Research Article
Biocurcumin as Radiosensitiser for Cervical Cancer Study (BRACES): A Double-Blind Randomised Placebo-Controlled Trial
Table 1
Analysis of BCM-95’s components
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| Description | Specification | Test method | Results |
| Identification | Pass | TLC | Complies | Color | Orange red | Visual | Complies | Appearance | Powder | Visual | Complies | Flavor | Characteristic | Organoleptic | Complies | Odor | Characteristic | Organoleptic | Complies |
| Analytical assay | | | | Herb exact ratio | 25 : 1 | In-house specification | Complies | Solubility (in acetone) (in water | Soluble Insoluble | IP IP | Complies Complies | Moisture | NMT 2% | USP <921> | 0.2% | Extraction solvent | 100% ethyl acetate | In-house specification | Complies | Particle size | 100% through 30 mesh | USP <786> | Complies | Allergens | None detected | Elisa | Complies | Tap density (g/ml) | NLT 0.60 | USP <616> | 0.82 | Bulk density (g/ml) | NLT 0.39 | USP <616> | 0.61 | Pesticide residue | Complies with USP | USP <561> | Complies | Excipients | None | In-house specification | Complies | Carriers | None | In-house specification | Complies |
| Residual solvents | | | | Benzene | As per USP | USP <467> | Complies | Carbon tetrachloride | As per USP | USP <467> | Complies | 1,2-Dichloroethane | As per USP | USP <467> | Complies | 1,1-Dichloroethane | As per USP | USP <467> | Complies | 1,1,1-Trichloroethane | As per USP | USP <467> | Complies | Ethyl acetate | As per USP | USP <467> | Complies | Ethanol | As per USP | USP <467> | Complies | Acetone | As per USP | USP <467> | Complies |
| Trace metals | | | | Total heavy metals | NMT 10 ppm | ICP-MS | 0.3911 ppm | Arsenic | NMT 1 ppm | ICP-MS | 0.0183 ppm | Lead | NMT 0.5 ppm | ICP-MS | 0.3728 ppm | Mercury | NMT 1 ppm | ICP-MS | BDL | (BDL: As, 0.02 ppb; Pb, 0.015 ppb; Hg, 0.02 ppb) | | | |
| Microbiological assay | | | | Total plate count | NMT 1,000 cfu/g | AOAC, BAM | 20 cfu/g | Yeast and mold | NMT 100 cfu/g | AOAC, BAM | 10 cfu/g | Salmonella | Absent/25 g | AOAC, BAM | Complies | E. coli | Absent/10 g | AOAC, BAM | Complies | Staphylococcus aureus | Absent/10 g | AOAC, BAM | Complies | Pseudomonas aeruginosa | Absent/10 g | AOAC, BAM | Complies | Aflatoxin | Absent | AOAC, BAM | Complies | Coliforms | Absent/10 g | AOAC, BAM | Complies | (Microbial assay detection limit: 10 cfu/g) | | | |
| Assay for actives | | | | Volatile compounds of turmeric | Present | UV-Vis | Complies | Total curcuminoids complex | NLT 95% | HPLC | 98.39% |
| Consisting of curcumin, desmethoxy curcumin, bis-desmethoxy curcumin, and volatile oils of turmeric rhizome | | | | Total curcuminoids | NLT 86% | HPLC | 91.39% | Curcumin | NLT 65% | HPLC | 71.96% |
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