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375815-87-5
Aluminum Foil Bag
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Product Description
Certificate of Analysis
Product Name: Varenicline tartrate
CAS: 375815-87-5
Product Name: Varenicline tartrate
CAS: 375815-87-5
| Batch No. | HF160822 | Quantity | 1240kgs |
| Mfg. Date | Aug. 22, 2016 | Package | As required |
| Rep. Date | Aug. 25, 2016 | Exp. Date | Aug. 21, 2018 |
| Items | Standards | Results | |
| Appearance | Red powder | Red | |
| Identification | By HPLC | Complies | |
| Melting Point | 120ºC~130ºC | 126ºC | |
| Loss on Drying | ≤1.00% | 0.21% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| Sulfated Ash | ≤ 0.10% | 0.03% | |
| Content | 17.5%~19.5% | 19.3% | |
| Content | ≤ 0.1ppm | 0.09ppm | |
| Lead VContent | ≤ 3.0ppm | 0.50ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Microbiological Test | Coliforms:Negative | Negative | |
| Salmonella: Negative | Complies | ||
| Total plate count: ≤1000 CFU/g | Pass | ||
| Yeast&Mold: ≤50 CFU/g | Pass | ||
| Related Substances | Impurity A: ≤0.30% | 0.18% | |
| Other unknown impurity: ≤0.10% | 0.07% | ||
| Total Impurities: ≤0.50% | 0.42% | ||
| Assay | ≥ 98.0% | 99.50% | |
| Reference Standard | USP Standard | ||
| Conclusion | The product complied to USP standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
