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.
The Brief
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.
Specification
| 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 |
Process
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
Logistics
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.
Outcome
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)
Key Takeaway
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.
Quality at the Core — how this shipment was verified
Every consignment Egypt Globe Group ships passes the same five verification gates. The evidence set below is what the buyer in this case study received; it is the same set issued on every contract, because the group has operated with an internal Quality Assurance division since its 2014 incorporation and treats a lot outside specification as a lot that does not load.
| Gate | Control | Evidence issued | Who · frequency |
|---|---|---|---|
| 1 | Extraction / source | Source sampling on every production lot | Source laboratory · per lot |
| 2 | Processing | Washing, screening, drying, grading or milling verified against the contract specification | Plant QC · per batch |
| 3 | Port laboratory | Full analysis against the contract specification; Certificate of Analysis or Mill Test Certificate issued before the Bill of Lading | EGG port QC lab · per shipment |
| 4 | Independent inspection | Pre-shipment sampling, witness testing, draft survey or tally; sealed retained samples held 90 days | TÜV Austria / SGS / Intertek / BV · per vessel |
| 5 | Destination acceptance | CoA cross-referenced with the buyer's arrival laboratory; retained samples arbitrate any variance | Buyer laboratory · on discharge |
- Quality & compliance — the QA charter, inspection partners and destination conformity programmes
- Inspection & QC · Trade documentation · Loading ports
- Request a quote — priced FOB / CIF / CFR offer, sample Certificate of Analysis and inspection protocol within 24 hours
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