Bulk Pharmaceutical Salt — USP / BP / EP Injection-Grade NaCl
USP / BP / EP sodium chloride from Siwa rock salt and Red Sea sea salt — NaCl ≥ 99.5 % to ≥ 99.85 %, loss on drying ≤ 0.05–0.10 %, monograph panel (heavy metals, bromide, iodide, endotoxin) on every lot CoA, GMP, retain samples. 25 kg sealed bags, 4–8 weeks.
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Pharmaceutical-grade sodium chloride — USP / BP / EP NaCl from Siwa rock salt and Red Sea sea salt
Pharmacopoeial sodium chloride is not a purity tier of industrial salt; it is a separate product with its own monograph tests, controlled storage and a retained sample for every lot. Egypt Globe Group supplies four SKUs. Siwa Oasis and Qattara Depression rock salt — crystalline halite with naturally low calcium, magnesium and sulphate — is the feedstock for the EP injection-grade powder (≥ 99.85 % NaCl) and the USP / BP ultra-pure powder (≥ 99.50 %). Red Sea and North Sinai sea salt, vacuum-evaporated, supplies the USP saline-grade powder (≥ 99.80 %) and the fine pharmaceutical crystal (≥ 99.50 %). All four are produced without anti-caking agents and without iodisation.
End uses are IV saline and dialysis concentrate manufacture, oral rehydration salts, API synthesis and hospital sterilisation. Supply is in 25 kg sealed pharma-grade bags (1 MT FIBC on the fine crystal), 240 MT containerised minimum, 4–8 weeks lead time under GMP conditions. Manufacturers who have qualified a regional supplier on a clean audit lot and then received a lot with 150 ppm sulphate understand why Egypt Globe Group's Quality Assurance division has been at the nucleus of the group since 2014. Specification is guaranteed at the port of loading and binding under the sales contract; a lot outside its CoA is rejected at the port, never re-graded or renegotiated.
Technical specification
Pharmaceutical NaCl — Physical properties
| Parameter | PS-ROCK-PHARM-EP | PS-ROCK-PHARM-P | PS-SEA-PHARM-USP | PS-SEA-PHARM-F | Test method | Standard |
|---|---|---|---|---|---|---|
| Source · processing | Siwa / Qattara rock, purified | Siwa / Qattara rock, vacuum-evaporated | Sea, vacuum-evaporated | Sea, vacuum-evaporated | — | — |
| Pharmacopoeia | EP, BP, USP | USP, BP | USP, BP, EP | USP, BP | Monograph tests | EP / BP / USP |
| Appearance | White crystalline powder | White crystalline powder | Ultra-white free-flowing powder | White free-flowing crystal | Visual | EP / USP |
| Particle size | 0–0.3 mm | 0–0.3 mm | 0–0.5 mm | 0.3–1.0 mm | ISO 13320 / sieve | ISO 13320 |
| Bulk density | 1,250–1,450 kg/m³ | 1,200–1,400 kg/m³ | 1,200–1,400 kg/m³ | 1,200–1,400 kg/m³ | ASTM D7263 / EN 1097-3 | — |
| Loss on drying / moisture | ≤ 0.5 % (EP loss on drying) | ≤ 0.10 % | ≤ 0.05 % | ≤ 0.10 % | Loss on drying, 105 °C | EP 2.2.32 |
| pH (5 % solution) | 7.0–7.5 | 7.0–7.5 | 7.0–7.5 | 7.0–7.5 | ISO 10523 | Acidity / alkalinity, EP |
| Shelf life · storage | 60 months, sealed bags, controlled storage | 60 months | 60 months | 60 months | — | — |
Pharmaceutical NaCl — Chemical analysis
| Parameter | PS-ROCK-PHARM-EP | PS-ROCK-PHARM-P | PS-SEA-PHARM-USP | PS-SEA-PHARM-F | Test method | QA sampling |
|---|---|---|---|---|---|---|
| NaCl (dried basis) | ≥ 99.85 % | ≥ 99.50 % | ≥ 99.80 % | ≥ 99.50 % | Argentometric assay, AOAC 920.179 / ISO 27053 | Per shipment + retain sample |
| Calcium (Ca) | ≤ 0.015 % | ≤ 0.05 % | ≤ 0.02 % | ≤ 0.05 % | ICP / titrimetric | Per shipment + retain sample |
| Magnesium (Mg) | ≤ 0.008 % | ≤ 0.02 % | ≤ 0.01 % | ≤ 0.02 % | ICP | Per shipment + retain sample |
| Sulphate (SO₄) | ≤ 0.04 % | ≤ 0.10 % | ≤ 0.05 % | ≤ 0.10 % | Turbidimetric | Per shipment + retain sample |
| Water insolubles | ≤ 0.01 % | ≤ 0.02 % | ≤ 0.01 % | ≤ 0.02 % | AOAC 925.45 / EN 1936 | Per shipment + retain sample |
| Heavy metals (as Pb) | ≤ 5 ppm | ≤ 5 ppm | ≤ 5 ppm | ≤ 5 ppm | ICP-MS, ISO 17294-2 | Per shipment + retain sample |
| Arsenic (As) | ≤ 1 ppm | ≤ 1 ppm | ≤ 1 ppm | ≤ 1 ppm | ICP-MS | Per shipment + retain sample |
| Iron (Fe) | ≤ 2 ppm | ≤ 2 ppm | ≤ 2 ppm | ≤ 2 ppm | ICP-MS | Per shipment + retain sample |
| Bromides | ≤ 100 ppm | ≤ 100 ppm | ≤ 100 ppm | ≤ 100 ppm | EP monograph | Per shipment |
| Iodides | passes EP test (absent) | passes test | passes test | passes test | EP monograph | Per shipment |
| Ferrocyanides | absent (no anti-caking agent) | absent | absent | absent | EP monograph | Per shipment |
| Bacterial endotoxins (dialysis / parenteral use) | < 5 IU/g | on request | < 5 IU/g | on request | LAL, EP 2.6.14 | Per shipment |
Bromide, iodide, iron, heavy-metal and endotoxin limits are the EP / USP monograph values and are confirmed on the lot CoA; the row values for Ca, Mg, SO₄, insolubles and NaCl are Egypt Globe Group's contractual limits, tighter than the monograph.
Pharmaceutical NaCl — Logistical & QA parameters
| Parameter | Detail |
|---|---|
| MOQ — containerised (FCL) | 240 MT (10 × 20 ft FCL); smaller pallet lots for qualification on request |
| MOQ — break-bulk vessel | 2,000 MT (PS-SEA-PHARM-F and PS-ROCK-PHARM-P only); not offered on powder grades |
| Packing | 25 kg multi-layer bags with sealed PE liner, palletised and shrink-wrapped; 1 MT FIBC with liner on PS-SEA-PHARM-F / PS-SEA-PHARM-USP; batch number and retain-sample reference on every unit |
| Loading ports — rock salt grades | El Dekheila (EGEDK), Alexandria (EGALY), Damietta (EGDAM), Ain Sokhna (EGSOK) |
| Loading ports — sea salt grades | Al-Arish (EGEAR), Port Said East (EGPSE), Damietta (EGDAM), Ain Sokhna (EGSOK) |
| Incoterms | FOB / CFR / CIF; DAP / DDP on request |
| Lead time | 4–6 weeks (PS-ROCK-PHARM-P, PS-SEA-PHARM-F); 6–8 weeks (PS-ROCK-PHARM-EP, PS-SEA-PHARM-USP) |
| Independent inspection protocol | TÜV Austria (primary, EU / GCC), SGS, Intertek, Bureau Veritas — ISO/IEC 17020 + 17025. Witnessed sampling per the pharmacopoeial sampling plan, sealed duplicate samples, container seal and hygiene check. |
| Internal QA gate | GMP batch record and per-lot CoA against the full monograph panel before B/L; retain sample held for the shelf life; lot outside CoA rejected at the loading port |
| HS code | 2501.00.91 (heading 2501.00; pharmacopoeial grade declared on documents) |
QA verification chain
| Gate | Control | Evidence | Who · frequency |
|---|---|---|---|
| Extraction / source | Selection of low-Ca / Mg halite seams (Siwa / Qattara) or controlled-pan brine (Red Sea); raw assay before purification | Source lab log, lot number | EGG QA division · every production lot |
| Processing | Dissolution, brine purification, vacuum recrystallisation, drying and milling under GMP; no additives; in-process SO₄, Ca, Mg, Fe | Batch manufacturing record | EGG QA division · every batch |
| Port laboratory | Full EP / USP monograph panel on the batch composite; retain sample sealed | Per-lot CoA before B/L | EGG port-side QC team · every lot |
| Independent inspection | Witnessed sampling, duplicate samples, packing and seal verification, GMP documentation review | Inspection certificate | TÜV Austria / SGS / Intertek / Bureau Veritas · per shipment on instruction |
| Destination acceptance | Buyer QC release testing against monograph and CoA; specification guaranteed at port of loading | Buyer release record | Buyer · every batch |
Applications & markets
- Pharmaceutical applications — IV saline, dialysis concentrate, ORS, API manufacture
- Industrial chemistry — reagent-grade NaCl for synthesis
- HS 2501 salt export market
Standards & documentation
- European Pharmacopoeia, British Pharmacopoeia and USP monographs for Sodium Chloride; GMP; ISO 9001 for salt suppliers
- Export documentation — Commercial Invoice, Packing List, B/L, Certificate of Origin, per-lot CoA with monograph panel, GMP statement
- Independent inspection · Quality & compliance
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