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Specification: Enterprise standards
Appearance: White or off-white powder.
Specific rotation: +15.0o~+19.0o
Chloride: ≤0.2%
Sulphate: ≤0.05%
Water content: ≤4.0%
Fluorine: 3.5%~4.0%
Calcium: 3.8%~4.2%
Heavy metal: ≤20ppm
Single biggest unknown impurity: ≤0.5%
Total impurities: ≤1.5%
Enantiomer: ≤0.5%
Assay: 98.0~102.0%
Residual solvent:
Methanol: ≤3000ppm
Tetrahydrofuran: ≤720 ppm
Specification: Enterprise standards
Appearance: White or off-white powder.
Specific rotation: +15.0o~+19.0o
Chloride: ≤0.2%
Sulphate: ≤0.05%
Water content: ≤4.0%
Fluorine: 3.5%~4.0%
Calcium: 3.8%~4.2%
Heavy metal: ≤20ppm
Single biggest unknown impurity: ≤0.5%
Total impurities: ≤1.5%
Enantiomer: ≤0.5%
Assay: 98.0~102.0%
Residual solvent:
Methanol: ≤3000ppm
Tetrahydrofuran: ≤720 ppm
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