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METHOD OF ANALYSIS FOR NOVOMIX |
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| >> Appearance |
Finely ground Coloured / White powder free flowing with or without white particles or flakes.
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>> Colour Shade (Comparision of Colour Shade) for Novomix - Plain, MR, ENT :
Disperse NOVOMIX 2.0 gms in the dispersion media with constant stirring in a 100 ml beaker |
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| Preparation of Dispersion Medium as Follows: |
| NOVOMIX |
Plain |
MR |
Enteric |
Enteric |
| Moisture Barrier |
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HPMCP Based |
CAP Based |
| Dichloromethane |
20 ml |
20 ml |
16 ml |
10 ml |
| Methanol |
10 ml |
10 ml |
8 ml |
5 ml |
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 Preparation Of Shade Card
Cut 7 to 8 white paper cards of size 1.5 x 3.5 cm. Pour the slurry prepared on the card and drain out the excess of slurry in the beaker. Similarly prepare such 7 to 8 cards for comparison so as to get a card of same thickness. Compare the colour shade cards with a standard reference colour shade card. The colour intensity should match visually with reference shade card. Also compare the colour of the standard reference card with cards prepared under test using a colour matching system.
pH (2% D.I. Water Slurry):
Take 2 gms of powder, add 100ml distilled water stir for 10 to 15 minutes. Find its pH value.
 Particle Size:
Prepare a 5% dispersion of sample using the dispersion media of Methylene Dichloride and IPA in proportion of 65:35. Thoroughly disperse the material in the dispersion media for about 30 minutes with constant stirring. Pour this dispersion on the top of the 100 mesh tarred sieve in a form of fine stream. Immediately rinse the sieve with three consecutive 50 ml portion of the dispersion media i.e. CH2CL2 and IPA in proportion of 65:35; before there is any film formation on the sieve. Sieve the remaining particles on the sieve without applying any pressure with the help of running water. Continue the wet sieving process until the emerging liquid appears free of particles. Remove the sieve and dry it to constant weight at the temperature of about 105°C. Determine the weight of dried material on each sieve.
Note:
For Ready mix sugar film coating material of aqueous dispersion use 5 % dispersion of the sample in distilled water.
For HPMCP Film Coating Material pass the dispersion through 40 mesh.
For Aqueous Enteric coating, prepare the suspension in distilled water and pass the dispersion through 40 mesh.
For Aqueous coating, prepare the suspension in distilled water.
Calculation : Percentage w/w passed through 100 mesh = 100 x W1 - W2
W1
Where W1 = Weight of sample in gms taken for sieve test.
W2 = Weight of material remained on the sieve i.e. after drying.
Tapped Density.
Weigh exactly 10 gms of that powder. Pour it in a 100ml Graduated stoppered measuring cylinder. Set 100 taps for the bulk densito-meter. Note the volume (A) occupied by 10 gms of the power after 100 taps on the graduated cylinder.
Note : For Enteric Coating Material use 5 gms of NOVOMIX for Bulk Density.
Calculation :
T.D. in g/cc = Weight of the powder = 10gms
Volume A
Limit : Not more than 0.9 g/cc
Specification for 100ml gradated cylinder. Height 9.75 to 10.25 inches, gradated from bottom, upward in ml 7 to 8 inch gradated portion. Standardize with distilled water at 25°C, not more than 1ml.error at any point.
Ash Content :
Weigh accurately 1 - 2 gm of sample in a tarred silica dish, previously heated @ 600 ± 25° C for 15 minutes and then cooled in a desiccator. Incinerate the sample @ 600 ± 25° C for 45 minutes. Allow the silica dish to come to room temperature in a desiccator before weighing. Weigh it for constant weight.
Calculation : Calculate the percentage ash from the given equation.
% Ash = Weight of residue x 100
Weight of sample
Limit Test For Arsenic :
AS per (USP<211>)
Limit Test For Heavy Metals :
AS per (USP<231>)
Loss On Drying @ 105°C for 2 hrs :
Mix and accurately weigh the substance to be tested, and, unless otherwise directed in the individual monograph, conduct the determination on 1 to 2 g. if the test specimen is in the form of large crystals, reduce the particle size to about 2 mm by quickly crushing. Tare a glass-stoppered, shallow weighing bottle that has been dried for 30 minutes under the same conditions to be employed in the determination. Put the test specimen in the bottle, replace the cover, and accurately weigh the bottle and the content. By gentle, sidewise shaking, distribute the test specimen evenly. Place the loaded bottle in the drying chamber, removing the stopper and leaving it also in the chamber. Dry the test specimen at a temperature of 105°C for 2 hours. After 2 hrs close the weigh bottle promptly and allow it to come to room temperature in a desiccator before weighing. Weigh the weighing bottle for constant weight.
Calculation :
% Loss on Drying = Loss in weight x 100
Weight of sample
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