| ≥1 piece |
| analysis items | specifications | results | methods used | ||||
| identification | positive | conforms | tlc | ||||
| appearance | white crystal | conforms | visual test | ||||
| odor & taste | characteristic | conforms | organoleptic test | ||||
| solubility | soluble in acetone, methanol and chloroform | conforms | visual | ||||
| assay | capsaicinoids nlt 95% | 95.80% | hplc usp32 | ||||
| capsaicin nlt 55% | 61.69% | hplc usp32 | |||||
| total content of capsaicin and dihydrocapsaicin nlt 75% | 93.29% | hplc usp32 | |||||
| total content of other capsaicins nmt 15% | 2.61% | hplc usp32 | |||||
| melting range | 57 － 66 ℃ | 60-64 ℃ | / | ||||
| loss on drying | nmt 1.0% | 0.22% | 5g /105 ℃ /2hrs | ||||
| ignition residue | nmt 1.0% | 0.15% | 2g /525 ℃ /3hrs | ||||
| extract solvents | ethanol & water | conforms | / | ||||
| solvent residues | nmt 0.01% | conforms | usp-gc | ||||
| excipients | none | conforms | / | ||||
| heavy metals | nmt 10ppm | conforms | atomic absorption | ||||
| arsenic (as) | nmt 0.5ppm | conforms | atomic absorption | ||||
| lead (pb) | nmt 1ppm | conforms | atomic absorption | ||||
| cadmium (cd) | nmt 0.5ppm | conforms | atomic absorption | ||||
| mercury(hg) | nmt 0.2ppm | conforms | atomic absorption | ||||
| bhc | nmt 0.1ppm | conforms | usp-gc | ||||
| ddt | nmt 0.1ppm | conforms | usp-gc | ||||
| acephate | nmt 0.2ppm | conforms | usp-gc | ||||
| pcnb | nmt 0.1ppm | conforms | usp-gc | ||||
| aflatoxins | nmt 0.2ppb | absent | usp-hplc | ||||
| sterilization method | high temperature & pressure for a short time of 5 ～ 10 seconds | ||||||
| microbiological data | total plate count < 1000cfu/g | < 100 cfu/g | gb 4789.2 | ||||
| total yeast & mold < 100cfu/g | < 30 cfu/g | gb 4789.15 | |||||
| e. coli to be absent | absent | gb 4789.3 | |||||
| staphylococcus to be absent | absent | gb 4789.4 | |||||
| salmonella to be absent | absent | gb 4789.10 | |||||
| packing and storage | packed in fiber drum, ldpe bag inside. net weight: 25kgs/drum. | ||||||
| keep tightly sealed, store away from moisture, strong heat and sunlight. | |||||||
| shelf life | 2 years if sealed and stored in the recommended conditions. | ||||||
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