Teva Pharmaceutical Industries Limited

Nina Finkelstein

Claude Singer

Anita Liberman

Marioara Mendelovici

Gideon Pilarski

Tamar Nidam

Irena Veinberg

Judith Aronhime

Ramy Lidor-Hadas

Viviana Braude

Shlomit Wizel

Barnaba Krochmal

Jeffrey Sterling

David Lerner

Yaacov Herzig

Alex Veinberg

Ariel Mittelman

Gideon Pilarsky

Kobi Chen

Yuriy Raizi

Isaac Milman

Varda Gilad

Gad Gilad

Provided are rosuvastatin degradation products and their use as a reference standard (including reference marker) for analysis of rosuvastatin.

Reference standard for characterization of rosuvastatin

The invention relates to solid states of pharmaceutically acceptable compounds of aliskiren, and processes for preparation thereof. The invention further provides pharmaceutical formulations comprising the amorphous or crystalline forms of pharmaceutically acceptable compounds of aliskiren and processes thereof; and a method of inhibiting renin for treating hypertension.

Solid state forms of aliskiren compounds

Crystalline pantoprazole sodium Forms II, IV, V, VI, VIII, IX, X, XI, XII, XIII, XIV, XV, XVI, XVII, XVIII, XIX and XX; pantoprazole sodium solvates containing water, acetone, butanol, methylethylketone, dimethylcarbonate, propanol and 2-methylpropanol; and amorphous pantoprazole sodium are disclosed.

Solid states of pantoprazole sodium, processes for preparing them and processes for preparing known pantoprazole sodium hydrates

The present invention provides a process comprising admixing a thioether with about 1.05 to about 1.6 molar equivalents of an active chlorine-containing oxidant, preferably sodium hypochlorite, and about 2.5 to about 5.0 molar equivalents of an alkali metal base; and recovering a sulfoxide that is preferably pantoprazole, lansoprazole, omeprazole, or rabeprazole. The process may further comprise contacting the sulfoxide with a source of sodium ions, preferably sodium hydroxide, to produce the sodium salt of the sulfoxide. The invention also relates to novel chlorinated derivatives of pantoprazole including 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)-chloromethyl]sulfinyl]-1H-benzimidazole and 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)-chlorohydroxymethyl]sulfinyl]-1H-benzimidazole and processes for making them. The invention also relates to processes of quantifying and identifying a compound other than pantoprazole in a mixture of pantoprazole and at least one other compound.

Process for preparing 2-[(pyridinyl)methyl]sulfinyl-substituted benzimidazoles and novel chlorinated derivatives of pantoprazole

The preparation of atorvastatin calcium epoxide dihydroxy (AED) is described. AED can be used as a standard or marker in determining the amount of AED in a sample. AED can therefore be used as a tool in preparing atorvastatin calcium substantially free of AED.

Process for preparing forms of atorvastatin calcium substantially free of impurities

The present invention provides a method for preparing a substantially pure lansoprazole containing less than about 0.2% (wt/wt) impurities including sulfone/sulfide derivatives. The present invention also provides a process for recrystallizing lansoprazole to obtain a lansoprazole containing less than about 0.1% (wt/wt) water.

Method for the purification of lansoprazole

The present invention provides substantially pure cilostazol. The present invention also provides cilostazol particles that have reduced particle size.

Substantially pure cilostazol and processes for making same

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Herzliya, Israel

Nina Finkelstein