Reference standards


1 Whenever official reference standards exist, they should be used.

2 Official reference standards should be used only for the purposes described in the appropriate monograph.

3 Reference standards prepared by the producer should be tested, published and stored in the same way as official standards. They should be kept in a safe area under the charge of a designated person.

4 Secondary or working standards may be established by applying appropriate tests and checks at regular intervals to ensure standardization.

5 Reference standards should be properly labeled with at least the following information:
(a) name of the material;
(b) batch or lot number and control number;
(c) date of preparation;
(d) shelf-life;
(e) potency;
(f) storage conditions.

6 All in-house reference standards should be standardized against an official reference standard, when available, initially and at regular intervals thereafter.

7 All reference standards should be stored and used in a manner that does not adversely affect their quality

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