- Preparation method of ranitidine hydrochloride with low NDMA content
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The invention relates to the technical field of ranitidine hydrochloride preparation, in particular to a preparation method of ranitidine hydrochloride with low NDMA content, which comprises the following steps: adding a ranitidine base into ethanol, and stirring until complete dissloving is achieved; cooling the solution to -5 to 5 DEG C; controlling the temperature, adding a hydrochloric acid aqueous solution, adjusting the pH value to 4.5-6.5, and uniformly stirring; adding a seed crystal, preserving heat, stirring and crystallizing for 3-5 hours; and filtering a crystal, washing, drainingand drying to obtain the off-white crystal solid ranitidine hydrochloride. The salifying method disclosed by the invention has the advantages that the steps are simple, the raw material hydrochloric acid aqueous solution is easy to obtain, the product character is good, and the impurity content of the final product NDMA (N-Nitrosodimethylamine) is low.
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Paragraph 0016-0019
(2020/12/15)
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- Preparation method of high-transmittance ranitidine hydrochloride
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The invention discloses a preparation method of high-transmittance ranitidine hydrochloride. The preparation method comprises the following steps: (1) preparing a raw material solution; (2) preparing ranitidine by virtue of reaction; (3) purifying the ranitidine; (4) preparing ranitidine hydrochloride; (5) purifying the ranitidine hydrochloride. According to the preparation method of the high-transmittance ranitidine hydrochloride, by reasonably improving the process, controlling the temperature, controlling the stirring rate and controlling a dropwise adding rate of crystal solvent absolute ethyl alcohol as well as controlling the vacuum reaction conditions, the yield and purity of the ranitidine hydrochloride are effectively increased, the implementation feasibility of the production process is high, the industrialized mass production is facilitated, the obtained product is high in transmittance and transmission stability, good in crystal form, good in mobility, excellent in comprehensive performance, and high in practical application and market development value.
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Paragraph 0014; 0015
(2017/12/27)
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- Preparation of acid addition salts of amine bases by solid phase-gas phase reactions
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A process for the preparation of an acid addition salt of an organic base comprising exposing the organic base in solid form to a gaseous acid, with the proviso that ziprasidone, its acid addition salts and intermediates thereof are excluded.
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Page/Page column 3
(2008/06/13)
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- ANHYDROUS TABLET OF RANITIDINE HYDROCHLORIDE WITH DOUBLE-LAYER COATING AND ITS COMPOSITION
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The invention concerns an anhydrous tablet containing anhydrous ranitidine hydrochloride, coated by a double-layer coating, its composition and the relevant process of preparation. The anhydrous tablet of the invention is characterized by the direct dry tabletting, without using water, of a mixture consisting of the active ingredient anhydrous ranitidine hydrochloride, in the crystalline form "allomorphous Form 1" having a particular purity and stability, and by a global amount of other excipients and adjuvant substances or inert vehicles less than the weight of the active ingredient. Moreover, the anhydrous tablet of the invention is characterized by a high percentage of disintegrating substance in the tabletting mixture and by a special two-layer coating.
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Page/Page column 7
(2008/06/13)
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- Aminoalkyl furan derivatives
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Compounds of the general formula I: STR1 and physiologically acceptable salts thereof and N-oxides and hydrates, in which R1 and R2 which may be the same or different represent hydrogen, lower alkyl, cycloalkyl, lower alkenyl, aralkyl or lower alkyl interrupted by an oxygen atom or a group STR2 in which R4 represents hydrogen or lower alkyl or R1 and R2 may, together with the nitrogen atom to which they are attached, form a heterocyclic ring which may contain other heteroatoms selected from O and STR3 R3 is hydrogen, lower alkyl, lower alkenyl or alkoxyalkyl; X is --CH2 --, O or S; Y represents = S, = O, = NR5 or = CHR6 ; Alk denotes a straight or branched alkylene chain of 1 to 6 carbon atoms; R5 is H, nitro, cyano, lower alkyl, aryl, alkylsulphonyl, or arylsulphonyl; R6 represents nitro, arylsulphonyl or alkylsulphonyl; M is an integer from 2 to 4; and N is 1 or 2; or when X = S, or --CH2 --, n is zero, 1 or 2. These compounds have H2 -antagonist activity. Intermediates in the production thereof are also provided.
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