Taurine occurs as colorless or white crystals, or a white crystalline powder. It is soluble in water, and practically insoluble in ethanol (99.5%). The pH of a solution prepared by dissolving 1.0g of Taurine in 20mL of freshly boiled and cooled water is between 4.1 and 5.6.
Item | JP17 standard | USP41 standard | JP17 test method | USP41 test method |
Identification | Conforms | A. Conforms | IR (JP17 <2.25>) | IR (USP41 <197K>) |
B. Conforms | HPLC Retention time | |||
Clarity and color of solution | Clear and colorless | -------- | JP17 Page 1643 | ------ |
Chloride | Max 0.011% | Max 0.05% | JP17 <1.03> | USP41 <221> |
Sulfate | Max 0.010% | Max 0.03% | JP17 <1.14> | USP41 <221> |
Ammonium | Max 0.02% | -------- | JP17 <1.02> | -------- |
Heavy metals | NMT 10ppm | -------- | JP17 <1.07> | -------- |
Iron | NMT 10ppm | NMT 30ppm | JP17 <1.10> | USP41 <241> |
Related substances | Meet to requirement | Meet to requirement | TLC (JP17 <2.03>) | USP41 <621> |
Loss on drying | NMT 0.20% | NMT 0.3% | JP17 <2.41> | USP41 <731> |
Residue on ignition | NMT 0.1% | NMT 0.3% | JP17 <2.44> | USP41 <281> |
Assay(On dried basis) | 99.0%~101.0% | 98.0%~102.0% | Titrate (JP17 <2.50>) | HPLC (USP41) |
Microbiological | ||||
Item | Standard | Test Method | ||
Total plate count | NMT 1000cfu/g | CP2015: Addenda XI J | ||
Mold | NMT 100cfu/g | |||
Yeast | NMT 100cfu/g | |||
E. Coli | Negative/10g | |||
*Salmonella | Negative/25g | |||
*Staphylococcus aureus: | Negative/10g | |||
Heavy Metals | ||||
Item | Standard | Test Method | ||
*Lead | <0.5ppm | CP2015, GB or equivalent | ||
*Arsenic | <1ppm | |||
*Cadimium | <1ppm | |||
*Mercury | <0.1ppm |
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