Temozolomide Powder was synthesized by Cancer Research UK and then transferred to Schering plow company in the United States for development. Different from the existing anti-tumor drugs, the drug has a novel chemical structure, belongs to imidazole tetrazine derivatives, belongs to the second generation alkylating agent with anti-tumor activity, and does not need intrahepatic metabolic activation after oral administration. It is characterized by easy penetration of the blood-brain barrier, good tolerance, and no superimposed toxicity with other drugs. It has a synergistic effect with radiotherapy. It is suitable for malignant gliomas that relapse after routine treatment, such as glioblastoma multiforme or degenerative astrocytoma. It is also the first-line drug for the treatment of metastatic melanoma.
| structural formula |
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ITEMS |
SPECIFICATIONS |
RESULTS |
|
Appearance |
White to light brown powder |
Complies |
|
Odor & Tasted |
Characteristic |
Complies |
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Temozolomide Assay( %) |
≥ 99.0 HPLC |
99.89 |
|
Loss on Drying(%) |
≤2.0 |
0.80 |
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Ash(%) |
≤2.0 |
0.20 |
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Particle size(%) |
100% through 80 mesh sieves |
Complies |
|
Heavy Metal(ppm) |
≤10 |
1.1 |
|
Pb(ppm) |
≤2.0 |
0.01 |
|
As(ppm) |
≤2.0 |
0.2 |
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Pesticides Residues (ppm) |
≤1.0 |
0.1 |
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Solvents Residue (ppm) |
≤1.0 |
0.8 |
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Extraction Solvent |
Ethanol&water |
Complies |
|
Total Plate Count(cfu/g) |
≤ 1000 |
12 |
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Yeasts and Moulds(cfu/g) |
≤ 100 |
0.2 |
|
E.coli(cfu/g) |
- |
Negative |
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Salmonella |
- |
Negative |
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Staphylococcus |
- |
Negative |
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Conclusion： |
Conform with enterprise specification . |
What is the therapeutic effect of this product on recurrent pleomorphic glioblastoma?
Temozolomide Powder is safe and effective in the treatment of recurrent pleomorphic glioblastoma. The results of the phase II randomized controlled trial showed that 225 patients with pleomorphic glioblastoma relapsed for the Treatment with temozolomide for the first time or procarbazine (for 28 days every 56 days, oral administration of 125 ~ 150mg / m2 every day) for 6 months respectively. There was no progress in the temozolomide group. The survival rate and overall survival rate were 21% and 60%, respectively, which were significantly higher than 8% and 44% in the procarbazine group. The mean progression-free survival time and total survival time of temozolomide patients were 2.9 and 7.3 months, respectively, which were also significantly higher than 1.9 and 5.8 months in the procarbazine group. The trial also assessed the health-related quality of life at the 3rd and 6th months after the start of treatment. The results also confirmed that the quality of life of more patients in the temozolomide group improved or remained stable. The main adverse reaction of temozolomide was transient and noncumulative bone marrow suppression, which was predictable and easy to deal with. The incidence in the trial was 24%. Temozolomide is also prone to mild to moderate nausea and vomiting, but it can be prevented by conventional antiemetic therapy. Temozolomide is superior to the existing standard drug procarbazine in the efficacy and adverse drug reactions of recurrent pleomorphic glioblastoma.
Clinical trial evaluation of first-line treatment of melanoma
As mentioned above, although the effect on newly diagnosed and degenerative astrocytoma is not clear. However, the role of temozolomide in the first-line treatment of progressive metastatic melanoma has also been affirmed by clinical trials, which is another important event worthy of attention, and relevant personnel has applied for application in Europe, the United States, and other countries. The results of a recently published phase III randomized controlled trial showed that after 305 patients were treated with temozolomide (200mg / m2) and dacarbazine (250mg / m2 every 21 days for 5 days), the total survival time and treatment response rate of patients in Temozolomide group was 7.9 months and 13.5% respectively, which were better than 5.7 months and 12.1% in the dacarbazine group. The tolerance of the temozolomide group was better than that of the dacarbazine group, and the assessment of the quality of life based on the reduction of physiological function was also significantly better than that of the dacarbazine group (the decline rates after 3 months of treatment were 18% and 42%, respectively). Melanoma is a rare skin tumor. Although it accounts for only about 4% of all skin cancers, its mortality accounts for about 79% of all skin cancers, and dacarbazine is the standard drug currently used. Temozolomide powder has shown quite high clinical efficacy for refractory glioma and melanoma. It is believed that temozolomide is the best alternative therapy in the future.
About the market situation of this product
It is believed that the cytotoxicity of music is mainly due to its DNA alkylation (methylation), which mainly occurs at the O6 and N7 positions of guanine. Temozolomide Powder has been proved to be effective for some of the most common gliomas through basic and clinical studies. It is more effective than ordinary products for malignant gliomas, such as glioblastoma multiforme or degenerative astrocytoma. It is also a first-line product for the treatment of metastatic melanoma. It was approved by the European Union and the United States in 1999, Among them, the approved indications in the United States are the second-line treatment of gliomas such as pleomorphic glioblastoma and degenerative astrocytoma, and the approved indications in EU countries are pleomorphic glioblastoma with development or recurrence after routine treatment. The effect of temozolomide on pleomorphic glioblastoma has been more recognized in Europe.
A variety of shipping methods for you to choose
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Transportation Time |
Shipping method |
Cargo weight requirements |
Advantage |
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3-7 days |
DHL,Germany DHL,Germany DPD, |
Suitable for under 50kg. |
We have warehouses in Germany and California, USA, |
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7-15 days |
By Air |
Suitable for more than 50kg. |
|
|
15-60 days |
By Sea |
Suitable for more than 500kg. |
Our strengths:
Our company has passed FDA and ISO19001 quality management system certification. And we have internal cooperation agreements with multiple factories and laboratories in China,Our company can provide Temozolomide Powder etc. at a more favorable price. If you are interested, please leave a message.
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