ ファーマシューティカル インダストリーズ リミティド トリオール型ロスバスタチン
EP2189456A1 (en) * 2008-11-14 2010-05-26 LEK Pharmaceuticals d.d. New compounds prepared from omeprazole
TWI461410B (zh) 2008-12-30 2014-11-21 Arqule Inc 經取代之５，６－二氫－６－苯基苯並〔f〕異喹啉－２－胺化合物類
CN103454352B (zh) * 2013-07-30 2015-07-15 广东先强药业有限公司 一种hplc法测定瑞舒伐他汀钙的含量及其有关物质的方法
CN103776939A (zh) * 2014-02-11 2014-05-07 润泽制药(苏州)有限公司 瑞舒伐他汀钙制剂有关物质的制备检测方法
CN108398501A (zh) * 2018-03-02 2018-08-14 海南通用三洋药业有限公司 一种检测瑞舒伐他汀钙有关物质的方法
CN109020902B (zh) * 2018-07-23 2020-06-02 唯智医药科技（北京）有限公司 一种瑞舒伐他汀钙杂质及其制备方法与用途
CN114280181B (zh) * 2021-12-23 2024-06-18 浙江海翔川南药业有限公司 一种瑞舒伐他汀中间体及其有关物质的检测方法

Family Cites Families (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US37314A (en) * 1863-01-06 Improved composition for lemonade
US633198A (en) * 1899-02-08 1899-09-19 Wilhelm Magnus Hoekerstedt Automatic-lighting torch.
US4231938A (en) 1979-06-15 1980-11-04 Merck & Co., Inc. Hypocholesteremic fermentation products and process of preparation
US4444784A (en) 1980-08-05 1984-04-24 Merck & Co., Inc. Antihypercholesterolemic compounds
DK149080C (da) 1980-06-06 1986-07-28 Sankyo Co Fremgangsmaade til fremstilling af derivater af ml-236b-carboxylsyre
US4739073A (en) 1983-11-04 1988-04-19 Sandoz Pharmaceuticals Corp. Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof
NO177005C (no) 1988-01-20 1995-07-05 Bayer Ag Analogifremgangsmåte for fremstilling av substituerte pyridiner, samt mellomprodukter til bruk ved fremstillingen
US5177080A (en) 1990-12-14 1993-01-05 Bayer Aktiengesellschaft Substituted pyridyl-dihydroxy-heptenoic acid and its salts
JP3233403B2 (ja) 1991-06-19 2001-11-26 塩野義製薬株式会社 光学活性な中間体および該製造法
JP2648897B2 (ja) 1991-07-01 1997-09-03 塩野義製薬株式会社 ピリミジン誘導体
GB9626746D0 (en) 1996-12-23 1997-02-12 Knoll Ag Process
GB9812413D0 (en) 1998-06-10 1998-08-05 Glaxo Group Ltd Compound and its use
SI20070A (sl) 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Nove soli inhibitorjev HMG-CoA reduktaze
GB9903472D0 (en) 1999-02-17 1999-04-07 Zeneca Ltd Chemical process
GB0001621D0 (en) 2000-01-26 2000-03-15 Astrazeneca Ab Pharmaceutical compositions
GB0003305D0 (en) 2000-02-15 2000-04-05 Zeneca Ltd Pyrimidine derivatives
GB0028429D0 (en) 2000-11-22 2001-01-10 Astrazeneca Ab Therapy
KR20040026705A (ko) 2001-08-16 2004-03-31 테바 파마슈티컬 인더스트리즈 리미티드 스타틴의 칼슘 염 형태의 제조 방법
AU2002324715B2 (en) * 2001-08-16 2009-03-12 Teva Pharmaceutical Industries Ltd. Processes for preparing calcium salt forms of statins
SE0103509D0 (sv) 2001-10-19 2001-10-19 Astrazeneca Ab Rosuvastatin in pre demented states
KR100511533B1 (ko) 2002-04-09 2005-08-31 임광민 키랄 중간체, 그의 제조방법 및 그를 이용한 HMG-CoA환원저해제의 제조방법
EA200401533A1 (ru) 2002-05-21 2005-06-30 Ранбакси Лабораторис Лимитед Способ получения росувастатина
GB0218781D0 (en) * 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
DK1578733T3 (da) 2002-12-10 2011-06-14 Ranbaxy Lab Ltd Fremgangsmåde til fremstilling af rosuvastatin
WO2005021511A1 (en) 2003-08-27 2005-03-10 Hetero Drugs Limited A novel process for amorphous rosuvastatin calcium
EP1678148A1 (en) 2003-10-22 2006-07-12 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium
CA2546701C (en) 2003-11-24 2010-07-27 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
CN1894221B (zh) * 2003-12-02 2012-08-08 特瓦制药工业有限公司 用于表征罗苏伐他汀的参照标准品
EP1797046A2 (en) 2004-09-27 2007-06-20 Ranbaxy Laboratories Limited Novel processes for preparing amorphous rosuvastatin calcium and a novel polymorphic form of rosuvastatin sodium
WO2006079611A1 (en) 2005-01-31 2006-08-03 Ciba Specialty Chemicals Holding Inc. Crystalline forms of rosuvastatin calcium salt
WO2006100689A1 (en) 2005-03-22 2006-09-28 Unichem Laboratories Limited Process for preparation of rosuvastatin
WO2006106526A1 (en) 2005-04-04 2006-10-12 Unichem Laboratories Limited Process for preparation of calcium salt of rosuvastatin
WO2006136408A2 (en) 2005-06-24 2006-12-28 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium
CA2612587C (en) 2005-06-24 2013-02-19 Lek Pharmaceuticals D.D. Process for preparing amorphous rosuvastatin calcium free of impurities
GB0514078D0 (en) 2005-07-08 2005-08-17 Astrazeneca Uk Ltd Chemical process

Also Published As

Publication number Publication date
US20070255059A1 (en) 2007-11-01
ATE507209T1 (de) 2011-05-15
CA2546894A1 (en) 2005-06-23
IL175511A0 (en) 2006-09-05
US7692008B2 (en) 2010-04-06
US7692010B2 (en) 2010-04-06
JP4733047B2 (ja) 2011-07-27
EP1689723A1 (en) 2006-08-16
EP1689723B1 (en) 2011-04-27
US8487097B2 (en) 2013-07-16
US20090188305A1 (en) 2009-07-30
JP2007512354A (ja) 2007-05-17
US20070244321A1 (en) 2007-10-18
CA2546894C (en) 2009-09-08
US20070249831A1 (en) 2007-10-25
US7692009B2 (en) 2010-04-06
WO2005056534A1 (en) 2005-06-23
US7244844B2 (en) 2007-07-17
US20070249830A1 (en) 2007-10-25
US7741482B2 (en) 2010-06-22
TW200522959A (en) 2005-07-16
PT1689723E (pt) 2011-07-06
DE602004032465D1 (de) 2011-06-09
KR20060098396A (ko) 2006-09-18
IL175511A (en) 2011-11-30
US20050187234A1 (en) 2005-08-25
CN1894221B (zh) 2012-08-08
CN1894221A (zh) 2007-01-10
KR100887264B1 (ko) 2009-03-06
TWI351958B (en) 2011-11-11

Similar Documents

Publication Publication Date Title
US7692010B2 (en) Reference standard for characterization of rosuvastatin
CA2450820C (en) Processes for preparing calcium salt forms of statins
KR20010101390A (ko) 결정질 비스[(ｅ)-7-[4-(4-플루오로페닐)-6-이소프로필-2-[메틸(메틸설포닐)아미노]피리미딘-5-일](3ｒ,5ｓ)-3,5-디히드록시헵트-6-엔산]칼슘염
AU2002324715A1 (en) Processes for preparing calcium salt forms of statins
KR20030059253A (ko) 수산화 칼슘을 이용한[Ｒ(Ｒ*,Ｒ*)]-2-(4-플루오로페닐)-β,δ-디하이드록시-5-(1-메틸에틸)-3-페닐-4-[(페닐아미노)카보닐]-1Ｈ-피롤-1-헵탄산 에스테르의 가수분해
WO2007099561A1 (en) Process for preparing rosuvastatin calcium
CN101591301B (zh) 一种3,5-二羟基庚-6-烯酸衍生物的制备方法
JP5330225B2 (ja) トリオール型ロスバスタチン
US7884226B2 (en) Purification of rosuvatatin intermediate by thin film evaporation and chemical method
KR20140017207A (ko) 로수바스타틴 이소프로필 아민염, 이의 제조 방법 및 이를 이용한 로수바스타틴 헤미칼슘염의 제조방법
CA2579997A1 (en) Process for preparing forms of atorvastatin calcium substantially free of impurities
KR20050111629A (ko) 무정형 심바스타틴 칼슘 및 그의 제조방법
CN101631777A (zh) 罗苏伐他汀的三醇形式
WO2008008442A1 (en) Preparation and utility of hmg-coa reductase inhibitors
JP2007119473A (ja) （３ｒ，５ｒ）−７−［４−ベンジルカルバモイル−２−（４−フルオロフェニル）−５−イソプロピル−イミダゾール−１−イル］−３，５−ジヒドロキシ−ヘプタン酸ナトリウムの結晶形態