Pharmaceutical grade potassium citrate for the treatment of hypokalemia, with usage and dosage instructions, 500g per bottle.

Pharmaceutical Grade Potassium Citrate for Treating Hypokalemia and Usage/Dosage of Pharmaceutical Grade Potassium Citrate 500g per Bottle

According to the "Chinese Pharmacopoeia 2020 Edition," the quality standards for pharmaceutical grade potassium citrate are as follows:
- Description: White granular crystals or crystalline powder; odorless; slightly hygroscopic. Freely soluble in water or glycerol, almost insoluble in ethanol.
- Identification: Exhibits identification reactions for potassium salts and citrate salts.
- Tests:
- Acidity or alkalinity: Dissolve 2.0g in 25ml of water, add 1 drop of thymol blue indicator solution. If a blue color appears, add 0.20ml of titrant (0.1mol/L), and the color should change to yellow; if 0.20ml of sodium hydroxide titrant (0.1mol/L) is added, the color should change to blue.
- Chloride: Take 0.20g and examine as directed. Compare with a control solution prepared from 7.0ml of standard sodium chloride solution; the sample should not be more concentrated (0.035%).
- Sulfate: Take 0.20g and examine as directed. Compare with a control solution prepared from 3.0ml of standard potassium sulfate solution; the sample should not be more concentrated (0.15%).
- Readily carbonizable substances: Take 0.50g, add 5ml of sulfuric acid (containing 94.5%–95.5% H₂SO₄), heat in a water bath for 1 hour, and immediately cool. Examine as directed and compare with a control solution (prepared by mixing 0.5ml of cobalt chloride solution for color comparison with 4.5ml of sulfuric acid for color comparison); the sample should not be darker.
- Oxalate: Dissolve 1.0g in 1ml of water and 3ml of dilute acid, add 4ml of 90% ethanol and 4 drops of calcium chloride test solution, and let stand for 1 hour. No turbidity should develop.
- Water: Take about 0.1g, accurately weighed, add 70ml of anhydrous methanol, stir for 5 minutes, and determine according to the water determination method. The water content should be 4.0%–7.0%.
- Heavy metals: Dissolve 2.0g in 10ml of water, add 5ml of dilute acetic acid and sufficient water to make 25ml, and examine as directed. The heavy metal content should not exceed 10 parts per million.
- Arsenic: Dissolve 1.0g in 23ml of water, add 5ml of hydrochloric acid, and examine as directed. It should comply with the requirement (0.0002%).
- Assay: Take about 80mg, accurately weighed, add 20ml of glacial acetic acid and 2ml of acetic anhydride, heat to dissolve, cool, add 1 drop of crystal violet indicator solution, and titrate with titrant (0.1mol/L) until the solution turns blue. Correct the titration result with a blank test. Each 1ml of titrant (0.1mol/L) is equivalent to 10.21mg of C₆H₅K₃O₇. Calculated on the anhydrous basis, the content of C₆H₅K₃O₇ should not be less than 99.0%.

Pharmaceutical Grade Potassium Citrate for Treating Hypokalemia and Usage/Dosage of Pharmaceutical Grade Potassium Citrate 500g per Bottle

Pharmaceutical grade potassium citrate (Potassium Citrate) is a medication that supplements potassium ions and regulates acid-base balance in the body. It is primarily used for treating hypokalemia, urine alkalinization, and related conditions. Below are its functions, usage methods, and precautions:

I. Main Functions of Pharmaceutical Grade Potassium Citrate

1. Corrects Hypokalemia

- Mechanism: Supplements potassium ions (K⁺), restores electrolyte balance inside and outside cells, and alleviates symptoms such as muscle weakness, arrhythmia, and intestinal paralysis caused by potassium deficiency.

- Applicable Situations:

- Hypokalemia due to inadequate diet, vomiting, diarrhea, diuretic use, renal tubular acidosis, etc.

- Prevention or treatment of potassium loss during long-term use of potassium-wasting diuretics (e.g., furosemide).

2. Urine Alkalinization and Stone Prevention

- Mechanism: Citrate ions bind with urinary calcium, reducing the formation of calcium oxalate and urate crystals. It also increases urine pH (alkalinizing urine), inhibiting the formation of uric acid and cystine stones.

- Applicable Situations:

- Prevention and adjunctive treatment of uric acid stones and cystine stones.

- Urine pH regulation in patients with metabolic acidosis.

3. Corrects Metabolic Acidosis

- Citrate is metabolized in the body to generate bicarbonate (HCO₃⁻), replenishing alkali reserves. It is used to treat metabolic acidosis caused by chronic kidney disease, renal tubular acidosis, etc.