What is the difference between COC and COA for Dissolution?

what is coc certificate

COC - Certificate of Conformance.

For dissolution testing, the guidelines are specified by the USP, EP and/or JP. This means that all dissolution testers and their accessories must meet the specifications defined in the monograph. These specifications are generally physical and can be measured with the appropriate tools. Thus all baskets, paddles, basket shafts, vessels and any other part of the system should be both defined and measurable within the tolerances specified.

All dissolution accessories should conform to these specifications, and the certification that they do so is known as the COC or Certificate of Conformance. The COC generally defines the tolerances that the accessories are manufactured to and these should fall within those defined by the USP

All QLA dissolution accessories supplied by LabHut are supplied with a COC.

COA - Certificate of Analysis

A COA is far

more stringent than a COC and records the actual physical measurements of each individual accessory or part. This means that each part is separately measured and recorded by the manufacturer. The COA exceeds the COC in that it is possible to know the exact measurements and therefore record those for individual test positions.

Because producing a COA is quite time consuming and involved, there is generally an additional charge for those.

How are Accessories Measured?

In addition to using certified and traceable measurement tools, more sophisticated equipment is employed to ensure that all parts meet very tight manufacturing tolerances. Products such as optical comparators are used to compare manufactured parts with perfect originals, and normal tolerances are far tighter than defined in the USP to ensure part to part consistency. This is important to ensure reproducible results between each test position.

Source: www.labhut.com

Category: Insurance

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