COA 质检单预览
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宁波英诺泰科生物科技有限公司
Ningbo Inopha Biotec Ltd.
质检单 CERTIFICATE OF ANALYSIS
| 产品名称 Product name | L-胱氨酸 L-Cystine | ||
| 生产日期/ Manufacturing date | 2025.08.14 | CAS No. | 56-89-3 |
| 报告日期/ Reporting date | 2026.03.05 | 批号/ Batch No. | C605-202508901 |
| 有效期/ Expiry date | 2027.08.13 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 外观 Appearance | 白色或类白色结晶性粉末 A white or almost white, crystalline powder | 符合 conforms |
| 鉴别 Identification | Test A: 比旋度(见检查) Specific optical rotation (see Tests); Test B: 红外吸收 Infrared absorption | 符合 conforms |
| 比旋度[α]D20 (EP) Specific optical rotation [α]D20 (EP) | -218° ~ -224° | -223° |
| 比旋度[α]D25 (USP) Specific optical rotation [α]D25 (USP) | -215° ~ -225° | -222° |
| 溶液外观 Appearance of solution | 澄清，颜色不深于Y7标准液 Clear and not more intensely coloured than reference solution Y7 | 符合 Conforms |
| 茚三酮阳性物质 Ninhydrin-positive substances | ≤ 0.2% | 符合 Conforms |
| 氯化物 Chloride | ≤ 200ppm | <200ppm |
| 硫酸盐 Sulfates | ≤ 200ppm | <200ppm |
| 铵盐 Ammonium | ≤ 200ppm | <200ppm |
| 铁 Iron | ≤ 10ppm | <10ppm |
| 重金属 Heavy metals | ≤ 10ppm | <10ppm |
| 干燥失重(EP) Loss on Drying (EP) | ≤ 0.2% | 0.12% |
| 干燥失重(USP) Loss on Drying (USP) | ≤ 0.2% | 0.12% |
| 硫酸灰分 Sulfated ash | ≤ 0.1% | <0.1% |
| 含量 Assay | 98.5 ~ 101.0 % (以干燥品计 on dried basis) | 99.5% |
| 微生物检查-需氧菌总数 Total aerobic microbial count | ≤100 CFU/g | <100 CFU/g |
| 内毒素 Endotoxin | < 0.02EU/mg | <0.02EU/mg |
| 检测结论/ Conclusion | 符合EP8、USP44标准 Agree with the specification of EP8,USP44. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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