Inspection method of glue and alcohol

Glue

The quality requirements of the glue: it should be a translucent solid with uniform color and no abnormal odor, except for the inspection items specified under each category

(1) Moisture inspection

1.

2.

3.

4.

5.

(2) Microbial limit inspection

Except as otherwise specified, the microbial limit inspection of non-sterile products of the glue: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and non-sterile drug microbial limit standard (General Rule 1107) inspection should meet the requirements

Alcohol

Relevant quality requirements for wine preparations: In addition to the inspection items specified under each category, total solids, ethanol content, methanol content, loading volume, and microbial limit should also be checked

(1) Total solid inspection

1.

(1) This law applies to the total solids inspection of alcoholic beverages.

(2) For alcohol containing sugar and honey, check according to the first method

2.

(1) The first method (alcohol containing sugar and honey):

1) Use a pipette to accurately measure 50ml of the supernatant of the test product, place it in an evaporating dish, steam on a water bath to a thick paste, add anhydrous ethanol and stir to extract 4 times, 10ml each time, filter, combine the filtrate, and place It has been dried to a constant weight in an evaporating dish, and steamed to near dryness

2) Precisely add 1g of diatomaceous earth to the above residue (dry at 105°C for 3 hours, transfer to a desiccator to cool for 30 minutes), stir evenly with a glass rod that has been dried to a constant weight, and dry at 105°C After 3 hours, cool in a desiccator for 30 minutes, and quickly and accurately weigh it

(2) The second method (no sugar or honey alcohol): Use a pipette to accurately measure 50ml of the supernatant of the test product, place it in an evaporating dish that has been dried to a constant weight, and evaporate it to dryness on a water bath.

3.

(1) During the storage period of wine, a small amount of easily scattered precipitate is allowed.
Before sampling, the test product should be shaken, and after a certain period of time, the supernatant of the test product should be accurately measured
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(2) When using the first method to check the total solids, the glass rod and the empty evaporating dish should be kept at constant weight at the same time.
After stirring with the glass rod, residues and diatomaceous earth are often adhered, so the glass rod should still be placed in the evaporating dish.
Constant weight in the middle
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4.
Results and judgement If the remaining residue meets the limits specified under each category, it shall be judged as conforming to the regulations
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5.
Records and calculations

(1) Record the model of the analytical balance
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(2) Record the weighing data of the constant weight of the empty evaporating dish, the added amount of diatomaceous earth, and the weighing data of the remaining residue and the constant weight of the evaporating dish
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(3) The amount of diatomaceous earth added should be deducted from the calculation of total solids of sugar and mead (Method 1):

(4) Calculation of total solids without sugar and mead (Method 2):

(2) Check the amount of ethanol

1.
Brief description

(1) This law is applicable to the inspection of the amount of ethanol in alcoholic beverages.
The purpose of this inspection is to control the content of ethanol to ensure the quality of medicines
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(2) The amount of ethanol can be checked by gas chromatography or distillation to determine the content of ethanol in alcoholic beverages
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2.
The method of operation shall be carried out in accordance with the method under the method of ethanol content determination (General Principle 0711 Gas Chromatography or Distillation)
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3.
Matters needing attention

(1) In the chromatogram of the test solution containing no internal standard substance, no impurity peak should appear at the position corresponding to the peak of the internal standard substance
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(2) Unless otherwise specified, if the result of the distillation method is inconsistent with the gas chromatography method, the result of the gas chromatography method shall prevail
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(3) If the distillate of any method is turbid during the measurement by distillation method, add talc or calcium carbonate to shake, filter, make the solution clear, and then measure the relative density
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(4) If foam occurs during distillation , add sulfuric acid or phosphoric acid to the test product to make it strong acid, or add a little excess of calcium chloride solution, or add a small amount of paraffin before distillation
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4.
The result and judgment are in compliance with the regulations under each category, and it is judged to be in compliance
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5.
Records and calculations are the same as the determination of ethanol content
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(3) Check the amount of methanol

1.
Brief description

(1) This law is applicable to the inspection of the amount of methanol in alcoholic beverages.
The purpose of this inspection is to control the content of methanol to ensure the quality of the medicine
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(2) The amount of methanol is checked by gas chromatography
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2.
The operation method is in accordance with the methanol content inspection method (General Principle 0871 Method 1 Capillary Column Method) or the second method (Packed Column Method)
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3.
Matters needing attention If the impurity peak appears at the corresponding position of the internal standard substance peak when the packed column method is used, the external standard method can be used instead
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4.
Results and Judgment Unless otherwise specified, if the methanol content of the test solution does not exceed 0.
05% (v/v), it is judged to meet the requirements
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5.
Records and calculations are the same as the methanol amount inspection method
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(4) Checking the quantity

1.
Brief introduction This law is applicable to the inspection of the volume of alcoholic beverages.
The purpose of this inspection is to ensure the accuracy of the dosage of the medicine
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2.
The operation method is in accordance with the minimum loading inspection method (general rule 0942 volume method)
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3.
Precautions The graduated cylinder used should be clean, dry, and calibrated regularly; its maximum capacity should be consistent with the labelled volume of the test product, or no more than twice the labelled volume
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4.
Results and Judgment

(1) The filling quantity and average filling quantity of the contents of each container shall be in accordance with the minimum filling quantity inspection method (volume method).
The filling quantity of each container shall not be less than the allowable minimum filling quantity; and the average filling quantity shall not be less.
In accordance with the marked quantity, it is judged to be in compliance with the regulations
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(2) If one container does not meet the requirements, another 5 (3 for 50ml or more) shall be taken for retest
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All the results of the retest meet the requirements, but they can still be judged as in compliance
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(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
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5.
Records and calculations are the same as the minimum loading inspection method (volume method)
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(5) Microbial limit inspection

Unless otherwise specified, the microbiological limit inspection of non-sterile products of alcoholic beverages: microbial counting method (General Rule 1105) and control bacteria inspection (General Rule 1106) and non-sterile drug microbiological limit standard (General Rule 1107) inspection, except for the number of bacteria per 1ml shall not exceed 500cfu, and the number of molds and yeasts shall not exceed 100cfu per 1ml.
Others shall comply with the regulations
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