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
COA-25-0916
Product
SAK-CZM18
SAK-CZM 18 · Ca/Zn one pack, medical film
One-pack PVC stabilisers
Batch
B25-0916
- Manufactured
- 14 Dec 2025
- Best before
- 14 Dec 2027
- Quantity made
- 1,474 kg
- Works order
- WO-2025-0916
Pharmacopoeial release
QP-PHARMA
Full monograph assay with retained sample. Certificate of analysis issued with every despatch.
Tested against
The published specification for SAK-CZM18, released under QP-PHARMA.
| Test | Specification | Result | Off target | Outcome |
|---|---|---|---|---|
| Yield | 97.50 to 100.00 % | 99.79 % | — | Pass |
| Assay | 98.00 to 101.50 % | 99.73 % | — | Pass |
| Heavy metals | 0.0 to 10.0 ppm | 3.4 ppm | — | Pass |
| Moisture | 0.00 to 1.50 % | 0.58 % | — | Pass |
| Metal content | 6.20 to 7.40 % | 6.96 % | — | Pass |
| Appearance vs standard | 1 to 1 pass | Conforms | — | Pass |
| Sieve residue 75 µm | 0.00 to 0.50 % | 0.13 % | — | Pass |
Part batches supplied to Welvic Australia Pty Ltd
- SO-00914 15 Mar 2026 · 593 kg · 1 palletB25-0916-P02
2 pallets came off this run. Each carries its own label, so a claim can be answered against the pallets that were delivered rather than the whole batch.
Released by
Priya Raman
15 Dec 2025 at 10:19am
Made on BL-01 by Sione Naufahu
Despatched against
- Welvic Australia Pty Ltd SO-00914 · 593 kg
- The goods described were manufactured under a quality system certified to ISO 9001:2015.
- A retained sample of this batch is held for the shelf life of the product.
Sun Ace Australia Pty Ltd, ABN 52 006 388 102. Results of testing carried out on the batch named above under quality plan QP-PHARMA. Results relate only to the batch tested. COA-GENERAL