A&C AMERICAN CHEMICALS LTD. 3010 Rue De Baene, Montréal Quebec, Canada, H4S 1L2 Telephone: 18003619234 www.acggp.com
SPECIFICATION SHEET / FEUILLE DE SPÉCIFICATIONS
COD LIVER OIL USP (1000A/100D) Catalogue Code: C34347 Formula Formula Weight: N/A CAS Number: 8001-69-2 TEST METHOD SPECIFICATION Assay Vitamin A USP-NF <571> 300 750 µg/g Procedure 1 Vitamin D USP-NF <581> 2.5 6.25 µg/g Procedure 8 Identification A) Vitamin A USP-NF Blue Color B) Fatty Acid Profile USP-NF <621> Saturated Fatty Acids Myristic acid (C14:0) 2.0-6.0 Area% Palmitic acid (C16:0) 7.0-14.0 Area% Stearic acid (C18:0) 1.0-4.0 Area% Monounsaturated Fatty Acids Palmitoleic acid (C16:1,n-7) 4.5-11.5 Area% cis-Vaccenic acid (C18:1,n-7) 2.0-7.0 Area% Oleic acid (C18:1,n-9) 12.0-21.0 Area% Gadoleic acid (C20:1,n-11) 1.0-5.5 Area% Gondoic acid (C20:1,n-9) 5.0-17.0 Area% Erucic acid (C22:1,n-9) 0-1.5 Area% Cetoleic acid (C22:1,n-11) 5.0-12.0 Area% Polyunsaturated Fatty Acids Linoleic acid (C18:2,n-6) 0.5-3.0 Area% a-Linolenic acid (C18:3,n-3) 0-2.0 Area% Moroctic acid (C18:4,n-3) 0.5-4.5 Area% Eicosapentaenoic acid (C20:5,n-3) 7.0-16.0 Area% Docosahexaenoic acid (C22;6,n-3) 6.0-18.0 Area% C) IR USP-NF To Conform Description Visual Thin Clear, Amber, Oily Liquid Specific Gravity USP-NF <841> 0.918 - 0.927 Color USP-NF To Conform Nondestearinated Cod Liver Oil USP-NF Clear with no Stearin Deposits Unsaponifiable Matter USP-NF <401> 1.30% Max. Acid Value (0.1N NaOH) USP-NF <401> 1.0 mL Max. Iodine Value USP-NF <401> 145 - 180 Saponification Value USP-NF <401> 180 - 192 Anisidine Value USP-NF <401> 30 Max. ResidualRevision: 7 Solvents USP-NF <467> Meets the Requirements Revision date: 2019/06/13 Released Page 1 / 2
Meets current USP-NF specifications
Preserve in tight containers. Packed under Nitrogen
Elemental Impurities Information (USP <232>, Ph. Eur. 5.20, ICH Q3D) for this product is as follows: Class 1-3 elements are not likely to be present above the Option 1 limit (oral) of the ICH Q3D guidance
This product is manufactured and distributed in accordance with EXCiPACT, the Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices and Good Distribution Practices
Peter McGarry, Director, Quality Assurance
Verified and Approved by COD LIVER OIL USP (1000A/100D) Catalogue Code: C34347 Formula Formula Weight: N/A CAS Number: 8001-69-2 TEST METHOD SPECIFICATION Assay Vitamin A USP-NF <571> 300 750 µg/g Procedure 1 Vitamin D USP-NF <581> 2.5 6.25 µg/g Procedure 8 Identification A) Vitamin A USP-NF Blue Color B) Fatty Acid Profile USP-NF <621> Saturated Fatty Acids Myristic acid (C14:0) 2.0-6.0 Area% Palmitic acid (C16:0) 7.0-14.0 Area% Stearic acid (C18:0) 1.0-4.0 Area% Monounsaturated Fatty Acids Palmitoleic acid (C16:1,n-7) 4.5-11.5 Area% cis-Vaccenic acid (C18:1,n-7) 2.0-7.0 Area% Oleic acid (C18:1,n-9) 12.0-21.0 Area% Gadoleic acid (C20:1,n-11) 1.0-5.5 Area% Gondoic acid (C20:1,n-9) 5.0-17.0 Area% Erucic acid (C22:1,n-9) 0-1.5 Area% Cetoleic acid (C22:1,n-11) 5.0-12.0 Area% Polyunsaturated Fatty Acids Linoleic acid (C18:2,n-6) 0.5-3.0 Area% a-Linolenic acid (C18:3,n-3) 0-2.0 Area% Moroctic acid (C18:4,n-3) 0.5-4.5 Area% Eicosapentaenoic acid (C20:5,n-3) 7.0-16.0 Area% Docosahexaenoic acid (C22;6,n-3) 6.0-18.0 Area% C) IR USP-NF To Conform Description Visual ThinA&C AMERICAN CHEMICALS LTD. Clear, Amber, Oily Liquid Specific Gravity USP-NF <841> 0.918 - 0.9273010 Rue De Baene, Montréal Quebec, Canada, H4S 1L2 Color USP-NF To Conform Telephone: 18003619234 Nondestearinated Cod Liver Oil USP-NF Clear with no Stearin Depositswww.acggp.com Unsaponifiable Matter USP-NF <401> 1.30% Max. Acid Value (0.1N NaOH) USP-NF <401> 1.0 mL Max. Iodine Value SPECIFICATION SHEETUSP-NF <401>/ FEUILLE DE SPÉCIFICATIONS145 - 180 Saponification Value USP-NF <401> 180 - 192 Anisidine Value USP-NF <401> 30 Max. Residual Solvents USP-NF <467> Meets the Requirements
Meets current USP-NF specifications
Preserve in tight containers. Packed under Nitrogen
Elemental Impurities Information (USP <232>, Ph. Eur. 5.20, ICH Q3D) for this product is as follows: Class 1-3 elements are not likely to be present above the Option 1 limit (oral) of the ICH Q3D guidance
This product is manufactured and distributed in accordance with EXCiPACT, the Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices and Good Distribution Practices
Peter McGarry, Director, Quality Assurance
Verified and Approved by
Revision: 7 Revision date: 2019/06/13 Released Page 2 / 2