September 2016 SPDS Book

Ginger Monographs in USP39-NF34, 2016 Ginger Identification: Turbidity with ammonium oxalate, blue color with vanillin and sulfuric acid, HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols and Gingerdiones against capsaicin (NLT 0.8%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Macroscopy, Microscopy, Limit of Shogaols (NMT 0.18%), Alcohol-Soluble Extractives (NLT 4.5%), Starch (NLT Powdered Ginger Identification: Turbidity with ammonium oxalate, blue with vanillin and sulfuric acid, HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols and Gingerdiones against capsaicin (NLT 0.8%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Microscopy, Limit of Shogaols (NMT 0.18%), Alcohol-Soluble Extractives (NLT 4.5%), Starch content (NLT 42%), Total Ash (NMT 8.0%), Acid-Insoluble Ash (NMT 2.0%), Water-Soluble Ash (NLT 1.9%), Volatile Oil (NLT 1.8 mL/100g), Water-Soluble Extractives (NLT 10.0%), Water (NMT 10%) Ginger Capsules Id tifi ti T bidit ith i l t bl ith illi d lf i id HPTLC i t [6] i l d [6] h l en ca on: ur y w ammon um oxa a e, ue w van n an su ur c ac , aga ns -g ngero an -s ogao Strength: Content of Gingerols, Gingerdiones and Shogaols against capsaicin (90.0–110.0%), Volatile Oil (NLT 1.4 mL/100g) Performance: Dissolution (NLT 60% of [6]-gingerol), Weight Variation 42%) Foreign Organic Matter (NMT 1 0%) Total Ash (NMT 8 0%) Acid Insoluble Ash (NMT 2 0%) Water Soluble , . , . , - . , - Ash (NLT 1.9%), Volatile Oil (NLT 1.8 mL/100g), Water-Soluble Extractives (NLT 10.0%), Water (NMT 10%)

Ginger Tincture

Identification: HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols against capsaicin (NLT 0.10%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Limit of Shogaols (NMT 0.034%), Limit of Nonvolatile Residue (NMT 0.5%), Specific Gravity (0.90 – 0.95)

Ginger Monographs in USP39-NF34, 2016