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1. (WO2019049038) PROCESS FOR THE CHARACTERIZATION OF GLATIRAMER ACETATE
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Pub. No.: WO/2019/049038 International Application No.: PCT/IB2018/056770
Publication Date: 14.03.2019 International Filing Date: 05.09.2018
IPC:
A61K 38/02 (2006.01) ,G01N 30/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
02
Peptides of undefined number of amino acids; Derivatives thereof
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
30
Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography
Applicants:
ALEMBIC PHARMACEUTICALS LIMITED [IN/IN]; Alembic Research Centre Alembic Pharmaceuticals Limited Alembic Road vadodara 390003, IN
Inventors:
SAMA, Navya; IN
DAS, Tumpa; IN
SURYAPETA, Srinivas; IN
MOGULLA, Deepak; IN
KUMAR, Sourabh; IN
GUPTA, Praveer; IN
Priority Data:
IN20172103175007.09.2017IN
Title (EN) PROCESS FOR THE CHARACTERIZATION OF GLATIRAMER ACETATE
(FR) PROCESSUS POUR LA CARACTÉRISATION D'ACÉTATE DE GLATIRAMÈRE
Abstract:
(EN) The present invention is directed to process for characterization of Glatiramer acetate. The present invention further relates to process for characterization of Glatiramer acetate using size exclusion chromatography coupled with ultra performance liquid chromatography (SEC- UPLC) and high resolution mass spectrometry (HRMS). The present invention further provides statistical methods for characterizing and classifying Glatiramer acetate.
(FR) La présente invention concerne un processus pour la caractérisation d'acétate de glatiramère. La présente invention concerne en outre un processus pour la caractérisation d'acétate de glatiramère faisant appel à une chromatographie d'exclusion stérique couplée à une chromatographie en phase liquide à haute pression (SEC-UPLC) et à une spectrométrie de masse à haute résolution (HRMS). La présente invention concerne en outre des procédés statistiques pour la caractérisation et la classification d'acétate de glatiramère.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)