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Poloxamers are also known by the trade names Pluronic, [2] Kolliphor (pharma grade), [3] and Synperonic. [ 4 ] Because the lengths of the polymer blocks can be customized, many different poloxamers exist that have slightly different properties.
There are two essential steps to SFE, transport (by diffusion or otherwise) of the solid particles to the surface, and dissolution in the supercritical fluid. Other factors, such as diffusion into the particle by the SF and reversible release such as desorption from an active site are sometimes significant, but not dealt with in detail here ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
Ablysinol (a brand of 99% ethanol medical alcohol) was sold from $1,300 to $10,000 per 10-pack [Give volume amount please] in 2020 due to FDA administrator action granting exclusivity when used for treating hypertrophic obstructive cardiomyopathy with alcohol septal ablation in the US through 2025, despite "misuse" of the orphan drug act.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
Ethanol fuel specifications worldwide traditionally dictate use of anhydrous ethanol (less than 1% water) for gasoline blending. This results in additional costs, energy usage and environmental impacts associated with the extra processing step required to dehydrate the hydrous ethanol produced via distillation (3.5-4.9 vol.% water) to meet the ...
Ethanol fuel has a "gasoline gallon equivalency" (GGE) value of 1.5, i.e. to replace the energy of 1 volume of gasoline, 1.5 times the volume of ethanol is needed. [4] [5] Ethanol-blended fuel is widely used in Brazil, the United States, and Europe (see also Ethanol fuel by country). [2]