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Preparation of form 1 ranitidine hydrochloride

Patent 5338871 Issued on August 16, 1994. Estimated Expiration Date: Icon_subject April 1, 2013. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.

Patent References

Nitrovinyl aziridine derivative
Patent #: 4460506
Issued on: 07/17/1984
Inventor: Bradshaw

Process for the recovery of S-(carboxymethyl)-(R)-cysteine and S-(carboxymethyl)-(S)-cysteine
Patent #: 4551548
Issued on: 11/05/1985
Inventor: Kleemann ,   et al.

Optical resolution process for DL-cysteine
Patent #: 4613688
Issued on: 09/23/1986
Inventor: Inoue ,   et al.

Furan derivatives useful for the treatment of gastro-intestinal disorders Patent #: 5075301
Issued on: 12/24/1991
Inventor: Sasho, et al.

Inventors

Assignee

Application

No. 041354 filed on 04/01/1993

US Classes:

549/492Nitrogen and the hetero ring are single bonded directly to the same acyclic saturated hydrocarbon group

Examiners

Primary: Ivy, C. Warren
Assistant: Owens, A. A.

Attorney, Agent or Firm

International Class

C07D 307/52

Abstract

Pure Form 1 ranitidine hydrochloride is prepared by a process of crystallization from a solution of ranitidine hydrochloride in a mixed solvent comprising 1 part by volume of at least one lower alkanol such as ethanol and 1-2.0 parts by volume of a C6 -C10 aromatic hydrocarbon such as toluene, and in the presence of seed crystals of pure Form 1 ranitidine hydrochloride. In the preferred process according to the invention, the ranitidine hydrochloride is prepared in situ in the solvent mixture by adding hydrochloric acid to a solution of the free base in the solvent mixture, in the presence of the seed crystals.

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