B25-0777

Pass Main Store

SAK-CZM18, SAK-CZM 18 · Ca/Zn one pack, medical film. 1,475 kg made on 10 Sep 2025 against WO-2025-0777, 151 kg still on the floor, best before 10 Sep 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-5040 Calcium stearate, bought-in, blending grade	FAC-2403740	Faci Asia Pacific Pte Ltd	363
RM-3050 Epoxidised soybean oil, ESBO	CHE-2602119	Chemiplas Australia Pty Ltd	267
RM-2024 Zinc oxide, pharmaceutical grade	IMC-2511934	IMCD Australia Ltd	156
RM-3016 Zeolite 4A, low sodium, pharma	SIN-2610889	Sinochem Plastics Co. Ltd	123
RM-3060 Glycerol monostearate, GMS 40	PGR-2612921	Peter Greven GmbH & Co. KG	132
RM-6010 Calcium carbonate, precipitated, coated	OMY-2401522	Omya Australia Pty Ltd	144
RM-3040 Pentaerythritol, mono, 98%	SIN-2512237	Sinochem Plastics Co. Ltd	69
RM-4010 Phenolic antioxidant 1010, bulk	SON-2612816	Songwon Industrial Co. Ltd	24
Charged into the batch			1,278 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.

Sales order	Customer	Despatched	kg
SO-00971	Poliveneta S.r.l. Vicenza IT	13 May 2026	993
Despatched · remaining			993 · 151 kg

Release record · Pharmacopoeial release

Tested 11 Sep 2025 by Karen Doust. Full monograph assay with retained sample. Certificate of analysis issued with every despatch.

Pass

Yield 99.12 % 97.5-100

Assay 100.15 % 98-101.5

Heavy metals 3.6 ppm 0-10

Moisture 0.63 % 0-1.5

Metal content 6.70 % 6.2-7.4

Appearance vs standard Pass visual

Sieve residue 75 µm 0.16 % 0-0.5

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

B25-0777

Grade: SAK-CZM18
Manufactured: 10 Sep 2025
Best before: 10 Sep 2027
Quantity: 1,475 kg

Sun Ace Australia Pty Ltd certifies that batch B25-0777 of SAK-CZM18, SAK-CZM 18 · Ca/Zn one pack, medical film, 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	99.12 %	97.5-100 %	SA-QC-YIEL
Assay	100.15 %	98-101.5 %	SA-QC-ASSA
Heavy metals	3.6 ppm	0-10 ppm	SA-QC-HEAV
Moisture	0.63 %	0-1.5 %	SA-QC-MOIS
Metal content	6.70 %	6.2-7.4 %	SA-QC-META
Appearance vs standard	Pass	Pass	SA-QC-APPE
Sieve residue 75 µm	0.16 %	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 Karen Doust

Date