http://rdf.ncbi.nlm.nih.gov/pubchem/patent/NZ-630427-A

Outgoing Links

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filingDate 2014-03-14-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_c1bbb24f8d8eaa6a112bbf0b340f3ff9
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publicationDate 2017-06-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber NZ-630427-A
titleOfInvention Crystals of laquinimod sodium and improved process for the manufacture thereof
abstract The present application provides subject-matter related to a mixture of crystalline laquinimod sodium particles, wherein (i) 90% or more of the total amount by volume of the laquinimod sodium particles have a size of less than 40 μιη or (ii) 50% or more of the total amount by volume of the laquinimod sodium particles have a size of less than 15 μιη and wherein one or more of further requirements are fulfilled with regard to bulk density, tapped density and the amount of certain impurities. The present application also provides a pharmaceutical composition comprising an amount of laquinimod and at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE. The subject invention also provides processes for preparing BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, and compounds prepared by said processes. Further provided is a process for testing whether a sample of laquinimod contains an undesirable impurity. Further provided are processes for (a) preparing a validated pharmaceutical composition comprising laquinimod, (b) distributing a validated batch of a pharmaceutical composition comprising laquinimod, (c) validating a batch of a pharmaceutical product containing laquinimod and (d) preparing a packaged pharmaceutical composition comprising laquinimod, each comprising determining the amount of at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE in a sample or batch. The subject invention further provides use of BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE as a reference standard to detect trace amounts of the impurity in a pharmaceutical composition comprising laquinimod. Finally, the subject invention provides methods of determining the concentration of BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, 5-HLAQ, SPIRO-LAQ or 3 H-LAQ in a pharmaceutical composition comprising laquinimod.
priorityDate 2013-03-14-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

Incoming Links

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Total number of triples: 33.