组分信息
| CAS号 | 名称 | 标准值 | 单位 |
|---|---|---|---|
| 831217-01-7 | 红地那非 | 100 | μg/mL |
| 949091-38-7 | 那红地那非 | 100 | μg/mL |
| 224788-34-5 | 伪伐地那非 | 100 | μg/mL |
| 330808-88-3 | 盐酸伐地那非三水合物 | 100 | μg/mL |
| 139755-83-2 | 西地那非 | 100 | μg/mL |
| 371959-09-0 | 那莫西地那非 | 100 | μg/mL |
| 171596-29-5 | 他达拉非 | 100 | μg/mL |
| 385769-84-6 | 氨基他达那非 | 100 | μg/mL |
| 642928-07-2 | 豪莫西地那非 | 100 | μg/mL |
| 139755-85-4 | 羟基豪莫西地那非 | 100 | μg/mL |
| 856190-47-1 | 硫代艾地那非 | 100 | μg/mL |
详细介绍
11种补肾壮阳类药物混标/11种那非类混标/2022国抽保健品/药品检验补充方法2009030/2023国抽保健品
This certificate is designed in accordance with ISO 17034 and ISO Guide 31. This reference material (RM) was designed,produced and verified in accordance with ISO/IEC 17025, ISO 17034 and a registered quality management system ISO 9001.
冷冻(-18±5)℃,置于阴凉处
| CERTIFIED | |||||
|
Component No. (组分数) |
Concentration (μg/mL) (浓度) |
Relative Expanded Uncertainty(%) (k=2) (相对扩展不确定度) |
|||
| 1 | 1 | Vardenafil Hydrochloride Trihydrate (盐酸伐地那非三水合物) | 330808-88-3 | 100(free base) | 3 |
| 2 | 2 | Nor Acetildenafil (那红地那非) | 949091-38-7 | 100 | 3 |
| 3 | 3 | Acetildenafil (红地那非) | 831217-01-7 | 100 | 3 |
| 4 | 4 | Hydroxyhomosildenafil (羟基豪莫西地那非) | 139755-85-4 | 100 | 3 |
| 5 | 5 | Sildenafil (西地那非) | 139755-83-2 | 100 | 3 |
| 6 | 6 | Homo Sildenafil (豪莫西地那非) | 642928-07-2 | 100 | 3 |
| 7 | 7 | Amino Tadalafil (氨基他达那非) | 385769-84-6 | 100 | 3 |
| 8 | 8 | Tadalafil (他达拉非) | 171596-29-5 | 100 | 3 |
| 9 | 9 | Pseudo Vardenafil (伪伐地那非) | 224788-34-5 | 100 | 3 |
| 10 | 10 | Thioaildenafil (硫代艾地那非) | 856190-47-1 | 100 | 3 |
| 11 | 11 | Norneosildenafil (那莫西地那非) | 371959-09-0 | 100 | 3 |
This RM is intended for use in a laboratory as a calibration and quality control standard or in method development for analytical techniques.
The certified value(s) and uncertainty(ies) are determined in accordance with ISO 17034 with an 95% confidence level (k=2). Uncertainty is based on the Total Combined Uncertainty, including uncertainties of preparation, purity of neat materials, homogeneity, stability testing.
The balances used for gravimetric measurements are calibrated with weights traceable to the national standards. The calibration of the balances is verified annually by an external accredited calibration service. This analysis method has been verified using an approach consistent with ISO 17034:2016 & ISO 17025:2017.
Random replicate samples of the final packaged RM have been analysed to prove homogeneity consistent with ISO 17034.
The RM should be stored in the original sealed bottle at the indicated temperature.
| CERTIFICATE ON | QC SIGNATURE | |
| 2023-Jan-05 |
|
RM Release |
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