A worst case rating study, will priorities existing drug substances in a cleaning validation

program, based on information on applicable criteria:

(a) Hard to clean (on the basis of solubility of API & complex design of equipment)
(b) Solubility in solvent (i.e. water)
(c) Toxicity

(a) Hard to Clean Out

(i) Easy
(ii) Medium
(iii) Difficult

(b) Solubility

Group Descriptive Terms Parts of Solvent required for 1

Part of Solute (As per USP)
1 Very soluble Less than 1
2 Freely Soluble From 1 to 10
3 Soluble From 10 to 30
4 Sparingly soluble From 30 to 100
5 Slightly soluble From 100 to 1000
6 Very slightly soluble From 1000 to 10,000
7 Practically insoluble, or insoluble 10,000 and over

(c) Toxicity

Group Descriptive Terms Probable oral lethal

dose (mg/kg)
1 Practically nontoxic >15,000
2 Slightly toxic 5000 -15,000
3 Moderately toxic 500 – 5000
4 Very toxic 50 – 500
5 Extremely toxic 5 – 50
6 Super toxic <5

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