Certificate of Analysis: Method Specifications Results Test

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FAGRON IBERICA, S.A.U.

· JOSEP TAPIOLAS,150 · ES-08226 TERRASSA · BARCELONA


Tel 937310722
Fax 937311644
www.fagron.es www.compoundingmatters.com

Pg. 1
20. September 2017

Certificate of Analysis
BUTYLHIDROXYANISOLE

PM 180,30 Expiry date 28/10/16


Nº CAS 25013-16-5 Nº Análisis / Analysis Nº BA-31444
Item Number 30347-00 Nº Lote/ Batch No L15050152
Conclusion date 20/11/15 Nº Análisis / Analysis Nº M-041341
Manuf. Vendor No. Quality PH.EUR.
Nº Lote Fab. ABH014K046

INCI BHA
Characters White, yellowish or slightly pinkish, crystalline powder or crystalls. Practically insoluble in water, very soluble un
methylene chloride, freely soluble in alcohol and in fatty oils. It dissolves in dilute solutions of alkali hydroxides.

TEST SPECIFICATIONS RESULTS METHOD

Identification A# B# C Conforme A0130347-00


Appearance of solution Límpida y no más coloreada que grado 5 Conforme A0230347-00
Related substances Test Ph.Eur. Conforme A0730347-00
Assay < 10 % (3-(1,1-dimetiletil-4-metoxifenol) < 10 % A1030347-00
Melting range 48 - 63 ºC 52,8 - 60,3 ºC A1130347-00
Heavy metals < 10 ppm < 10 ppm A1230347-00
Sulphated ash < 0.1 % 0,0039 % A1330347-00

Storage In a well-closed container, protected from light

Anna Viñas
Directora Técnica Farmacéutica

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