Medical use of sodium gluconate:
Basic steps: First, check the physical properties such as appearance, color, smell, and taste of the drug, then perform identification and impurity inspection, and finally determine the content.
1. General inspection: 1. Weight difference test; 2. Disintegration time limit test; 3. Tablet thickness and diameter uniformity test; 4. Hardness testing, etc.
2. Dissolution test: The rate or degree at which a drug dissolves from a tablet (or capsule) in a specified solvent.
3. Content uniformity inspection: Due to the relationship between process and operation, the content of the main drug in the tablet is often uneven.
Determination of tablet content:
1. Direct determination: The main drug content is relatively high, and the method used is not affected by the excipient or can be ignored without timing. Generally, direct determination is used.
Exclusion of excipient interference:
1. Carbohydrates: Hydrolyzed to produce glucose, which can be oxidized by strong oxidants to form sodium gluconate. To eliminate the interference of strong oxidants, cerium sulfate with slightly lower oxidation potential is generally used as a titrant.
2. Magnesium stearate: When the content of magnesium stearate is high and the main drug content is low, there may be interference. Organic solvent extraction, addition of masking agents, and elimination through steam distillation can be used.
3. Talc powder: dissolution filtration method, extraction capacity method.
4. Others such as benzoates, CMC Na, and polyvinylpyrrolidone may also interfere.
（3） Calculation of tablet content results: The percentage content calculated based on the labeled amount=content per tablet/labeled amount × 100%
The basic steps of injection analysis are to observe the color and clarity, then conduct identification tests, pH value checks, and finally determine the content.
Routine inspection of injections:
（1） General inspection: clarity test, limit of loading test, pyrogen test, sterility test, etc.
（2） Special inspection:
Insoluble particle inspection.
In rare cases, the quality of the glass needs to be checked.
2. When injection solutions using vegetable oil as a solvent encounter problems, the saponification value, iodine value, and acid value should also be checked.
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