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Certificate of Analysis, Batch and Retest Date
The Certificate of Analysis (CoA) is an evidence of certain substance batches used that meet the general or specific standards of the Pharmacopoeia or certain other validated test methods.
One batch comprises one production unit each.
There is also a retest date for each batch. This indicates the minimum shelf life for the product.
While the specification defines charge-independent the test parameters for a particular article, the AZ depicts the actual state of the respective batch.
Each batch consists of one production unit. Thus, a group of containers whose contents are completely identical because they come from the same production batch (prepared under the same conditions) were cleaned together or bottled / packaged from a large pot into small bottles. Each batch is assigned a unique batch number, from which conclusions can be drawn on the production date, the associated production record and the raw materials used (of course redefined with a batch number). Only the complete assignment of batch numbers allows batch tracking. With the help of the batch number in case of complaint 1. The production error can be found more easily and 2. Defective goods are intentionally destroyed or returned by the buyer.
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There is also a retest date for each batch. This indicates the minimum shelf life for the product. This means that until the expiry date of the retest date, we guarantee that the correctly labeled and closed containers will meet the values stated in the Certificate of Analysis and that the chemical can be safely used. So why do not we just write "expiry date" or "best before"? After the expiration date, the product is generally not broken. Most chemicals last much longer. It is up to the user to decide whether the product is still usable or not. And it does exist, the "retest"! If we still have containers in stock from a batch, we can extend the shelf life after intensive testing. A new Certificate of Analysis will be created with the new "Retest" date and the addition "revised".
While the specification defines the test parameters for a particular article independently of the batch (defines limits in which fluctuations may be allowed), the AZ shows the actual status of the respective batch. In addition to the article data (article number, description, physical data, and storage information), each AZ is uniquely assigned:
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