One strip contains 5 Capsules. Such one strip is packed in a Carton along with leaflets. The cartons are packed in corrugated boxes & sealed with BOPP tape. Vendors are identified and the packaging materials were analyzed from three different vendors as per the specification. All the packing materials were sourced from certified vendors and duly tests for integrity. Packaging material development was done by using different packaging materials from three different vendors. Also the product was compared with branded market sample.
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All the development records were maintained and their concurrences with succeeding trials were ensured and finally the pivotal batch was packed in the finally selected packaging materials. Packaging material is routinely studied for Compatibility and Stability and the results have indicated that there is no interaction between Primary Packaging Material (Printed poly laminated Aluminium foil & plain poly laminated aluminium foil) and the Drug Product. Further there was no leaching or absorption phenomenon.
The retention times of the principal peaks in the chromatogram obtained with the test solution are approximately the same as those of the principal peaks in the chromatogram obtained with the reference solution. D. 1 ml of solution S gives the reaction of magnesium (2. 3. 1). TESTS Solution S To 5. 0 g add 50 ml of peroxide-free ether R, 20 ml of dilute nitric acid R and 20 ml of distilled water R and heat under a reflux condenser until dissolution is complete. Allow to cool. In a separating funnel, separate the aqueous layer and shake the ether layer with 2 quantities, each of 4 ml, of distilled water R.
Combine the aqueous layers, wash with 15 ml of peroxide-free ether R and dilute to 50 ml with distilled water R (solution S). Evaporate the organic layer to dryness and dry the residue at 100-105°C. Keep the residue for identification tests A and B. Acidity or alkalinity To 1. 0 g add 20 ml of carbon dioxide-free water R and boil for 1 min with continuous stirring. Cool and filter. To 10 ml of the filtrate add 0. 05 ml of bromothymol blue solution R1. Not more than 0. 5 ml of 0. 01 M hydrochloric acid
Allow to cool. Dissolve the residue in water R and dilute to 5. 0 ml with the same solvent. Reference solutions? Prepare the reference solutions using cadmium standard solution (10 ppm Cd) R, diluted as necessary with a 1 per cent V/V solution of hydrochloric acid R. Measure the absorbance at 228. 8 nm, using a cadmium hollow-cathode lamp as a source of radiation and a graphite furnace as atomic generator. Lead? Not more than 10. 0 ppm of Pb, determined by atomic absorption spectrometry (2. 2. 23, Method II). Test solution? Use the solution described in the test for cadmium. Reference solutions?
Prepare the reference solutions using lead standard solution (10 ppm Pb) R, diluted as necessary with water R. Measure the absorbance at 283. 3 nm, using a lead hollow-cathode lamp as a source of radiation and a graphite furnace as atomic generator, depending on the apparatus the line at 217. 0 nm may be used. Nickel Not more than 5. 0 ppm of Ni, determined by atomic absorption spectrometry (2. 2. 23, Method II). Test solution? Use the solution described in the test for cadmium. Reference solutions? Prepare the reference solutions using nickel standard solution (10 ppm Ni) R, diluted as necessary with water R.
