Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Batch No. | FLZ210320 | Quantity | 50kgs |
Mfg. Date | Mar. 20, 2021 | Package | As required |
Rep. Date | Mar. 24, 2021 | Exp. Date | Apr. 19, 2023 |
Items | Standards | Results | |
Appearance | White or off-white powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Specific Optical Rotation | -105.0°~-110.0° | -107.6° | |
Water Content | ≤ 2.00% | 0.60% | |
Heavy Metals | ≤ 20ppm | Complies | |
Residual on Ignition | ≤ 0.10% | 0.06% | |
Residual Solvents | Acetonitrile ≤410ppm | ND | |
Acetone ≤5000ppm | 615ppm | ||
Methanol ≤3000ppm | ND | ||
Dichloromethane ≤600ppm | ND | ||
n-Heptane ≤5000ppm | 1271ppm | ||
Related Substances | Impurity A: ≤0.50% | ND | |
Impurity D: ≤0.50% | 0.24% | ||
Impurity C: ≤0.15% | ND | ||
Impurity D: ≤0.50% | 0.15% | ||
Each of Unspecified impurity: ≤0.10% | 0.04% | ||
Total Impurities: ≤1.00% | 0.44% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.20% | |
Microbial Limit | Total Aerobic: ≤100cfu/g | <10cfu/g | |
Total Yeasts and Molds: ≤100cfu/g | <10cfu/g | ||
Staphylococcus Aureus: Absent | Absent | ||
Pseudomonas Aeruginosa: Absent | Absent | ||
PSD | D50: ≤ 40µm | 12.65µm | |
D90: ≤ 100µm | 42.80µm | ||
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place,at temperature 2ºC~8ºC |