It protects the content from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution.

protects the contents from contamination by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is capable of tight re-closure

It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution. It is intended for injection or parenteral preparation

It reduce light transmission sufficiently to protect a light sensitive pharmaceutical. AMBER bottles

container that is significantly difficult for children under 5 years of age to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly.

packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred.

These containers include blister pack, foil, fusion-sealed ampuls and prefilled syringes and cartridges. cannot be resealed with assurance

a hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion. containers are vials and bottles.

highly resistant borosilicate glass.

treated soda lime glass

soda lime glass

General purpose soda lime glass

rigid and has good clarity; useful in blister packaging of tablets and capsules. It not suitable when gamma sterilization is required

have excellent transparency and luster can be sterilized with gamma radiation

PVC

PET

APET

PETG

Used primarily for liquid dosage forms

Used for dispensing liquids of low viscosity

Used for bulk powders; large quantity of tablets/capsules

Used to dispense semi-solid dosage forms; e.g. Ointments & creams

Used for applying liquid medication to a wound or skin surface

Used for powders to be applied by sprinkle

Used for dispensing supp

For aerosol products

for ophthalmic, nasal or otic solution and suspension.

use by man to supplement the diet by increasing the total dietary intake

USP verified program- meet USP requirements (safety)

To ensure the stability of a pharmaceutical preparation for the period of its intended shelf life, the product must be stored in proper conditions.

the ability of the pharmaceutical dosage form to maintain the physical,chemical, therapeutic and microbial properties during the time of storage & usage by patients.

may cause Undesired change in performance;

-Nonproprietary and Proprietary name of the drug.

-Name and address of manufacturer.

-Dosage strength or potency.

-Type of dosage form.

-Net content

-Prescription logo and Legend statement.

-Label reference to see the accompanying package insert.

-Special storage instructions

-Bar code and Registration number

-Lot or control number.

-Expiration date.

-the symbol “C” and the statement “Warning: Maybe habit-forming”

-Nonproprietary and Proprietary name of the drug

-Dosage strength or potency

-Type of dosage form

-Net content.

-Therapuetic use of the drug.

-Directions for use, including any precautions, auxilliary label as indicated on the prescription.

-Expiration date.

-Name of the Patient and Date.

-APPEARANCE

-PALATABILITY

-UNIFORMITY

-DISSOLUTION

-SUSPENDABILITY

chemical process

-Sterility

-resistance to microbial growth

Therapeutic effect remains unchanged.

no significant increase in toxicity

drug cannot be used after this date because the conc. of drug decreased & become lower than therapeutic concentration.

not beyond 6 months expiry date.

not later than 14 days (stored at cold temp) expiry date

not later than 30 days expiry date.

if drug is stored only in room temparature then it will lessen to

-Non-aqueous liquids & solids = not beyond 6 months

-Water containing preparations in solid form = not later than 14 days (stored at cold temp)

-All other preparations = not later than 30 days

Refers to the length of time that a drug produced may remain on the pharmacist’s shelf in the original packages and under usual environmental condition

-Retain an acceptable level of its original potency and overall quality.

-If storage condition are not met, either physical degradation or chemical deterioration may occur

-Solid dosage forms (Tab & Cap)- shelf life 5yrs from the date of manufacture.

-Liquid dosage forms; dispersed systems-aerosols, emulsions; semi-solid (Oint & Supp) shorter shelf life.

Solid dosage forms (Tab & Cap)

Any temperature not exceeding 8 degrees Celcius

Refrigerator

Freezer

Any temperature between 8 to 15C

The temperature prevailing in a working area

Temperature between 20 to 25C or sometimes 15 to 30C

Any temperature between 30 to 40C

Any temperature above 40C

Risks of freezing: breakage of container; loss of potency/strength; destructive alteration of the dosage form.

the content of the container mixes with the drugs.

the drug reacts to the container.

Pharmacologically active

Pharmaceutically active

Generic name

Brand name, trade name

shake well before using; for external use only.

round, flat, amber, wide mouth