JP4733047B2 - ロスバスタチンの特性評価のためのリファレンス・スタンダード - Google Patents

ロスバスタチンの特性評価のためのリファレンス・スタンダード Download PDF

Info

Publication number
JP4733047B2
JP4733047B2 JP2006541502A JP2006541502A JP4733047B2 JP 4733047 B2 JP4733047 B2 JP 4733047B2 JP 2006541502 A JP2006541502 A JP 2006541502A JP 2006541502 A JP2006541502 A JP 2006541502A JP 4733047 B2 JP4733047 B2 JP 4733047B2
Authority
JP
Japan
Prior art keywords
rosuvastatin
degradation product
lactone
product
calcium
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 - Fee Related
Application number
JP2006541502A
Other languages
English (en)
Japanese (ja)
Other versions
JP2007512354A5 (US07692009-20100406-C00002.png
JP2007512354A (ja
Inventor
フィンケルシュタイン，ニーナ
Original Assignee
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
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=JP4733047(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 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 filed Critical 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
Publication of JP2007512354A publication Critical patent/JP2007512354A/ja
Publication of JP2007512354A5 publication Critical patent/JP2007512354A5/ja
Application granted granted Critical
Publication of JP4733047B2 publication Critical patent/JP4733047B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
JP2006541502A 2003-12-02 2004-12-02 ロスバスタチンの特性評価のためのリファレンス・スタンダード Expired - Fee Related JP4733047B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US52644903P 2003-12-02 2003-12-02
US60/526,449 2003-12-02
PCT/US2004/040329 WO2005056534A1 (en) 2003-12-02 2004-12-02 Reference standard for characterization of rosuvastatin

Publications (3)

Publication Number Publication Date
JP2007512354A JP2007512354A (ja) 2007-05-17
JP2007512354A5 JP2007512354A5 (US07692009-20100406-C00002.png) 2009-10-08
JP4733047B2 true JP4733047B2 (ja) 2011-07-27

Family

ID=34676616

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2006541502A Expired - Fee Related JP4733047B2 (ja) 2003-12-02 2004-12-02 ロスバスタチンの特性評価のためのリファレンス・スタンダード

Country Status (13)

Country Link
US (6) US7244844B2 (US07692009-20100406-C00002.png)
EP (1) EP1689723B1 (US07692009-20100406-C00002.png)
JP (1) JP4733047B2 (US07692009-20100406-C00002.png)
KR (1) KR100887264B1 (US07692009-20100406-C00002.png)
CN (1) CN1894221B (US07692009-20100406-C00002.png)
AT (1) ATE507209T1 (US07692009-20100406-C00002.png)
CA (1) CA2546894C (US07692009-20100406-C00002.png)
DE (1) DE602004032465D1 (US07692009-20100406-C00002.png)
ES (1) ES2364143T3 (US07692009-20100406-C00002.png)
IL (1) IL175511A (US07692009-20100406-C00002.png)
PT (1) PT1689723E (US07692009-20100406-C00002.png)
TW (1) TWI351958B (US07692009-20100406-C00002.png)
WO (1) WO2005056534A1 (US07692009-20100406-C00002.png)

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
WO2005056534A1 (en) * 2003-12-02 2005-06-23 Teva Pharmaceutical Industries Ltd. Reference standard for characterization of rosuvastatin
US7851624B2 (en) 2003-12-24 2010-12-14 Teva Pharamaceutical Industries Ltd. Triol form of rosuvastatin and synthesis of rosuvastatin
CA2591439C (en) 2005-02-22 2013-03-26 Teva Pharmaceutical Industries Ltd. Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof
AU2006329006B2 (en) * 2005-12-20 2013-02-28 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-dihydroxyhept-6-enoic acid
EP2121631A2 (en) * 2007-03-13 2009-11-25 Teva Pharmaceutical Industries Ltd. Triol form of rosuvastatin
EP2189456A1 (en) * 2008-11-14 2010-05-26 LEK Pharmaceuticals d.d. New compounds prepared from omeprazole
JP5739820B2 (ja) 2008-12-30 2015-06-24 アークル インコーポレイテッド 置換５，６−ジヒドロ−６−フェニルベンゾ［ｆ］イソキノリン−２−アミン化合物
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
CN114280181A (zh) * 2021-12-23 2022-04-05 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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5260440A (en) * 1991-07-01 1993-11-09 Shionogi Seiyaku Kabushiki Kaisha Pyrimidine derivatives

Family Cites Families (34)

* 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
ES2110499T3 (es) 1991-06-19 1998-02-16 Shionogi & Co Intermediario opticamente activo y su produccion.
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
US6777552B2 (en) 2001-08-16 2004-08-17 Teva Pharmaceutical Industries, Ltd. Processes for preparing calcium salt forms of statins
GB0028429D0 (en) 2000-11-22 2001-01-10 Astrazeneca Ab Therapy
WO2003016317A1 (en) 2001-08-16 2003-02-27 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
BR0311195A (pt) 2002-05-21 2005-02-22 Ranbaxy Lab Ltd Processo de preparação de rosuvastatina
GB0218781D0 (en) * 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
WO2004052867A1 (en) 2002-12-10 2004-06-24 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
AU2003269478A1 (en) 2003-08-27 2005-03-16 Hetero Drugs Limited A novel process for amorphous rosuvastatin calcium
US20070191318A1 (en) * 2003-10-22 2007-08-16 Yatendra Kumar 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
WO2005056534A1 (en) * 2003-12-02 2005-06-23 Teva Pharmaceutical Industries Ltd. Reference standard for characterization of rosuvastatin
WO2006035277A2 (en) 2004-09-27 2006-04-06 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
US20090124803A1 (en) 2005-03-22 2009-05-14 Pandurang Balwant Deshpande Process for preparation of rosuvastatin
WO2006106526A1 (en) 2005-04-04 2006-10-12 Unichem Laboratories Limited Process for preparation of calcium salt of rosuvastatin
CA2611920C (en) 2005-06-24 2015-05-05 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium
EP1912952B1 (en) 2005-06-24 2014-10-15 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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5260440A (en) * 1991-07-01 1993-11-09 Shionogi Seiyaku Kabushiki Kaisha Pyrimidine derivatives

Also Published As

Publication number Publication date
ES2364143T3 (es) 2011-08-25
DE602004032465D1 (de) 2011-06-09
US20070249831A1 (en) 2007-10-25
US7692009B2 (en) 2010-04-06
US20070255059A1 (en) 2007-11-01
JP2007512354A (ja) 2007-05-17
US20050187234A1 (en) 2005-08-25
KR100887264B1 (ko) 2009-03-06
CA2546894A1 (en) 2005-06-23
US20090188305A1 (en) 2009-07-30
EP1689723B1 (en) 2011-04-27
CA2546894C (en) 2009-09-08
TWI351958B (en) 2011-11-11
US7244844B2 (en) 2007-07-17
IL175511A0 (en) 2006-09-05
ATE507209T1 (de) 2011-05-15
PT1689723E (pt) 2011-07-06
US20070249830A1 (en) 2007-10-25
US7692010B2 (en) 2010-04-06
CN1894221B (zh) 2012-08-08
US20070244321A1 (en) 2007-10-18
US7692008B2 (en) 2010-04-06
IL175511A (en) 2011-11-30
US7741482B2 (en) 2010-06-22
EP1689723A1 (en) 2006-08-16
KR20060098396A (ko) 2006-09-18
WO2005056534A1 (en) 2005-06-23
CN1894221A (zh) 2007-01-10
TW200522959A (en) 2005-07-16
US8487097B2 (en) 2013-07-16

Similar Documents

Publication Publication Date Title
US7692010B2 (en) Reference standard for characterization of rosuvastatin
JP4996786B2 (ja) 結晶質の化合物ビス［（ｅ）−７−［４−（４−フルオロフェニル）−６−イソプロピル−２−［メチル（メチルスルホニル）アミノ］ピリミジン−５−イル］（３ｒ，５ｓ）−３，５−ジヒドロキシ−６−ヘプテン酸］カルシウム塩
JPH02250870A (ja) コレステロール生合成抑制性化合物
JPH0641448B2 (ja) ３−デメチルメバロン酸誘導体
JP2007512357A (ja) 不純物を実質的に含まないアトルバスタチンカルシウムの形態を調製するための方法
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
WO2009090158A1 (en) Atorvastatin-aliskiren
EP2334667A1 (en) A process for preparation of rosuvastatin acetonide calcium
Schneider et al. Determination of the new monoamine oxidase inhibitor brofaromine and its major metabolite in biological material by gas chromatography with electron-capture detection
CN101631777A (zh) 罗苏伐他汀的三醇形式

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20070226

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20071002

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20080829

RD03 Notification of appointment of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7423

Effective date: 20080902

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20090821

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20091124

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20100224

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20100406

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20100705

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20100712

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20100812

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20101019

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110119

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110126

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110202

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20110322

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20110421

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20140428

Year of fee payment: 3

R150 Certificate of patent or registration of utility model

Ref document number: 4733047

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees