Abstract: Processes for preparing and purifying Pregabalin and salts thereof are provided.

Abstract: Processes are provided for preparing mupirocin calcium dihydrate from pseudomonic acid in a two phase system by using an organic carboxylate. A highly pure composition of amorphous mupirocin calcium is provided, and processes for its preparation by solvent removal, lyophilization and precipitation with use of an anti-solvent. Pharmaceutical compositions of amorphous form, and methods of using them to treat infections are also provided. Also provided are combined processes for preparing mupirocin calcium dihydrate and amorphous, by producing amorphous form first, followed by conversion of amorphous form into the dihydrate through crystallization from an aqueous solution. Also provided are processes for removing the water of crystallization of the dihydrate to obtain mupirocin calcium anhydrate.

Abstract: The present invention provides a stable 2-(2-pyridylmethyl) sulfinyl-1H-benzimidazole (lansoprazole) comprising either greater than 500 ppm and not more than about 3,000 ppm water or greater than 200 ppm and not more than about 5,000 ppm alcohol, or both. The present invention provides a method of preparing a stable lansoprozole as well as a pharmaceutical composition containing same. The present invention further provides a method of purifying lansoprazole that is substantially free of sulfone and sulfide derivatives.

Abstract: 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.

Abstract: The present invention provides a stable 2-(2-pyridylmethyl)sulfinyl-1H-benzimidazole (lansoprazole) and a method for stabilizing lansoprazole by use of a weakly basic material. The present invention also provides a method for the preparation of a stable lansoprazole.

Abstract: The invention relates to pure (R)-CMH and to the optical resolution of CMH-racemate, a key intermediate in the synthesis of (S)-Pregabalin. The invention also relates to the process for optically purifying (R)-CMH and to the process for isolating (S)-CMH from the mother liquor.

Abstract: 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.

Abstract: The invention relates to pure (R)—CMH and to the optical resolution of CMH-racemate, a key intermediate in the synthesis of (S)-Pregabalin. The invention also relates to the process for optically purifying (R)—CMH and to the process for isolating (S)—CMH from the mother liquor.

Abstract: Provided are processes for the preparation of clopidogrel bisulphate Form I.

Abstract: Provided is a process for preparation of amorphous form of an active pharmaceutical ingredient.

Abstract: The present invention encompasses processes for the preparation and purification of paliperidone palmitate.

Abstract: Processes for the preparation of dorzolamide hydrochloride and an intermediate of Formula IV, are provided.

Abstract: Provided are amorphous and crystalline forms of ibandronate disodium, as well as processes for the preparation thereof.

Abstract: A crystalline ibandronic acid characterized by data selected from the group consisting of at least one of a powder x-ray diffraction pattern having peaks at about 4.1, 12.3 and 13.4±0.2 degrees two-theta and at least two more peaks selected from the group consisting of: 8.2, 11.3, 16.2 and 16.9 and 20.8±0.2 degrees two-theta, and by a powder X-ray diffraction pattern depicted in FIG. 1 is provided. Also provided is a crystalline ibandronic acid characterized by data selected from the group consisting of at least one of a powder x-ray diffraction pattern having peaks at about peaks at about 5.2, 11.7, and 18.7±0.2 degrees two-theta and at least two more peaks selected from the group consisting of: 5.8, 10.1, 12.0, 17.1, and 20.0±0.2 degrees two-theta and a powder X-ray diffraction pattern as depicted in FIG. 2. Methods of preparing the crystalline forms are also provided.

Abstract: Provided are crystalline forms of ibandronate sodium, as well as processes for the preparation thereof.

Abstract: The present invention encompasses Pregabalin substantially free of Lactam and a process for obtaining Pregabalin substantially free of Lactam comprising extracting an acidic mixture containing a complex of Pregabalin with a strong mineral acid, with C3-8 alcohol; and combining the organic phase with an organic base.

Abstract: Provided are crystalline forms of ibandronate sodium, as well as processes for the preparation thereof.

Abstract: A Pregabalin having a low level of 3-isobutylglutaric acid is provided.

Abstract: The invention relates to the ? polymorph of Aztreonam, which contains less than 2.5% by weight residual solvent and to a process of making said polymorph. In the process of the invention, a polymorph of Aztreonam is dissolved in an absolute C1-6 alcohol in the presence of a base to form a solution, an acid is added to the solution, and the solution is stirred efficiently.

Abstract: Provided are processes for the preparation of mycophenolate mofetil and other esters of mycophenolic acid.