Pharmaceutical / Saline
IV saline, dialysis, injection-grade NaCl, hospital sterilisation. USP / BP / EP / GMP-grade sodium chloride from Siwa rock salt and Red Sea sea salt — NaCl ≥ 99.5 % to ≥ 99.85 %, monograph panel on every lot CoA.
Pharmaceutical-grade NaCl for IV saline, dialysis and injection programmes
IV saline manufacturers, dialysis-fluid producers, hospital sterilization programmes and pharmaceutical compounding labs need ultra-pure NaCl meeting USP, BP, EP and JP monographs. Egypt Globe Group ships pharmaceutical-grade Egyptian salt — Siwa Oasis crystalline rock salt, the high-purity source of the group, refined to ≥ 99.5–99.85 % NaCl, and vacuum-evaporated Red Sea sea salt to ≥ 99.5–99.8 % — produced under GMP-qualified processes for hospital, IV and API customers worldwide.
Pharmaceutical buyers qualify a supplier once and then depend on lot genealogy: every bag must trace to a retained sample and a monograph CoA. The group's Quality Assurance division has run this discipline since incorporation in 2014 — loss on drying, heavy metals, bromide, iodide and endotoxin are tested on every lot at the port laboratory, the CoA is issued before the B/L, retain samples are held, and a lot outside the monograph is rejected at the loading port, never re-graded.
Industry requirements
| Requirement | Typical tender specification | How EGG verifies it | Evidence issued |
|---|---|---|---|
| NaCl assay | ≥ 99.5 % (USP grade) or ≥ 99.8–99.9 % (injection grade) | Argentometric assay per monograph, per lot | CoA before B/L |
| Heavy metals | Pb ≤ 0.5 ppm, As ≤ 0.3 ppm, Cd ≤ 0.1 ppm, Hg ≤ 0.05 ppm | ICP-MS per lot | Monograph panel on CoA |
| Bromide / iodide | Bromide ≤ 100 ppm, iodide ≤ 5 ppm | Monograph tests per lot | CoA |
| pH (50 % solution) | 4.5–7.0 | Potentiometric per lot | CoA |
| Loss on drying | ≤ 0.5 % (USP); ≤ 0.05–0.10 % achieved | Gravimetric per lot | CoA |
| Ca / Mg / SO₄ | Ca ≤ 0.015–0.05 %, Mg ≤ 0.008–0.02 %, SO₄ ≤ 0.04–0.10 % | Monograph tests per lot | CoA |
| Insolubles | ≤ 0.01–0.02 % | Gravimetric per lot | CoA |
| Endotoxin | Per monograph for parenteral grades | LAL test per lot | CoA |
| GMP traceability | Full lot genealogy from feedstock to finished bag; retain samples | Batch record, retain-sample register | Lot genealogy with CoA |
Matched supply
| Product | Grade / spec headline | Division | Standard | MOQ |
|---|---|---|---|---|
| EP injection-grade rock salt — ultra-pure | NaCl ≥ 99.85 %, Ca ≤ 0.015 %, Mg ≤ 0.008 %, SO₄ ≤ 0.04 %, insolubles ≤ 0.01 %, powder 0–0.3 mm | Salt — rock (Siwa) | EP, BP, USP, GMP | 240 MT |
| USP saline-grade sea salt — ultra-pure | NaCl ≥ 99.80 %, LOD ≤ 0.05 %, insolubles ≤ 0.01 %, 0–0.5 mm | Salt — sea (vacuum) | USP, BP, EP, GMP, HACCP | 240 MT |
| Pharmaceutical rock salt — NaCl powder | NaCl ≥ 99.50 %, LOD ≤ 0.10 %, SO₄ ≤ 0.10 % | Salt — rock | USP, BP, GMP | 240 MT |
| Pharmaceutical NaCl sea salt — fine | NaCl ≥ 99.50 %, 0.3–1 mm, LOD ≤ 0.10 % | Salt — sea (vacuum) | USP, BP, GMP | 240 MT |
| Pharmaceutical grade rock salt — NaCl 99.9 % | NaCl ≥ 99.9 % BP / USP / EP — injection / IV saline / dialysis | Salt — rock | ISO 9001, SGS | 240 MT |
| Pharmaceutical rock salt — Egyptian | 99.9 % NaCl — USP / BP standard pharma applications | Salt — rock | ISO 9001, SGS | 240 MT |
| Vacuum-evaporated sea salt — premium | NaCl ≥ 99.50 %, insolubles ≤ 0.02 % — high-purity vacuum-evaporated | Salt — sea (vacuum) | FSSC 22000, FDA | 240 MT |
| Pharmaceutical grade catalogue | 4 monograph SKUs, 25 kg sealed bags, 4–8 weeks | Salt | USP / BP / EP | 240 MT |
Loading ports: rock from El Dekheila (EGEDK), Alexandria (EGALY), Damietta (EGDAM), Ain Sokhna (EGSOK); sea from Al-Arish (EGEAR), Port Said East (EGPSE), Damietta, Ain Sokhna. 25 kg sealed multi-layer bags on ISPM 15 pallets, containerised; FOB / CFR / CIF / DAP. Lead time 4–8 weeks. HS 2501.00.10.
QA verification chain
| Gate | Control | Evidence | Who · frequency |
|---|---|---|---|
| Source | Mine-face assay at Siwa Oasis (rock) or brine assay at Red Sea pans (sea) — NaCl, metals, bromide screen | Source lab report | EGG QA on-site lab · every lot |
| Processing | Recrystallisation / vacuum evaporation, drying, milling under GMP; cleaning validation; retain sample drawn | Batch manufacturing record, retain register | EGG QA · every batch |
| Port laboratory | Full monograph panel: assay, LOD, heavy metals (ICP-MS), bromide, iodide, pH, SO₄, Ca, Mg, insolubles, endotoxin | CoA before B/L; off-spec lot rejected | EGG port-side QC · every lot |
| Independent inspection | GMP-style sampling, sealed retained samples, witness assay, container tally | PSI certificate | TÜV Austria, SGS, Intertek, Bureau Veritas · per shipment on request |
| Destination acceptance | Buyer QC release against monograph and CoA; spec guaranteed at port of loading | Buyer release record | Buyer · per shipment |
Destination markets & compliance
- European pharma compounders (Germany, France, Italy, Spain, Switzerland) — EP / BP, REACH, EUR.1
- South Asian generic manufacturers (India, Bangladesh) — BIS / CDSCO import licence; see the 500 MT USP/BP case study and IV saline manufacturing programme
- MENA hospital + IV plants (KSA, UAE, Egypt) — SFDA / SASO registration, PAFTA origin
- African ORS / WHO programmes — KEBS PVoC (Kenya), COMESA
- Related: food processing · cosmetic & spa
Standards & documentation
- USP 41 / BP 2018 / EP 9.2 / JP XVII Sodium Chloride monograph compliance · ISO 9001:2015 + GMP · WHO Good Manufacturing Practice for Pharmaceutical Products
- Trade documentation · inspection · quality & compliance
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10 products for pharmaceutical / saline
Sourced from 3 of our 7 product divisions.
From Salt (7)
Vacuum-Evaporated Sea Salt — Premium
Pharmaceutical Grade Rock Salt — NaCl 99.9% Ultra-Pure
Pharmaceutical Rock Salt — Egyptian
Pharmaceutical 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
From Construction (1)
Standards & Certifications Covered
SKUs in this application carry paperwork ready for the standards below.
Other applications served
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