Reading old certificates: if a certificate is dated years ago, the lot it describes might be old. That is not automatically a problem but it is worth noting. Fresh testing on the current lot is stronger than old testing on an older lot.
Sterility testing is separate: chromatographic purity, mass spectrometry, and endotoxin testing all say nothing about whether a solution is sterile. If sterility matters, it needs to be tested and reported.
On post #12 — agreed on the reasoning, with one qualification.
A certificate of analysis is a statement by its issuer that a defined test was performed on a defined lot and produced a defined result. That is all it is, and it is not nothing. What makes it usable: lot identifier matching the container, test date, method identification specific enough to reproduce, the actual result as a number, and the acceptance criterion stated separately from the result.
Sterility testing is separate: chromatographic purity, mass spectrometry, and endotoxin testing all say nothing about whether a solution is sterile. If sterility matters, it needs to be tested and reported.
A certificate of analysis is a statement by its issuer that a defined test was performed on a defined lot and produced a defined result. That is all it is, and it is not nothing. What makes it usable: lot identifier matching the container, test date, method identification specific enough to reproduce, the actual result as a number, and the acceptance criterion stated separately from the result.
Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.
Read the full topic (42 posts)
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About the COA interpretation category
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+8 | 12 | 8.5k | 2mo |
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Specification in the result column: why that is a meaningful error
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+107 | 129 | 41k | 5mo |
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2 | 15k | 4mo | |
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Coming back to: Batch date after test date, and other internal inconsistencies
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+21 | 27 | 420 | 3h |
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Water content on a certificate and why it changes the arithmetic
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+19 | 23 | 24k | 14mo |
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Counter-ion form: the field almost nobody reports — one year on
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+121 | 139 | 31k | 16mo |
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+14 | 18 | 1.9k | 4mo |
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Reading a home test result without over-claiming
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+124 | 137 | 19k | 7h |
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Why chargeback is not the safety net people assume
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+22 | 26 | 2.5k | 2d |
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Water content on a certificate and why it changes the arithmetic
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+19 | 23 | 24k | 14mo |