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Sinoway Industrial Co.Ltd.
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Product name
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Lenalidomide
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CAS No.
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191732-72-6
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Molecular Formula
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C13H13N3O3
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Molecular Weight
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259.26062
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Quality Standard
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98% up, Medicine Grade
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Appearance
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White to light yellow crystalline powder
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Test Items
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Specifications
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Results
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Appearance
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White to light yellow crystalline powder
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conforms
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Water content
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≤ 4.0%
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0.021
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Residuce on ignition
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≤ 0.5%
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0.0032
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Residual Solvents
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Methanol≤ 3000ppm
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1400ppm
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Acetonitrile≤ 410ppm
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not detected
|
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Carbon tetrachloride≤ 4ppm
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not detected
|
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Tetrahydrofuran≤ 720ppm
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250ppm
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Dimethylformamide
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320ppm
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≤ 550ppm
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Related Substance
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Single Impurity≤1%
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0.004
|
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Total Impurity≤1.5%
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0.008
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Assay
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≥98.0%
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0.996
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Test Items
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Specifications
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Results
|
Appearance
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White to light yellow crystalline powder
|
conforms
|
Water content
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≤ 4.0%
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0.021
|
Residuce on ignition
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≤ 0.5%
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0.0032
|
Residual Solvents
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Methanol≤ 3000ppm
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1400ppm
|
|
Acetonitrile≤ 410ppm
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not detected
|
|
Carbon tetrachloride≤ 4ppm
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not detected
|
|
Tetrahydrofuran≤ 720ppm
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250ppm
|
|
Dimethylformamide
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320ppm
|
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≤ 550ppm
|
|
Related Substance
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Single Impurity≤1%
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0.004
|
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Total Impurity≤1.5%
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0.008
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Assay
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≥98.0%
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99.6%
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Function of Lenalidomide
1. Lenalidomide API is an anti-tumor drug developed by Celgene biopharmaceutical company. The chemical structure is similar to thalidomide, which has multiple functions such as anti-tumor, immune regulation and anti-angiogenesis.
2. Lenalidomide inhibits the secretion of proinflammatory cytokines and increases the secretion of anti-inflammatory cytokines in peripheral blood monocytes.
3. Lenalidomide can also inhibit the expression of cyclooxygenase 2(cox-2), but it has no effect on cox-1.
4. Lenalidomide besides can be used to treat MDS and MM, for multiple myeloma, leukemia, metastatic renal cell carcinoma, solid tumor, idiopathic generalized the degeneration amylum and with marrow unripe systemic bone marrow fibrosis disease have certain curative effect.
5. Lenalidomide is currently the most effective drug to treat multiple myeloma. |
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ZHEJIANG SACHEM PHARMACEUTICAL TECHNOLOGY CO.,LTD.
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Since its establishment, Zhejiang Saikai Pharmaceutical Technology Co., Ltd. has continuously enhanced its resource integration ability around the pharmaceutical industry chain, built an enterprise-oriented and market-oriented business system, actively identified the key links of the upstream and downstream of the industrial chain, and promoted the overall improvement of the supply chain.
The company has always been committed to opening the international market for small and medium-sized production enterprises. Through the efforts of professional international business team, the company has helped steroid hormone apis and intermediates gain a certain market voice in India. Based on the existing achievements, the company insists on expanding the product line, and has established cooperative relations with many manufacturers in Zhejiang, Hunan, Jiangsu and other provinces. In addition to India, the products are exported to Europe, South America and other overseas regions, and a broad sales market has been established.
Since 2025, relying on the head office to carry out API import, registration and agent procurement business. Under the cooperation of the total company registration team, the company successfully completed the introduction and registration of a number of high-quality apis, and established product cooperation with foreign first-line enterprises, and successfully helped the parent company and domestic pharmaceutical customers related review.
In the future, Sikai Pharmaceutical will forge ahead, do not slack, focus on improving the level of business, to create an excellent corporate brand image. We will make full use of our own advantages, continue to integrate domestic and foreign resources, through strategic cooperation to reach a strong alliance between enterprises, to achieve mutual benefit, mutual assistance and win-win. |
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Pharma Sources Insight June 2024: Globalization on the Go
