Process for manufacture of in vivo stain composition

a technology of in vivo stain composition and manufacturing process, which is applied in the direction of drug compositions, applications, instruments, etc., can solve the problems of reducing yield, reducing product purity, and reducing yield

Inactive Publication Date: 2001-07-12
DEN MAT HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If too little water is used (1) all of the TBO does not get dissolved, reducing the yield and (2) it decreases the purity of the product.
.sup.2 If too little sodium chloride is used, all of the product will not be salted out, reducing yield.
If too much sodium chloride is used it will cause impurities to precipitate out along with the TBO, decreasing the purity of the product.

Method used

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  • Process for manufacture of in vivo stain composition
  • Process for manufacture of in vivo stain composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

Manufacturing Process

[0031] This example illustrates, in the detail required to satisfy regulatory required GMP conditions, the exact procedures for carrying out the commercial scale manufacture of a batch of TBO dye product, according to the process which embodies the presently known best mode of the invention.

Preparation of Raw Materials Solutions

[0032] Equipment / supplies:

[0033] A. Ohaus IP15KS Balance

[0034] B. AnD HV150KAI Balance

[0035] C. Fairbanks H90-5150 Balance

[0036] D. OHAUS WB25 / 1-20W Balance

[0037] E. Cole Parmer (51201-30) and Thermolyne (S25535)Stirrers

[0038] F. Sampling devices, such as steel scoops, drum samplers, etc.

[0039] G. Erlyenmeyer flasks, beakers, carboys and other appropriate glassware.

[0040] H. Production Solution Labels.

[0041] Safety:

[0042] Protective equipment, such as gloves, safety glasses, lab coats, and respirators should be worn when handling chemicals according to MSDS guidelines.

[0043] Raw Material Solutions Preparation Procedure:

[0044] To Hydrochlo...

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Abstract

A process for synthesizing 2-amino-5-dimethlyaminophenyl thiosulfonic acid comprises the step of oxidizing N,N'-dimethyl-rho-phenylene-diamine in the presence of a source of thiosulfate ions, while maintaining the temperature of the reaction mixture not higher than about 10° C. This compound is useful as an intermediate in the synthesis of toluidine blue O. A process for manufacturing toluidine blue O with improved yield, includes the step of preparing the intermediate 2-amino-5-diethylaminopropyl thiosulfonic acid according to the above described procedure.

Description

[0001] This application is a continuation of my co-pending U.S.A. application, Ser. No. 09 / 110,788, filed Jul. 6, 1998, which was, in turn, a continuation-in-part of International Application, PCT US / 97 / 20981, filed Nov. 13, 1997, entitled IN VIVO STAIN COMPOSITION, PROCESS OF MANUFACTURE, AND METHODS OF USE TO IDENTIFY DYSPLASTIC TISSUE.[0002] This invention pertains to improved methods of manufacturing TBO compositions, including the novel compositions which are disclosed in my above-identified prior applications.[0003] In another aspect, the invention concerns a method and process for manufacturing TBO compositions with improved yield, leading to manufacturing economies and increased productive capacity of the manufacturing equipment.[0004] The various embodiments of the invention and the practice thereof will be apparent to those skilled in the art, from the following detailed description thereof, taken in conjunction with the claims and in conjunction with the drawings, in whic...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B10/00C07D279/20G01N30/88C09B21/00C09B67/22G01N30/02
CPCA61K49/006C07D279/20C09B21/00G01N30/34G01N30/36G01N2030/027A61P35/00A61P43/00
Inventor BURKETT, DOUGLAS D.
Owner DEN MAT HLDG
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