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    Home > Chemicals Industry > Chemical Technology > Powder inspection method

    Powder inspection method

    • Last Update: 2022-06-26
    • Source: Internet
    • Author: User
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    The quality requirements of the powder: it should be dry, loose, uniformly mixed, and consistent in color
    .
    In addition to the inspection items specified under each category, the particle size, uniformity of appearance, moisture, difference in filling quantity or filling quantity, sterility and microbial limit should also be checked
    .

    (1) Granularity inspection

    1.
    Brief description This method is applicable to the particle size inspection of local Chinese medicine powders for treating burns or severe traumas and Chinese medicine powders for pediatrics.
    The purpose is to control the particle size of powder powders
    .

    2.
    Method of operation

    (1) Measure according to the particle size and particle size distribution method (General Rule 0982 single sieving method)
    .

    (2) Take 10g of the test product, weigh it, and place it in a No.
    6 drug sieve, cover the sieve, and have a tight receiving container under the sieve
    .

    (3) Rotate and shake in the horizontal direction for at least 3 minutes, and tap the sieve in the vertical direction from time to time
    .

    (4) Take the powder in the receiving container under the sieve, weigh it, and calculate the percentage
    .

    3.
    Matters needing attention

    (1) The medicine sieve, sieve lid and receiving container under the sieve must be dry
    .

    (2) There must be a tight receiving container under the sieve to avoid powder loss during rotation and shaking
    .

    (3) The powder under the sieve should be collected and weighed
    .

    4.
    Results and judgment The weight of the powder passing through the No.
    7 screen is not less than 95%, and it is judged to meet the requirements
    .

    5.
    Records and calculations

    (1) Record the model of the analytical balance
    .

    (2) Record the data of each weighing
    .

    (3) Calculate the percentage based on the weight of the powder passing through the No.
    7 sieve divided by the sample size of the test product
    .

    (2) Uniformity of appearance

    1.
    Brief description This law is applicable to the inspection of the appearance uniformity of powders
    .
    The purpose of this inspection is to control the uneven mixing and inconsistent color of the powder during the production process
    .

    2.
    Method of operation Take an appropriate amount of the test product, place it on a smooth paper, and spread it about 5cm², flatten its surface, observe in a bright place, it should be uniform in color, without patterns and spots
    .

    3.
    Matters needing attention Move the flat surface of the test sample to a bright place for observation
    .

    4.
    Results and Judgment The test product exhibits a uniform color, without patterns and stains, and is judged to meet the requirements
    .

    5.
    Record the appearance, color, pattern and stain of the test product
    .

    (3) Moisture check

    1.
    Brief description This law is applicable to the moisture inspection of powders.
    The purpose of this inspection is to control the moisture brought into the powders during the production process or during storage
    .

    2.
    Operation method Take an appropriate amount of the content of the test product, and operate according to the method under each corresponding item of the Chinese herbal medicine moisture determination method (General Rule 0832)
    .

    3.
    The precautions are the same as the corresponding methods of the Chinese herbal medicine moisture determination method
    .

    4.
    Results and judgment The water content of the test product did not exceed 9.
    0%, and it was judged to meet the requirements
    .

    5.
    Records and calculations are the same as the corresponding methods of the Chinese herbal medicine moisture determination method
    .

    (4) Checking the difference in loading

    1.
    Brief description This law is applicable to the inspection of the difference in filling quantity of single-dose packaged powders
    .
    The purpose of this inspection is to control the consistency of the filling volume between the bags (bottles) and to ensure the accuracy of the dosage
    .

    2.
    Method of operation

    (1) Take 10 bags (bottles) of the test sample, weigh them separately, open the seal, pour out the contents, and then weigh the weight of each empty packaging bag (bottle) separately to obtain each bag (bottle) The installed quantity and the average installed quantity
    .

    (2) Compare the volume of each bag (bottle) with the labeled volume or the average volume
    .

    3.
    Matters needing attention

    (1) When weighing, the contents of each bag (bottle) should be poured out completely
    .

    (2) Do not directly touch the test product with your fingers during the weighing process
    .

    4.
    Results and Judgment

    (1) Comparing the volume of each bag (bottle) with the labeled volume (compared with the average volume of the unlabeled volume), according to the provisions of Table 15-20, the volume difference limit is not exceeded; or the volume is exceeded If the difference limit is not more than 2 bags (bottles), and none of them exceeds the filling difference limit by 1 time, they are all judged to comply with the regulations
    .

    (2) If more than 2 bags (bottles) exceed the limit of the difference in filling quantity, or if the difference exceeds the limit of filling quantity not more than 2 bags (bottles) but one bag (bottle) exceeds the limit of filling quantity by 1 time, both It was judged not to meet the regulations
    .

    Table 15-20 Limits for the difference in the quantity of single-dose packaging powders

    5.
    Records and calculations

    (1) Record the model of the analytical balance
    .

    (2) Record each weighing data
    .

    (3) Calculate the weight of the contents of each bag (bottle)
    .

    (4) Calculate the allowable loading range based on the indicated loading volume or average loading volume
    .

    (5) Checking the quantity

    1.
    Brief description This law is applicable to the inspection of the quantity of multi-dose packaged powders.
    The purpose of this inspection is to control the minimum quantity of powders
    .

    2.
    The operation method is in accordance with the minimum loading inspection method (general rule 0942 weight method)
    .

    3.
    Matters needing attention

    (1) In the two weighings of each test product, attention should be paid to the sequence of numbers and the matching of empty containers
    .

    (2) Do not directly touch the test product with your fingers during the weighing process
    .

    4.
    Results and Judgment

    (1) The filling and average filling of the contents of each container, in accordance with the minimum filling inspection method (gravity method), the filling of each container is not less than the minimum allowed filling; and the average filling is not less than In the marked quantity, it is judged to meet the requirements
    .

    (2) If one container does not meet the requirements, take another 5 (3 for 50g or more) for retest
    .
    All the results of the retest meet the requirements, but they can still be judged as in compliance
    .

    (3) The average filling quantity and the filling quantity of each container (calculate the percentage according to the marked filling quantity), and take three significant figures to judge the result
    .

    5.
    Records and calculations

    (1) Record the model of the analytical balance
    .

    (2) Record the weighing data of the contents of each container, the weight of each test product and the weight of its own empty container
    .

    (3) Divide the total volume of each container by 5 (or 3) to get the average volume
    .

    (4) Calculate the volume and average volume of the contents of each container, and calculate the minimum allowable volume
    .

    (6) Sterility inspection

    Local powders used for burns, severe trauma or clinically necessary, according to the sterility inspection method (general rule 1101) inspection, should meet the requirements
    .

    (7) Microbial limit inspection

    Unless otherwise specified, the microbial limit inspection for powders and non-sterile products: the microbial count method (General Rule 1105), the control bacteria inspection (General Rule 1106) and the microbiological limit standard for non-sterile drugs (General Rule 1107) inspection shall meet the requirements
    .
    For powders that are required to be checked for bacteria, the microbial limit check is not required
    .

     

     

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