Common use of Release testing of CTM and cleaning verification Clause in Contracts

Release testing of CTM and cleaning verification. The validation of the analytical methods for the release testing of the CTM and for the cleaning verification has already been validated. All analysis will be performed using the validated methods. Except for the cleaning verification all of the analyses are outsourced to a [****] qualified third Party laboratory. Analyses to be performed on CTM are: · appearance, · Identification, · water content (KF), · assay* and degradation products*, · microbiology, · content uniformity, · dissolution** and disintegration time. Cost: 10,965$*** * Assay and Related Substances for the three APIs for RHB-104. ** [****]. *** The cost is not discounted as all of the CTM analyses are outsourced to a Third Party qualified laboratory. The cost includes the analysis of [****] (i.e., RHB-104 capsules), the analysis of [****] for cleaning verification for one GMP manufacturing campaign. Except for the cleaning verification all the analytical methods for release testing have been validated by a third Party [****] qualified laboratory.

Release testing of CTM and cleaning verification. The validation of the analytical methods for the release testing of the CTM and for the cleaning verification has already been validated. All analysis will be performed using the validated methods. Except for the cleaning verification all of the analyses are outsourced to a [****] Corealis qualified third Party laboratory. Analyses to be performed on CTM are: · • appearance, · • Identification, · • water content (KF), · • assay* and degradation products*, · • microbiology, · • content uniformity, · • dissolution** and disintegration time. Cost: 10,965$*** * Assay and Related Substances for the three APIs for RHB-104. ** [****]. *** The cost is not discounted as all of the CTM analyses are outsourced to a Third Party qualified laboratory. The cost includes the analysis of [****] (i.e., RHB-104 capsules), the analysis of [****] for cleaning verification for one GMP manufacturing campaign. Except for the cleaning verification all the analytical methods for release testing have been validated by a third Party [****] Corealis qualified laboratory.