Schedule U describes the particulars to be shown in manufacturing record. Following details are included in Schedule U:
PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS
SUBSTANCES, OTHER THAN PARENTERAL PREPARATIONS IN GENERA
Serial number
Name of the product
Reference...
Size & Shape:It can be dimensionally described & controlled. The thickness of a tablet is only variables. Tablet thickness can be measured by micrometre or by other device. Tablet thickness should be controlled within...
Excipients are crucial to within the body. Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients...
DISINTEGRATION TEST:- This test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions stated below.
APPARATUS:- The apparatus consists of a...