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[PDF File]Drug name: Sildenafil Dosage Form: Concentration: Shelf ...
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Sildenafil citrate is a white to off-white crystalline powder with a solubility profile dependent on pH. ... The specification limit for total degradation products (shelf life) is 0.2% maximum. The microbiological quality is controlled in accordance with Ph. Eur., but is proposed as a non-routine
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[PDF File]CHMP ASSESSMENT REPORT FOR Sildenafil TEVA
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Public Assessment Report Scientific discussion Sildenafil CF 20 mg, film-coated tablets (sildenafil citrate) ... proposed shelf-life of five years, without any special temperature storage condition, is acceptable. ... Sildenafil citrate is a well-known active substance with established efficacy and tolerability.
shelf life of sildenafil

[PDF File]Public Assessment Report Scientific discussion Sildenafil ...
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Sildenafil suspension 2 mg/mL (50 mL) Patient’s name Storage condition In a refrigerator At room temperature NHI Temperature 2-8oC ≤ 25oC Date compounded Shelf life 30 days 30 days Batch number Recommended storage May be stored at room temperature if this is more practical and temperatures greater than 25oC are avoided
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[PDF File]SCIENTIFIC DISCUSSION please refer to module 8B.
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mg of Sildenafil citrate were manufactured by the Pharmaceutical Company Hi-Pharm, Batch 0360909 (Egypt) and Pfizer, Batch 9801 (USA), respectively, within their shelf life period. Sildenafil citrate reference substance (Batch SC06/005/05) was purchased from …
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[PDF File]Reversed Phase High Performance Liquid Chromatographic ...
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CHMP ASSESSMENT REPORT FOR Sildenafil TEVA International Nonproprietary Name: sildenafil ... Sildenafil citrate is a white to off-white, crystalline powder. Sildenafil citrate has the chemical name ... The results support the shelf life and storage conditions as defined in the SPC.
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Sildenafil Citrate Shelf Life | Best Prices | Excellent Quality
Drug name: Sildenafil . Dosage Form: Suspension . Concentration: 2.5 mg/mL . Shelf Life: 91 days : Route: Oral . Storage: Room temperature or refrigerate . Volume: 120 mL : Auxiliary Labeling: shake well before use . Ingredients QS Quantity Units Sildenafil 100-mg tablets . 3 . tablet . Ora-Sweet/Ora-Plus* Y qs ad 120 mL . Directions: 1 ...
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Sildenafil citrate shelf life