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- W1511247418 abstract "D-003 is a new under research drug with potential use for preventing or treating atherothrombotic diseases. This product is made up of a mixture of very high molecular weight aliphatic acids (C24:0 to C36:0) purified from sugar cane (Sac- charum officinarum, L.) wax. The aim of this study was to determine the stability of the proposed formulation of D-003 5 mg film-coated tablets, following International Harmonization Conference guidelines for knowing their possible specifications change on storage conditions and for predicting their expiration date. Specifica- tions such as D-003 content, color, tablet weight, hardness, disintegration time, and microbial content were assessed. Stress testing included acid hydrolysis, thermo- lysis, oxidation and photolysis. In addition, accelerated studies under drastic con- ditions: 40 oC and 75 % of relative humidity (RH) as well as long-term studies (48 months) at conditions of Climatic Zones IV (30" @default.
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- W1511247418 date "2006-01-01" @default.
- W1511247418 modified "2023-09-28" @default.
- W1511247418 title "Stability studies of film-coated tablets containing 5 mg of D-003 as active ingredient" @default.
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