B25-0892
Fail QuarantineACE-MGS20-PH, ACE-MGS 20 PH · magnesium stearate, pharmaceutical grade. 1,938 kg made on 20 Nov 2025 against WO-2025-0892, 1,938 kg still on the floor, best before 20 Nov 2027.
← Backward trace
Every raw material lot consumed into this batch, and the supplier it came from. If a supplier recalls a lot, this is the list of batches it touched.
| Raw material | Supplier lot | Supplier | kg |
|---|---|---|---|
| RM-1010 Stearic acid, triple pressed, vegetable | KLK-2412183 | KLK OLEO (Malaysia) Sdn Bhd | 1,596 |
| RM-2032 Magnesium oxide, USP pharmaceutical | IMC-2405441 | IMCD Australia Ltd | 376 |
| RM-6040 Precipitated silica, anti-caking | SIB-2407466 | Sibelco Australia Ltd | 28 |
| Charged into the batch | 2,000 kg | ||
Forward trace →
Every despatch this batch went out on. If a customer raises a complaint against a batch number, this is who else received it.
Nothing shipped: the batch failed release and is segregated in Quarantine.
Release record · Pharmacopoeial release
Tested 21 Nov 2025 by Priya Raman. Full monograph assay with retained sample. Certificate of analysis issued with every despatch.
Out of specification. Batch transferred to Quarantine pending a rework or concession decision.
SUNACE
Australia · Leading through quality
Sun Ace Australia Pty Ltd
32-38 Remington Drive, Dandenong South VIC 3175
ABN 52 006 388 102 · +61 3 9702 9444 · sunace@sunace.com.au
Certificate of analysis
B25-0892
- Grade
- ACE-MGS20-PH
- Manufactured
- 20 Nov 2025
- Best before
- 20 Nov 2027
- Quantity
- 1,938 kg
Sun Ace Australia Pty Ltd certifies that batch B25-0892 of ACE-MGS20-PH, ACE-MGS 20 PH · magnesium stearate, pharmaceutical grade, was manufactured at Dandenong South under our ISO 9001:2015 quality system and tested against quality plan QP-PHARMA (Pharmacopoeial release) with the following results.
| Test | Result | Specification | Method |
|---|---|---|---|
| Yield | 99.07 % | 97.5-100 % | SA-QC-YIEL |
| Assay | 101.99 % | 98-101.5 % | SA-QC-ASSA |
| Heavy metals | 1.5 ppm | 0-10 ppm | SA-QC-HEAV |
| Moisture | 0.64 % | 0-1.5 % | SA-QC-MOIS |
| Metal content | 6.88 % | 6.2-7.4 % | SA-QC-META |
| Appearance vs standard | Pass | Pass | SA-QC-APPE |
| Sieve residue 75 µm | 0.13 % | 0-0.5 % | SA-QC-SIEV |
Metallic stearate grades are produced from vegetable-based fatty acids and are declared free of animal substances and BSE free. A retained sample is held for 24 months from the date of manufacture. Handle in accordance with the current safety data sheet.
Released by Priya Raman
Date