Certificate of Analysis

Certificate Number 00071222

LEO Pharma
LEO Laboratories Ltd. Item Description: FUCIDIN® CR 2 % 5 G ID/TUNGGAL IDAMAN
Cashel Road, Crumlin Pack Lot Number: A88234
Dublin 12, Ireland Market: INDONESIA

Bulk Lot Number: A86861

Manufacture Date: 10 2018
Expiry Date: 10 2021

Test Limit Result

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Appearance, a white to off- white cream To Description Conforms

Identification of:
Fusidic acid (HPLC) Positive Conforms
Fusidic acid (TLC) Positive * Conforms
Potassium sorbate Positive Conforms
Butylhydroxyanisole Positive * Conforms
Assay of:
Fusidic acid anhydrous 19,0 to 21,0 mg/g 20,2
Potassium sorbate 2,43 - 2,97 mg/g 2,67
Butylhydroxyanisole 32 - 44 mcg/g 38
Organic impurities of fusidic acid:
Total <= 2,0 % 0,3
3-Keto Fusidic acid (VD 524) <= 0,7 % 0,1
16-Epi-deacetyl fusidic acid (WG 551) <= 0,3 % 0,1
16-Deacetyl fusidic acid 16,21-lactone <= 0,3 % 0,1
(WG554)
Unspecified single impurity <= 0,2 % 0,1
Acidity: pH 4,5 - 6,0 5,1
Particle size >= 90 % <= 10um Conforms
Microbiological quality Ph.Eur.5.1.4 Conforms
Preparations for cutaneous use.

Comments: * Test applies at release.

(CYC):Test for named micro-organisms (Ph.Eur 2.6.13) is performed on
one batch every six months. (Release only)

It is hereby certified that the above information is authentic and accurate.

This batch of product has been manufactured, including packaging and quality control
at the above mentioned site in full compliance with GMP requirements of the local
Regulatory Authority and with the specifications in the Marketing Authorisation of the
importing country. The batch processing, packaging and analysis records were reviewed
and found to be in compliance with GMP.

27/NOV/2018 Released by electronic signature. page 1 of 1