Determination of particulate contaminants in particles and compositions
OwnerAditya Krishna, Greg Fahs +2inventors
InventorsAditya Krishna, Greg Fahs, Nicholas Larson, Gabriel Lind
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Abstract
Provided herein are methods of detecting particulate contaminants in particles or a composition comprising particles, wherein the particles comprise a therapeutic or diagnostic agent, and wherein the particulate contaminants do not comprise the therapeutic or diagnostic agent.
Claims33
A method of detecting particulate contaminants in particles or a composition comprising particles, wherein the particles comprise a therapeutic or diagnostic agent, and wherein the particulate contaminants do not comprise the therapeutic or diagnostic agent, the method comprising:
- a) mixing the particles or the composition comprising particles with a dissolution media under conditions in which the particles dissolve to produce a mixture comprising soluble therapeutic or diagnostic agent;
- b) adding at least one destructive reagent to the mixture comprising the soluble therapeutic or diagnostic agent to degrade the therapeutic or diagnostic agent;
- c) filtering the mixture through a filtration apparatus comprising a first membrane filter;
- and
- d) inspecting the surface of the first membrane filter for the presence of particulate contaminants.
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A method of detecting particulate contaminants in particles or a composition comprising particles, wherein the particles comprise a therapeutic or diagnostic agent, and wherein the particulate contaminants do not comprise the therapeutic or diagnostic agent, the method comprising:
- a) mixing the particles or the composition comprising particles with a dissolution media under conditions in which the particles dissolve to produce a mixture comprising soluble therapeutic or diagnostic agent;
- b) adding at least one enzyme to the mixture comprising the soluble therapeutic or diagnostic agent to digest the therapeutic or diagnostic agent;
- c) filtering the mixture through a filtration apparatus comprising a first membrane filter;
- and
- d) inspecting the surface of the first membrane filter for the presence of particulate contaminants.
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A method of dissolving particles comprising a therapeutic or diagnostic agent, comprising:
- a) adding a dissolution media to particles or a composition comprising particles suspended in a liquid;
- b) mixing the dissolution media with the particles or the composition, thereby dissolving the particles to produce a solution comprising soluble therapeutic or diagnostic agent,
- wherein the dissolution media comprises non-ionic surfactant.
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A method of preparing a destructive reagent, comprising
- a) mixing a denaturant with a liquid to produce a first solution comprising a denaturant, wherein the denaturant comprises urea;
- b) mixing a reductant with a liquid to produce a second solution comprising the reductant, wherein the reductant comprises tris(2-carboxyethyl) phosphine hydrochloride, beta-mercaptoethanol, dithiotheriol, or a combination thereof;
- c) filtering the first and second solutions using a filtration apparatus, thereby obtaining a destructive reagent.
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A method of preparing a destructive reagent, comprising
- a) mixing a first denaturant with a second denaturant to produce a first solution;
- b) adding a reductant to the first solution to produce a second solution comprising the reductant, wherein the reductant comprises tris(2-carboxyethyl) phosphine hydrochloride, beta-mercaptoethanol, dithiotheriol, or a combination thereof;
- c) filtering the second solution using a filtration apparatus, thereby obtaining a destructive reagent.
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Dependencies are inferred from the claim text.