Methods and Materials involved
A tablet is a mixture of active substances and excipients usually in powder form, pressed or compacted into a solid. The excipients include binders, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to ensure that the tablet breaks up in the digestive tract; sweeteners or flavours to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A polymer coating is usually applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life.
The whole manufacturing process deals with the following steps:-
1. Lab testing of pharmaceutical ingredients
2. Manufacturing of tablets (Granulation and Compression)
3. Coating of Tablets
4. Lab testing of tablets
5. Packaging and Sealing
Lab Testing of Raw-Materials (pharmaceutical ingredients)
The tests and assays described are the official methods upon which the standards of Pharmacopoeia are based. Alternative methods of analysis may be used for control purposes, provided that the methods used are shown to give results of equivalent accuracy & enable an unequivocal decision to be made as to whether compliance with the standards of monograph would be achieved if the official methods were used.
The first step deals with the testing of pharmaceutical ingredients. It includes the test for the identification of raw material of pharmaceutical drugs.
Solubility- freely soluble in ethanol(95%); soluble in chlo & in ether; slightly soluble in water.
STANDARDS:- Aspirin contains not less than 93% and not more than 105% of labelled amount of C9H8O4 .
Identification- TEST A may be omitted if tests B,C & D are carried out. TEST C & D may be omitted if TEST A & B are carried out.
A- Infrared absorption spectrum is concordant with the reference spectrum of ASPIRIN or with the spectrum obtained from Aspirin reference spectrum. B- Boil about 0.5g with 10 ml of NaOH solution for 3 minutes, cool & add 10ml of dil. H2SO4, a white ppt. is produced odour of acetic acid is perceptible. Filter, dissolve the ppt. in about 2 ml of water & add FeCl3 test solution; a deep violet colour is produced. C- To the titrate obtained in TEST B & 3ml of ethanol(95%) & 3ml of sulphuric acid & warm; the odour of ethyl acetate is perceptible. D- Melts at about 142 °.
Description- white crystals or white crystalline powder.
Solubility- freely soluble in ethanol(95%); and in acetone; sparingly soluble in water; very slightly soluble in dichloromethane and in ether.
Paracetamol contains not less than 99% and not more than 101.0 percent of C8H9NO2; calculated with reference to the dried substance.
Identification- TEST A may be omitted if tests B,C, D and E are carried out. TEST B,C & D may be omitted if TEST A & E are carried out.
A- Infrared absorption spectrum is concordant with the reference spectrum of PARACETAMOL or with the spectrum obtained from PARACETAMOL reference spectrum B- Dissolve 50mg in sufficient methanol to produce 100ml.To 1ml of this solution add 0.5ml of 0.1M HCl & dilute to 100ml with methanol. Protect the resulting solution from bright light & immediately measure the absorbance at the max. at about 249nm,about 0.44. C- Boil 0.1g in 1ml of HCl for 3 minutes, add 10ml of water and cool, no ppt. is produced. Add 0.05 ml of 0.0167 potassium dichromate; a violet colour develops which does not turn red. D- Gives the reaction of acetyl groups.
E- Melts at about 168° and 172°.
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