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-25-0777

Product

SAK-CZM18

SAK-CZM 18 · Ca/Zn one pack, medical film

One-pack PVC stabilisers

Batch

B25-0777

Manufactured: 06 Sep 2025
Best before: 06 Sep 2027
Quantity made: 1,468 kg
Works order: WO-2025-0777

Pharmacopoeial release

QP-PHARMA

Conforms to specification

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 %	99.44 %	—	Pass
Assay	98.00 to 101.50 %	99.42 %	—	Pass
Heavy metals	0.0 to 10.0 ppm	2.8 ppm	—	Pass
Moisture	0.00 to 1.50 %	0.55 %	—	Pass
Metal content	6.20 to 7.40 %	6.74 %	—	Pass
Appearance vs standard	1 to 1 pass	Conforms	—	Pass
Sieve residue 75 µm	0.00 to 0.50 %	0.18 %	—	Pass

Part batches supplied to Advanced Polymer Industries Pty Ltd

SO-00954 13 Apr 2026 · 784 kg · 1 pallet

B25-0777-P01

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

07 Sep 2025 at 10:27am

Made on BL-01 by Sione Naufahu

Despatched against

Advanced Polymer Industries Pty Ltd SO-00954 · 784 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