1.0) Description: Visual
2.0) Average Weight: Check weight of 20 tablets at randomly and calculate the average weight by formula : Weight of 20 tablets (in gm) x 1000 / 20. Found avg. wt in mg
3.0) Uniformity of weight:
Weigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in table.
|Average weight of tablet contents||Percentage deviation|
|80 mg or less||± 10 %|
|More than 80 mg but less than 250 mg||±7.5 %|
|250 mg or more||±5 %|
The absorbance of the assay preparation corresponds to that of the standard preparation.
5.0) Disintegration Test: Unless otherwise stated in the individual monograph, introduce one tablet into each tube and add a disc to each tube. Suspend the assembly in the beaker containing about 900 ml of water and operate the apparatus for the specified time. Remove the assembly from the liquid. The tablets pass the test if all of them have disintegrated. If 1 or 2 tablets fail to disintegrate, repeat the test on 12 additional tablets not less than 16 of the total of 18 tablets tested disintegrate. If the tablets adhere to the disc and the preparation being examined fails to comply, repeat the test omitting the discs. The preparation complies with the test if all the tablets in the repeat test disintegrate.
6.0) Hardness: The standard method used for tablet hardness testing is compression testing. The tablet is placed between two jaws that crush the tablet. The machine measures the force applied to the tablet and detects when it fractures. Although compressive force is applied to the tablet, along the diameter of the tablet at right angles to the applied force.
7.0) Assay of active ingredients:
(A) Iron (III) hydroxide, polymaltose complex, eq.to elemental Iron:-100mg/tab by Color Development-Method:
- Strong ammonia solution
- Dil sulphuric acid
- 20% Citric acid
- Thioglycolic acid
- Standard: Weigh accurately about equivalent to 50 mg of carbonyl iron in 100ml volumetric flask and add 10 ml of dilute sulphuric acid and boil to dissolve and cool and make up the volume up to the mark with water. Take 5 ml of this solution in 25 ml volumetric flask and make up the volume with water.
Test solution: Weigh accurately about eq. to 50 mg of elemental iron in 100 ml volumetric flask and add 10 ml dil sulphuric acid and boil to dissolve and cool and make up the volume up to the mark with water. Take 5 ml of this solution in 25 ml volumetric flask and make up the volume up to the mark with water.
Procedure: Take 5 ml sample and standard in different 25 ml volumetric flask and add 2 ml citric acid solution (20%) + 0.5 ml thioglycolic acid + 5 ml strong ammonia solution. And make up the volume with water up to the mark. Take reading on spectrophotometer in 525nm,
Note – Shake well before taking reading.
Test abs STD wt. 5 5 100 25 25
Iron =: ——— x ———— x ——- x ——- x ——–x———-x———xAv wt x potency.
(Mg/tab) STD abs 100 25 25 Spl wt. 5 5
(B) Folic acid: 1.0mg/ tablet by HPLC:
Mobile phase: Buffer + Methanol+ Acetonitrile
500 + 300 + 200
Buffer: 3.4 gm of potassium dihydrogen ortho-phosphate in 500ml water adjust the pH 6.0 with TEA.
Column: C18 (250mm x 4.6 micr.)
UV- Wavelength: 260nm
30 mg of folic acid w.s. in 100ml v.f. dissolve with m.p. sonicate for 10min. and then make up to mark with mobile phase. Filter. 5ml of above solution in 50ml v.f make up to mark with mobile phase,
Eq. to 3 mg of Folic acid w.s. in 100ml v.f. dissolve with m.p. sonicate for 10min. and then make up to mark with mobile phase. Filter
Test area x STD wt x 5 x 100 x potency x avg. wt.
STD area x 100 x 50 x test wt. x 100
(C) Cyanocobalamin: 15mcg/ tablet by HPLC:
The following solutions should be used within 1 hour of preparation.
Test solution (a). Dilute a suitable weight of sample, if necessary, with the mobile phase to produce a solution containing 0.0001 per cent w/v of Cyanocobalamin.
Test solution (b). Dilute a suitable volume of the sample, if necessary, with the mobile phase to produce a solution containing 0.05 per cent w/v of Cyanocobalamin.
Reference solution (a). Dilute a suitable volume of the sample, if necessary, with the mobile phase to produce a solution containing 0.003 per cent w/v of Cyanocobalamin.
Reference solution (b). Add 1 ml of a 0.1 per cent w/v solution of chloramine T and 0.1 mI of 0.05 M hydrochloric acid to a volume containing 5 mg of Cyanocobalamin, dilute to 10 mI with water, shake and allow standing for 5 minutes. Dilute 2 mI of this solution to 10 mI with the mobile phase and use immediately.
A stainless steel column 25 cm x 4 mm, packed with -ocijlsilane bondeatoporoussilicll(5µ)
Mobile phase: a mixture of 147 volumes of a 1.0 per cent w/vsolution of- disodium-hydrogen- phosphate and 53 volumes of methanol, adjusted to pH 3.5 with phosphoric acid (to be used within 2 days of preparation),
Flow rate. 0.8 ml per minute,
Spectrophotometer set at 361 nm,
Injection volume. 20 µl.
Allow the chromatography to proceed for three times the retention-time of the-peak due -to cyanocobalamin