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New Generation of Tap Density Tester

PT-TD300 is used to test the tapped (or “tamped”) density and apparent density of powders, granules, pigments and similar products in compliance with the current USP <616> methods 1 and methods 2 as well as with EP <2.9.34>, DIN EN ISO 787-11 and ASTM B527. The instrument automatically calculates the tapped density, Hausner flowability ratio and Carr compressibility index after each test and documents the results via the integrated protocol printer.

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Waiver of In Vivo Bioavailability and Bioequivalence Studies

The BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability. When combined with the dissolution of the drug product, the BCS takes into account three major factors that govern the rate and extent of drug absorption from IR solid oral dosage forms: (1) dissolution, (2) solubility, and (3) intestinal permeability.

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Dissolution Instrument Qualification

Qualification of dissolution instruments has always been challenging. The performance of the apparatus can be influenced by variability in several mechani­cal properties of the apparatus. Recently, there have been significant changes in regulatory and compen­dial guidances related to the qualification of these instruments. Despite the recent advances, there are still challenging outstanding issues. For these reasons, it is imperative that organizations that are generating dissolution data understand the challenges associated with qualification of dissolution apparatuses, become aware of the recent changes, and take steps to address the changes in their operational activities.

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Outing to Belitung

On April 7th-10th , PT. Pharma Test Indonesia held an outing to Belitung. Tanjung Tinggi, known as the shooting site of “Laskar Pelangi” movie gave a very beautiful view of large stones and blue sea. The replica of SD Muhammadiyah Gantong in the movie was also visited.

Pulau Lengkuas which had a very old lighthouse (from 1882) was a primadona in this trip and it also gave a very beautiful view of Belitung from 70 meter above. Not only from the top, was the underwater life under the sea around Pulau Lengkuas very beautiful with clear water, fish and coral reefs.

The trip was ended by visiting the traditional house of Belitung and Danau Kaolin. It was a very relaxing and open-minding trip for the staffs.

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