Pharmaceutical Grade Potassium Citrate Medicinal Grade Potassium Citrate White Crystalline Powder Content 99% and Above 500g per Bottle

Potassium Citrate is an important pharmaceutical excipient widely used in the pharmaceutical industry. As an inorganic salt, potassium citrate exhibits good solubility and biocompatibility, commonly used as a pH adjuster, chelating agent, and potassium ion supplement. According to the "Chinese Pharmacopoeia 2020 Edition (CP Edition)", the quality standards for medicinal grade potassium citrate cover multiple aspects to ensure its safety, efficacy, and stable role in pharmaceuticals.

1. Appearance and Properties

Medicinal grade potassium citrate should be a white crystalline powder or granules, odorless or with a slight acidic odor. Its appearance must be clean and free of visible impurities. Solubility requirements include:

- Solubility: Easily soluble in water, almost insoluble in ethanol.

- Solution Clarity: The pharmacopoeia requires its aqueous solution to be clear and transparent, with no obvious precipitation.

2. Identification

The pharmacopoeia specifies several identification methods for potassium citrate to ensure the excipient used is indeed potassium citrate:

- Ion Reaction: Chemical identification through specific reactions of potassium ions and citrate ions.

- Spectroscopy: Structural verification via infrared or ultraviolet spectroscopy.

3. Assay

The assay of medicinal grade potassium citrate is performed using titration. The CP Edition stipulates that its content should be between 99.0% and 101.0% (calculated on a dried basis). This standard ensures its purity and stability meet pharmaceutical manufacturing requirements.

4. Acidity and Alkalinity (pH)

The pH of the potassium citrate aqueous solution must be controlled between 7.5 and 9.0 (1% solution) to ensure its performance as an acid-base buffer.

5. Loss on Drying

Potassium citrate must meet the pharmacopoeia's strict requirements for moisture content. Through loss on drying testing, its water content must not exceed 1.0%. This indicator is directly related to the stability and hygroscopic resistance of potassium citrate.

6. Heavy Metals

The pharmacopoeia stipulates that the content of heavy metals (such as lead, cadmium, etc.) in medicinal potassium citrate must not exceed 10ppm. This ensures its safety for human use.

7. Arsenic Salts

The arsenic salt content in potassium citrate must be strictly controlled and must not exceed 2ppm to ensure long-term safety and non-toxicity.

8. Microbial Limits

Microbial limit testing for medicinal potassium citrate, including total bacterial count, mold, and yeast content, must comply with pharmaceutical standards. Strict sterility testing is required, especially when used in sterile drug preparations.

Pharmaceutical Grade Potassium Citrate Medicinal Grade Potassium Citrate White Crystalline Powder Content 99% and Above 500g per Bottle

Main products include:
Common excipients for topical preparations: Glycerin/Propylene Glycol, Vaseline/Lanolin, Laurocapram, Stearic Acid, Triethanolamine, Poloxamer 188/407, Polysorbate 80, Polyethylene Glycol Series, Solid Paraffin, Liquid Paraffin (Light/Heavy), Mixed Fatty Acid Glycerides, and other varieties are complete.
Excipients for oral preparations: Honey/Sucrose, Lactose/Aspartame, Hydroxypropyl Beta-Cyclodextrin, Hydroxypropyl Methylcellulose, Methylcellulose, Ethylcellulose, Microcrystalline Cellulose, Povidone K30, Magnesium Stearate, Maltose/Saccharin Sodium/Sucralose/Tranexamic Acid/Stevioside, Gelatin, Pigment Lakes, Flavors, and other varieties are complete.
Excipients for injections: (Endotoxin & Microbial Limits required)
Cholesterol, Trehalose (Anhydrous/Dihydrate), Lecithin/Soybean Phospholipid, Polysorbate (for injection), Citric Acid/Sodium Citrate, Sodium Dihydrogen Phosphate/Dipotassium Hydrogen Phosphate, Lactose (for injection), Disodium Edetate (for injection)
Raw materials for topical disinfection and bacteriostasis:
Chlorhexidine Acetate, Chlorhexidine Gluconate Solution, Benzalkonium Bromide/Benzalkonium Chloride, Menthol/Peppermint Oil, Salicylic Acid/Sodium Benzoate, Vitamin E Oil, Dimethicone, Span 80/85, Methylparaben/Ethylparaben/Propylparaben/Sodium Methylparaben/Sodium Propylparaben, Tromethamine, Chlorobutanol, Dihydroxyaluminum Aminoacetate, etc.