Pharma-Grade NaCl to South Asian IV Saline Manufacturer — 500 MT USP/BP
How Egypt Globe supplied 500 MT of vacuum-evaporated NaCl meeting USP 43 and BP 2024 monographs to a South Asian IV saline producer — including full GMP documentation and ICH Q3D elemental impurity pack.
A major South Asian IV saline manufacturer required 500 MT of pharmaceutical-grade NaCl compliant with USP 43 and BP 2024 monographs. The buyer's QA team had rejected two previous suppliers on heavy-metals grounds (Pb > 0.5 ppm per ICP-MS). Egypt Globe was approached after a referral from a European API distributor.
| Parameter | USP/BP Limit | Achieved |
|---|---|---|
| NaCl assay | ≥ 99.0% (dried basis) | 99.6% |
| Water content | ≤ 0.5% | 0.18% |
| Lead (Pb) | ≤ 0.5 ppm | < 0.1 ppm |
| Arsenic (As) | ≤ 1.0 ppm | < 0.2 ppm |
| Heavy metals total | ≤ 5 ppm | < 1.0 ppm |
| Conductivity | ≤ 430 µS/cm | 190 µS/cm |
| pH (5% solution) | 6.0 – 7.0 | 6.6 |
Product sourced from a vacuum-evaporation facility in the Nile Delta qualified to EU GMP Annex 15. The facility holds an Egyptian Drug Authority (EDA) manufacturing licence for excipient-grade salts.
Documentation package supplied:
- Certificate of Analysis (batch-specific, QC-signed)
- ICH Q3D elemental impurity report (21 elements, ICP-MS method)
- GMP certificate (EDA-issued)
- Certificate of Origin
- Drug Master File (DMF) reference number
- MSDS, Allergen / GMO / TSE declaration
25 kg multi-wall PE-lined paper sacks, palletised on ISPM-15 certified pine pallets. Shipped FCL (20FT × 2) via Port Said East → Nhava Sheva. Transit: 14 days. Temperature log confirmed 15–25 °C throughout.
Buyer's QA department released the batch in 3 working days — their fastest release for an imported excipient. Egypt Globe is now on the buyer's approved vendor list (AVL). Annual volume contracted: 2,000 MT/yr.
"The heavy metals data was exactly what our QA needed. The DMF reference made the regulatory submission straightforward." — QA Director, IV Solutions Division (name withheld)
Egyptian vacuum-evaporation NaCl can compete head-to-head with European pharma-grade product on specification — at a 15–20% landed-cost advantage into South Asian markets via Port Said East.
Ready for a quote?
FOB / CIF / CFR pricing from 7 Egyptian ports — turnaround within 24 hours.
More in Case Study
Bulk De-icing Salt to Swedish Municipality — 3,500 MT EN 16811-1 Grade A
How we sourced, tested and loaded 3,500 MT of EN 16811-1 Grade A rock salt for a Swedish road authority winter campaign — from Siwa Oasis mine face to Gothenburg port in 38 days.
OPC 42.5N Cement to East Africa — 12,000 MT, 3-Shipment Programme
A Kenyan infrastructure contractor needed 12,000 MT of EN 197-1 CEM I 42.5N cement across three shipments for a highway rehabilitation programme. Egypt Globe delivered on schedule with full MTC and KEBS-compliant documentation.
50,000 MT cement to East Africa under L/C
How Egypt Globe Group shipped 50,000 MT of CEM I 42.5N to a Tanzanian importer over Q3 2025 — Damietta loading, Mombasa discharge, full L/C documentation…
EN 16811-1 Type 1 de-icing salt — Nordic municipal tender
How Egypt Globe Group won a Swedish municipal de-icing tender for 3,500 MT of EN 16811-1 Type 1 (kiln-dried + anti-caking) salt sourced from Siwa Oasis…
Frequently asked questions
How do I request a quote?
Where are your products sourced from?
Other questions? Email our export desk — we respond within 24 hours.