41 WEIGHTS AND BALANCES
The intent of this section is to bring the requirements for weights into conformity with American National Standard ANSI/ASTM E617, Laboratory Weights and Precision Mass Standards. This standard is incorporated by reference and should be consulted for full descriptions and information on the tolerances and construction of weights.1
Pharmacopeial tests and assays require balances that vary in capacity, sensitivity, and reproducibility. Unless otherwise specified, when substances are to be accurately weighed for Assay, the weighing is to be performed with a weighing device whose measurement uncertainty (random plus systematic error) does not exceed 0.1% of the reading. Measurement uncertainty is satisfactory if three times the standard deviation of not less than ten replicate weighings divided by the amount weighed, does not exceed 0.001. Unless otherwise specified, for titrimetric limits tests, the weighing shall be performed to provide the number of significant figures in the weight of the analyte that corresponds to the number of significant figures in the concentration of the titrant.
The class designations below are in order of increasing tolerances.
Class 1.1 weights are used for calibration of low-capacity, high-sensitivity balances. They are available in various denominations from 1 to 500 mg. The tolerance for any denomination in this class is 5 µg. They are recommended for calibration of balances using optical or electrical methods for accurately weighing quantities below 20 mg.
Class 1 weights are designated as high-precision standards for calibration. They may be used for weighing accurately quantities below 20 mg. (For weights of 10 g or less, the requirements of class 1 are met by USP XXI class M.)
Class 2 weights are used as working standards for calibration, built-in weights for analytical balances, and laboratory weights for routine analytical work. (The requirements of class 2 are met by USP XXI class S.)2
Class 3 and class 4 weights are used with moderate-precision laboratory balances. (Class 3 requirements are met by USP XXI class S-1; class 4 requirements are met by USP XXI class P.)2
A weight class is chosen so that the tolerance of the weights used does not exceed 0.1% of the amount weighed. Generally, class 2 may be used for quantities greater than 20 mg, class 3 for quantities of greater than 50 mg, and class 4 for quantities of greater than 100 mg. Weights should be calibrated periodically, preferably against an absolute standard weight.
1 Copies of ASTM Standard E 617-81 (Reapproved 1985) may be obtained from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103.
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USP35NF30 Page 52Pharmacopeial Forum: Volume No. 36(2) Page 454