MOD 6: QC/QA - 8

Expiration Date

Identifies the time during which a conventionally manufactured product, AI, or excipient can be expected to meet the requirements of a compendial monograph, provided it is kept under the prescribed storage conditions

Shelf-life

The time lapse from initial preparation to the spcified expiration date; Period of storage and use

Beyond-use date

Date or time beyond which a compounded preparation must be discarded

Short-chain FAs

(Short/Long)-chain fatty acids are derived from Bacterial metabolism

Type 1 / Alpha Error

Type of error in wchich the expiration date was set too early

Type 2 / Beta Error

Type of error in which the expiration date was set too late

Sophistication

Intentional or deliberate type of adulteration; addition of inferior material to an article with an intent to defraud

Substitution

OCcurs when a totally different substance is added in place of original drug

Admixture

Addition of one article to another due to ignorance or carelessness or by accident

Inferiority

Adulteration described as replacement with substandard drug

Spoilage

Adulteration due to attack of microorganisms

Deterioration

Deliberate extraction of the constituent and the sale of the residue as the original drugs

Yellow

Color of CdS

Yellow

Color of Arsenic Sulfide

Orange

Color of Antimony Sulfide

Brown

Color of bismuth sulfide

Brown

Color of tin sulfide

Saccharomyces cerevisiae

[Test Organism] Cylinder Plate Method: Amphotericin B

Micrococcus luteus

[Test Organism] Cylinder Plate Method: Bacitracin

Bacillus subtilis

[Test Organism] Cylinder Plate Method: Dihydrostreptomycin

Micrococcus luteus

[Test Organism] Cylinder Plate Method: Erythromycin

Staphylococcus epidermidi

[Test Organism] Cylinder Plate Method: Gentamicin

S. aureus

[Test Organism] Cylinder Plate Method: Penicillin G

B. subtilis

[Test Organism] Cylinder Plate Method: Vancomycin

P. aeruginosa

[Test Organism] Cylinder Plate Method: Carbenicillin

Saccharomyces cerevisiae

[Test Organism] Cylinder Plate Method: Nystatin

Bordetella bronchiseptica

[Test Organism] Cylinder Plate Method: Polymyxin B

E. coli

[Test Organism] Turbidimetric method: Chloramphenicol

Klebsiella pneumonia

[Test Organism] Turbidimetric method: Dihydrostreptomycin

S. aureus

[Test Organism] Turbidimetric method: Tetracycline