Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Item |
Standard |
Appearance |
White crystal powder |
Melting Point |
102--109°C |
Loss on drying |
<1.0% |
Known single impurity |
<1.0% |
Unknown single impurity
|
<0.5% |
Total impurity
|
<2.0% |
Assay(as dried) |
99% |
Pirfenidone is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.
The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Pirfenidone is not a cure for IPF, but this medicine may slow the progress of this disease.
Pirfenidone may also be used for purposes not listed in this medication guide.
Pirfenidone can inhibit the uterine flesh tumour cells and leiomyoma cells proliferation. Pirfenidone can inhibit the TGF - beta - 1 inducing fibroblast collagen formation. Inhibition of PDGF, FGF and TGF - beta - 1 inducing fibroblast proliferation. In hamster model, pirfenidone, taken by mouth, that can the prevention and treatment of pulmonary fibrosis induced by bleomycin. Pirfenidone can prevent the sclerosing peritonitis in rats induced by chemical, can also be keloid grafting for the treatment of nude mice. Pirfenidone 0.01 1 mg/ml can suppress the matrix and dose dependent manner serum stimulate uterine fibroids and leiomyoma cell DNA synthesis, the compound has no cytotoxic effect, has no effect on collagen mRNA level also. Pirfenidone in hamster pulmonary fibrosis model can reduce the disease before the collagen I mRNA level enhancement,reduce the level of the lung hydroxyproline and malondialadehyde and lung preserved ammonia acyl hydroxylase activity.
In vitro, pirfenidone can inhibit the uterine flesh tumour cells and leiomyoma cells proliferation. Pirfenidone can inhibit the TGF - beta - 1 inducing fibroblast collagen formation. Inhibition of PDGF, FGF and TGF - beta - 1 inducing fibroblast proliferation. In hamster model, pirfenidone, taken by mouth, that can the prevention and treatment of pulmonary fibrosis induced by bleomycin. Pirfenidone can prevent the sclerosing peritonitis in rats induced by chemical, can also be keloid grafting for the treatment of nude mice. Pirfenidone 0.01 1 mg/ml can suppress the matrix and dose dependent manner serum stimulate uterine fibroids and leiomyoma cell DNA synthesis, the compound has no cytotoxic effect, has no effect on collagen mRNA level also. Pirfenidone in hamster pulmonary fibrosis model can reduce the disease before the collagen I mRNA level enhancement, reduce the level of the lung hydroxyproline and malondialadehyde and lung preserved ammonia acyl hydroxylase activity.
Product Name | Lopinavir | ||
Batch Number | Z20180901 | ||
Production Date | 2018.9. 3 | ||
Batch Quantity | 24000G | ||
Analysis Date | 2018.9. 4 | ||
Expiry Date | 2020.9. 2 | ||
Certificate Date | 2018.9. 15 | ||
Item | Test Standard | Testing Result | |
CBD | Not less than (NLT) 99.5% 99.9% | ||
THC | Not detected | Undetected | |
Assay | Method HPLC calculated on the anhydrous basis limit of quotation (LOQ) 0.8ppm | ||
Appearance | White powder | White powder | |
Identification | In the recorded chromatograms under the determination of the substance, retention time of the main peak of the solution should be consistent with the retention of time of the main peak of the reference solution | Complies | |
Melting Point | 65~66ºC | 65.5ºC | |
Loss on Drying | NMT 1.0% | 0.21% | |
Residual solvents | Ethanol NMT 400ppm Heptane NMT 400ppm |
1.92ppm 256.0ppm |
|
Heavy Mental | NMT 20ppm | Complies | |
Microbial Limite Test | Method: Plate Counting | ||
Total aerobic bacteria count | NMT 1000cfu/g | Complies | |
Combined molds and yeast | NMT 100cfu/g | Complies | |
E. Coli | Not detacted per gram | Complies | |
Salmanella | Not detacted per 10 gram | Complies | |
Conclusion: Conform the testing result is qualified |
Storage: Closed container. Dry & cool. Keep away from moisture &strong light
Shelf life: 24 Months
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