1.

Stability studies ensuring the maintenance of product quality, safety and
efficacy throughout the shelf life are considered as pre-requisite for the acceptance
and approval of any pharmaceutical product.
Stability studies ensuring the maintenance of product quality, safety and efficacy
throughout the shelf life are considered as pre-requisite for the acceptance and
approval of any pharmaceutical product.

2.
Thermometers can provide accurate temperature information. A
standard thermometer that measures the entire range of foreseeable conditions in a building
is satisfactory.

Humidity indicator strips or color cards are an inexpensive humiditymonitoring device. Some are reversible and thus can be reused, while others are for onetime use. Humidity indicator strips provide only approximate readings, but can be useful for
indicating extreme conditions.

Battery-operated (motor-blower) psychrometer is a hand-held
instrument that measures relative humidity. These are moderately priced and can be moved
conveniently to monitor a wide variety of spaces. Replacement batteries should always be
on hand. It should be noted that they can be complicated to read and require pre-treated
water to operate. The non-battery equivalent, the sling psychrometer, is not recommended
because of the difficulty in getting accurate readings.

An electronic temperature/humidity meter is another hand-held instrument that uses a calibrated sensor to measure RH at a known temperature. 1. pH: • Acidic and alkaline pH influence the rate of decomposition of most drugs. every morning and evening. this can be done at any desired time interval (e. ratio of degraded part to total amount of drug in diluted solution is bigger than of concentrated solution. So. Pharmaceutical dosage forms: solid dosage forms are more stable than liquid dosage forms for presence of water. hydrolysis and reduction reaction b.. Moisture: a. Water catalyses chemical reactions as oxidation. 6. reduction and hydrolysis reaction which lead to drug degradation 2. once a day. 3. . Concentration: rate of drug degradation is constant for the solutions of the same drug with different concentration. Temperature: high temperature accelerate oxidation. Light: affects drug stability through its energy or thermal effect which lead to oxidation 5.g. once a week). • Many drugs are stable between pH 4 and 8. Water promotes microbial growth 4. 3. Min/max digital hygrothermographs keep a record of the highest and lowest temperature and humidity since the instrument was last reset manually.