Pharmaceutical Grade NaCl
USP and BP compliant sodium chloride for saline solutions, IV infusions, dialysis, eye drops, nasal sprays, and API manufacturing. GMP-produced, third-party tested, full pharmacopoeial documentation.
Sub-Industries Served
- IV Saline Solutions (0.9% NaCl)
- Dialysis
- API Manufacturing
- Eye Drops & Nasal Sprays
- Hospital Sterilization
- Injection-grade NaCl
Recommended Grades & Grain Sizes
Grades
Grain Sizes
Typical Specifications Required
| Parameter | Typical Requirement | Note |
|---|---|---|
| NaCl Purity | ≥ 99.5% (USP/BP) | Meets United States Pharmacopeia & British Pharmacopoeia |
| Grain Size | Powder < 0.3 mm / Fine 0.3–1 mm | Powder for saline solutions; fine for dosage forms |
| Moisture | < 0.05% | Loss on drying at 105°C per USP/BP test |
| Heavy Metals (Pb) | < 0.5 mg/kg | USP <231> heavy metals test |
| Arsenic (As) | < 0.1 mg/kg | Per BP/Ph. Eur. limits |
| Sulfate (SO₄²⁻) | < 300 mg/kg | USP limit for pharmaceutical grade |
| Calcium + Magnesium | < 100 mg/kg | As CaCO₃ equivalent per BP |
| Appearance | White crystalline powder | Visual inspection per USP/BP |
| pH (5% solution) | 6.0 – 7.0 | USP pH specification |
| Endotoxins | On request (LAL test) | For injectable/sterile applications |
USP & BP Compliant
Our pharmaceutical NaCl complies with USP <1231> and BP monograph. Full CoA with test results against all pharmacopoeial limits.
GMP Manufacturing
Pharmaceutical-grade production lines operated under Good Manufacturing Practice (GMP). Dedicated equipment, controlled environment, batch traceability.
Third-Party Testing
Independent laboratory analysis by accredited EU labs. XRF trace element analysis, ICP-MS heavy metals, particle size distribution per lot.
Saline Solution Grade
0.9% NaCl (isotonic), 3% (hypertonic), 0.45% (hypotonic) — all start with our ultra-pure pharmaceutical NaCl meeting endotoxin and sterility pre-requirements.
Dialysis Applications
Hemodialysis and peritoneal dialysis concentrate production requires ultra-pure NaCl with strict limits on all metal ions. Our pharma grade meets these requirements.
API Manufacturing
Sodium chloride as starting material or excipient for active pharmaceutical ingredient (API) synthesis. Full documentation package for regulatory submissions.
Products for Pharmaceutical Grade
All productsPharmaceutical NaCl Sea Salt — Fine
Pharmaceutical Rock Salt — NaCl Powder Ultra-Pure
USP Saline-Grade Sea Salt — Ultra-Pure
EP Injection-Grade Rock Salt — Ultra-Pure
Ready to Source Pharmaceutical Grade Salt?
Send us your specification — grade, grain size, quantity, destination port, and packing format. We respond within 24 hours.