In order to reduce the effect of sampling bias in qualitative and quantitative results, it is necessary to ensure that the composition of the sample used be representative of the batch of drugs being examined. The following sampling procedures are the minimum considered applicable to vegetable drugs. Some articles, or some tests, may require more rigorous procedures involving more containers being sampled or more samples per container.
Gross Sample
Where external examination of containers, markings, and labels indicates that the batch can be considered to be homogeneous, take individual samples from the number of randomly selected containers indicated below. Where the batch cannot be considered to be homogeneous, divide it into sub-batches that are as homogeneous as possible, then sample each one as a homogeneous batch.
No. of Containers
in Batch (N) |
No. of Containers
to be Sampled (n) |
| 1 to 10 |
all |
| 11 to 19 |
11 |
| >19 |
n = 10 + (N/10) |
(Round calculated “n” to next highest whole number.)
Samples are taken from the upper, middle, and lower sections of each container. If the crude material consists of component parts which are 1 cm or less in any dimension, and in the case of all powdered or ground materials, withdraw the sample by means of a sampling device that removes a core from the top to the bottom of the container, not less than two cores being taken in opposite directions. For materials with component parts over 1 cm in any dimension, withdraw samples by hand. In the case of large bales or packs, samples should be taken from a depth of 10 cm because the moisture content of the surface layer may be different from that of the inner layers.
Prepare the gross sample by combining and mixing the individual samples taken from each opened container, taking care not to increase the degree of fragmentation or significantly affect the moisture content.
Laboratory Sample
Prepare the laboratory sample by repeated quartering of the gross sample.
NOTE—Quartering consists of placing the sample, adequately mixed, as an even and square-shaped heap and dividing it diagonally into four equal parts. The two opposite parts are then taken and carefully mixed. The process is repeated as necessary until the required quantity is obtained.
The laboratory sample should be of a size sufficient for performing all the necessary tests.
Test Sample
Unless otherwise directed in the individual monograph or test procedure below, prepare the test sample as follows:
Decrease the size of the laboratory sample by quartering, taking care that each withdrawn portion remains representative. In the case of unground or unpowdered drugs, grind the withdrawn sample so that it will pass through a No. 20 standard-mesh sieve, and mix the resulting powder well. If the material cannot be ground, reduce it to as fine a state as possible, mix by rolling it on paper or sampling cloth, spread it out in a thin layer and withdraw the portion for analysis.
