Potassium Citrate Pills (Bulk 25kg Packaging) – Pharmaceutical-Grade Dietary Supplements & Medical Formulations
Our Potassium Citrate Pills, packaged in 25kg moisture-proof drums with food-grade HDPE liners and sealed aluminum foil blisters (sub-packaged), deliver a bioavailable, pH-regulating potassium salt of citric acid. With the chemical formula K₃C₆H₅O₇·H₂O (monohydrate) and a molecular weight of ~306.39 g/mol, these white, film-coated tablets adhere to USP 43, EP 10.5, and ICH Q3D guidelines for human consumption.
Key Features
- Precision Dosing: Each tablet contains 99 mg (2.5 mEq) or 540 mg (10 mEq) of elemental potassium, ensuring accurate therapeutic/nutritional intake.
- Extended Stability: Tablets retain ≥95% potency for 36 months when stored below 25°C and 60% RH, verified by accelerated aging tests (ICH Q1A).
- Enteric Coating: pH-dependent film prevents gastric irritation and optimizes absorption in the small intestine.
- Low Excipient Load: Formulated with ≤5% non-active ingredients (microcrystalline cellulose, magnesium stearate), minimizing allergenic risks.
Technical Specifications
- Tablet Appearance: Round, biconvex, white to off-white with debossed "K3"/"K10" markings.
- Tablet Dimensions: 8 mm (99 mg) or 12 mm (540 mg) diameter, ±5% variation.
- Hardness: 6–8 kP (ensures no chipping during packaging/transport).
- Dissolution Profile: ≥85% dissolved within 30 minutes (USP apparatus II, pH 6.8 phosphate buffer).
- Heavy Metal Limits: Pb ≤00.5 ppm, Cd ≤0.1 ppm, Hg ≤0.01 ppm (ICP-MS verified).
- Microbial Limits: TAMC <10³ CFU/g, TYMC <10² CFU/g, E. coli/Salmonella absent (USP <61>/<62>).
Applications
- Pharmaceuticals:
Urolithiasis Prevention: Alkalinizes urine to reduce calcium oxalate/urate stone recurrence (FDA-approved, 10 mEq/day).
Hypokalemia Management: Corrects potassium deficiency in diuretic users or chronic diarrhea patients.
- Nutraceuticals:
Electrolyte Replenishment: Sports hydration mixes, post-workout recovery drinks, and ketogenic diet supplements.
Cardiovascular Health: Synergizes with magnesium to regulate blood pressure (clinical trials: 4.9 g/day potassium citrate reduced SBP by 4–5 mmHg).
- Veterinary Medicine:
Equine Hydration: Electrolyte pastes for endurance horses (combats potassium loss from sweating).
Canine/Feline CKD: Renal-supportive diets (vets recommend 1–2 mg/kg/day).
Factory Strengths
Our 20,000㎡ GMP-certified (ISO 15378) facility employs high-speed rotary tablet presses and inline near-infrared (NIR) analyzers to produce 120 million pills/month. Certified to ISO 14644-1 (Class 8 cleanroom) and WHO GSP, we conduct full-batch traceability via blockchain and offer 24/7 real-time production monitoring for clients.
Why Choose Us?
- Custom Formulations: Adjustable tablet strengths (50–1,080 mg K⁺), coatings (sugar-free, gluten-free), and packaging (bottles, blisters, sachets).
- Regulatory Excellence: DMF filed with FDA, MHRA-audited, and compliant with Brazil's ANVISA, Japan's PMDA, and Saudi FDA.
- Sustainability: Carbon-neutral shipping, recyclable packaging, and 100% renewable energy-powered manufacturing.
- Clinical Support: Co-develop Phase II/III trials with CRO partnerships and provide stability studies for global regulatory submissions.
Contact Us Today to request trial batches, access dissolution profiles, or discuss custom labeling for your markets. Partner with us to deliver science-backed potassium citrate formulations that meet the highest safety and efficacy standards.
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