CA2546894A1 - Reference standard for characterization of rosuvastatin - Google Patents

Reference standard for characterization of rosuvastatin Download PDF

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Publication number
CA2546894A1
CA2546894A1 CA002546894A CA2546894A CA2546894A1 CA 2546894 A1 CA2546894 A1 CA 2546894A1 CA 002546894 A CA002546894 A CA 002546894A CA 2546894 A CA2546894 A CA 2546894A CA 2546894 A1 CA2546894 A1 CA 2546894A1
Authority
CA
Canada
Prior art keywords
rosuvastatin
characterization
reference standard
standard
analysis
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.)
Granted
Application number
CA002546894A
Other languages
French (fr)
Other versions
CA2546894C (en
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
Individual
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=CA2546894(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2546894A1 publication Critical patent/CA2546894A1/en
Application granted granted Critical
Publication of CA2546894C publication Critical patent/CA2546894C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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

Abstract

Provided are rosuvastatin degradation products and their use as a reference standard (including reference marker) for analysis of rosuvastatin.
CA002546894A 2003-12-02 2004-12-02 Reference standard for characterization of rosuvastatin Expired - Fee Related CA2546894C (en)

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 (2)

Publication Number Publication Date
CA2546894A1 true CA2546894A1 (en) 2005-06-23
CA2546894C CA2546894C (en) 2009-09-08

Family

ID=34676616

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002546894A Expired - Fee Related CA2546894C (en) 2003-12-02 2004-12-02 Reference standard for characterization of rosuvastatin

Country Status (13)

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

Families Citing this family (15)

* Cited by examiner, † Cited by third party
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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
DE602004032465D1 (en) * 2003-12-02 2011-06-09 Teva Pharma REFERENCE STANDARD FOR THE 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
JP5330225B2 (en) * 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 Triol rosuvastatin
EP2189456A1 (en) * 2008-11-14 2010-05-26 LEK Pharmaceuticals d.d. New compounds prepared from omeprazole
CN102325755B (en) 2008-12-30 2015-07-01 艾科尔公司 Substituted 5,6-dihydro-6-phenylbenzo[f] isoquinolin-2-amine compounds
CN103454352B (en) * 2013-07-30 2015-07-15 广东先强药业有限公司 Method for determining content of rosuvastatin calcium and related substances thereof by employing HPLC (high performance liquid chromatography) method
CN103776939A (en) * 2014-02-11 2014-05-07 润泽制药(苏州)有限公司 Preparation detection method for substances related to rosuvastatin calcium preparation
CN108398501A (en) * 2018-03-02 2018-08-14 海南通用三洋药业有限公司 A method of the related substance of detection rosuvastain calcium
CN109020902B (en) * 2018-07-23 2020-06-02 唯智医药科技（北京）有限公司 Rosuvastatin calcium impurity, and preparation method and application thereof
CN114280181A (en) * 2021-12-23 2022-04-05 浙江海翔川南药业有限公司 Detection method of rosuvastatin intermediate and related substances thereof

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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 (en) * 1980-06-06 1986-07-28 Sankyo Co METHOD FOR PREPARING ML-236B CARBOXYLIC ACID DERIVATIVES
US4739073A (en) * 1983-11-04 1988-04-19 Sandoz Pharmaceuticals Corp. Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof
NO177005C (en) * 1988-01-20 1995-07-05 Bayer Ag Analogous process for the preparation of substituted pyridines, as well as intermediates for use in the preparation
US5177080A (en) * 1990-12-14 1993-01-05 Bayer Aktiengesellschaft Substituted pyridyl-dihydroxy-heptenoic acid and its salts
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JP2648897B2 (en) * 1991-07-01 1997-09-03 塩野義製薬株式会社 Pyrimidine derivatives
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GB9812413D0 (en) * 1998-06-10 1998-08-05 Glaxo Group Ltd Compound and its use
SI20070A (en) 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. NOVEL SALTS OF INHIBITORS OF HMG-CoA REDUCTASE
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
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KR100511533B1 (en) 2002-04-09 2005-08-31 임광민 CHIRAL INTERMEDIATE, PROCESS FOR THE PRODUCTION THEREOF, AND PROCESS FOR THE PRODUCTION OF HMG-CoA REDUCTASE INHIBITOR
AU2003228010A1 (en) * 2002-05-21 2003-12-02 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
HUP0500851A3 (en) 2002-12-10 2008-02-28 Ranbaxy Lab Ltd Process for the preparation of rosuvastatin
WO2005021511A1 (en) 2003-08-27 2005-03-10 Hetero Drugs Limited A novel process for amorphous rosuvastatin calcium
WO2005040134A1 (en) * 2003-10-22 2005-05-06 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium
EP1601658A1 (en) * 2003-11-24 2005-12-07 Teva Pharmaceutical Industries Limited Crystalline ammonium salts of rosuvastatin
DE602004032465D1 (en) * 2003-12-02 2011-06-09 Teva Pharma REFERENCE STANDARD FOR THE 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
CA2594692A1 (en) 2005-01-31 2006-08-03 Ciba Specialty Chemicals Holding Inc. Crystalline forms of rosuvastatin calcium salt
EP1863773A1 (en) 2005-03-22 2007-12-12 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
WO2006136407A1 (en) 2005-06-24 2006-12-28 Lek Pharmaceuticals D.D. Process for preparing amorphous rosuvastatin calcium free of impurities
EP1915349B2 (en) 2005-06-24 2018-09-12 LEK Pharmaceuticals d.d. Process for preparing pure amorphous rosuvastatin calcium
GB0514078D0 (en) 2005-07-08 2005-08-17 Astrazeneca Uk Ltd Chemical process

Also Published As

Publication number Publication date
US20090188305A1 (en) 2009-07-30
KR100887264B1 (en) 2009-03-06
CA2546894C (en) 2009-09-08
US20070249830A1 (en) 2007-10-25
CN1894221A (en) 2007-01-10
JP2007512354A (en) 2007-05-17
IL175511A0 (en) 2006-09-05
US20070255059A1 (en) 2007-11-01
ES2364143T3 (en) 2011-08-25
US7741482B2 (en) 2010-06-22
US20070244321A1 (en) 2007-10-18
US20050187234A1 (en) 2005-08-25
EP1689723B1 (en) 2011-04-27
IL175511A (en) 2011-11-30
TW200522959A (en) 2005-07-16
JP4733047B2 (en) 2011-07-27
US7244844B2 (en) 2007-07-17
KR20060098396A (en) 2006-09-18
PT1689723E (en) 2011-07-06
EP1689723A1 (en) 2006-08-16
US8487097B2 (en) 2013-07-16
ATE507209T1 (en) 2011-05-15
CN1894221B (en) 2012-08-08
US7692010B2 (en) 2010-04-06
WO2005056534A1 (en) 2005-06-23
DE602004032465D1 (en) 2011-06-09
US20070249831A1 (en) 2007-10-25
TWI351958B (en) 2011-11-11
US7692008B2 (en) 2010-04-06
US7692009B2 (en) 2010-04-06

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Effective date: 20201202

MKLA Lapsed

Effective date: 20201202