Active substance content

Chalus, E, Roggo, Y., Walter, S., and Ulmschneider, M. (2005), Near-infrared determination of active substance content in intact low-dosage tablets, Talanta, 66,1294-1302. 

Brandi M, Bachmann D, Reszka R, Drechsler M, inventors (Max-Delbrueck-Centrum Fuer Molekulare Medizin, Germany), assignee. Unilamellar vesicular lipids for liposomal preparations with high active substance content. Application US. US patent 97-803435 6399094. 2002 19970220... 

Where an active substance is present as an ester or a salt, the active substance content must be expressed as the amount of the ester or salt present (as the technical material) with a statement dedaring the amount of the active principle. 

Menadione content of this complex is only 4,2-4,5 th ls its practical utilization is not economic y -cyclodextrin however forms 1 1 crystalline complex with menadione (25)-If the single dose of a drug is not more than 25 mg then even a complex of 5 active substance content can carry the necessary dose in a single tablet of 5DO mg weight. Thus, in the case of complex forming drugs, the relationship of the required dose and the molecular weight determines the feasibility of oral administration in cyclodextrin complexed form. 

The average weight and the uniformity of mass are indicators for the weight distribution of the powder over the capsules. The weight distribution depends on the flowability of the powder, the completeness of filUng and the operator s precision. However, it does not give information on the active substance content per capsule. Due to mixing variation there will never be a perfect content uniformity. 

For stock preparations - when no fixed number of suppositories have to be dispensed - pouring may be continued until all mass has been used, but the last filled suppositories will have a low active substance content (see Fig. 11.5). The last 2 suppositories usually do not meet the requirements and in batches of more than 100 even the last 4. 

The concentration of the antioxidant is related to the total volume of the preparation instead of the active substance content, since the volume determines the oxygen content. When a preparation that contains an antioxidant has to be diluted, caution should be exercised to ensure that the end concentration of the antioxidant is not too low to be effective. 

For pharmacy preparations, limits of 90-110 % apply to the entire shelf life (see Sect. 32.6). As an example the shelf life of the Dutch standardised preparations in the FNA is based on a maximum content decline of 5 %. When 10 % decline would be allowed, the chance on the active substance content falling below the lower limit of 90 % would be unacceptably high. If setting the limit for decline of content at 5 % would result in unacceptable storage conditions or an unacceptably short shelf life, it can be reasoned to accept a decline of 10 %. 

The purity of the raw material will affect the active substance content of the finished product and requires factorisation. This means correcting the quantity of a raw material to be weighed for the active substance content deviating from 100 % in the raw material. The content requirements of the finished product and the recommendations concerning factorisation can be found in Sect. 32.4. 

Active substance content (% minimum) 95 Specific gravity at 73F/23C (g/cm3) 1.07 Melting point (min.) 169F/76C Discoloration Discoloring and staining... 

Form Vulkanox 4020 LG Brown to brown-purple pastilles Vulkanox 4020 Fused Liquid Active substance content (% min.) ... 

The synergistic interactions of alkyl polyglycosides with the various primary surfactant systems enables the product developer to formulate even more effective products for the same active substance content or to reduce the active substance content without affecting the performance level (Fig. 23). 

---