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-25-0862

Product

SAK-CZM18

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

One-pack PVC stabilisers

Batch

B25-0862

Manufactured: 10 Nov 2025
Best before: 10 Nov 2027
Quantity made: 1,469 kg
Works order: WO-2025-0862

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.

This batch went to 2 customers. Issue the certificate for Australian Vinyls Corporation Pty Ltd · Poliveneta S.r.l.

Test	Specification	Result	Off target	Outcome
Yield	97.50 to 100.00 %	99.63 %	—	Pass
Assay	98.00 to 101.50 %	99.94 %	—	Pass
Heavy metals	0.0 to 10.0 ppm	1.5 ppm	—	Pass
Moisture	0.00 to 1.50 %	0.42 %	—	Pass
Metal content	6.20 to 7.40 %	6.89 %	—	Pass
Appearance vs standard	1 to 1 pass	Conforms	—	Pass
Sieve residue 75 µm	0.00 to 0.50 %	0.06 %	—	Pass

Part batches supplied to Australian Vinyls Corporation Pty Ltd

Nothing off this run has been despatched. 403 kg is still on the floor.

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

11 Nov 2025 at 10:53am

Made on BL-01 by Malcolm Rees

Despatched against

Australian Vinyls Corporation Pty Ltd SO-01003 · 410 kg
Poliveneta S.r.l. SO-00808 · 540 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