81 World Health Organization who technical Report Series, No. 957, 2010



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pharmaceutical analysis
Part two. Materials, equipment,
instruments and other devices
10.
Reagents
10.1 All reagents and chemicals, including solvents and materials used in tests and assays, should be of appropriate quality Reagents should be purchased from reputable, approved suppliers and should be accompanied by the certifi cate of analysis, and the material safety data sheet, if required In the preparation of reagent solutions in the laboratory:
(a) responsibility for this task should be clearly specifi ed in the job description of the person assigned to carry it out and
(b) prescribed procedures should be used which are in accordance with published pharmacopoeial or other standards where available. Records should be kept of the preparation and standardization of volumetric solutions The labels of all reagents should clearly specify:
(a) content;
(b) manufacturer;
(c) date received and date of opening of the container;
(d) concentration, if applicable;
(e) storage conditions and
(f) expiry date or retest date, as justifi ed.
TRS957.indd 102 21.04.10 11:03


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10.5 The labels of reagent solutions prepared in the laboratory should clearly specify:
(a) name;
(b) date of preparation and initials of technician or analyst;
(c) expiry date or retest date, as justifi ed and
(d) concentration, if applicable The labels for volumetric solutions prepared in the laboratory should clearly specify:
(a) name;
(b) molarity (or concentration);
(c) date of preparation and initials of technician/analyst;
(d) date of standardization and initials of technician/analyst; and
(e) standardization factor.
Note: The laboratory should ensure that the volumetric solution is suitable for use at the time of use In the transportation and subdivision of reagents:
(a) whenever possible they should be transported in the original containers and
(b) when subdivision is necessary, clean containers should be used and appropriately labelled.

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