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Index
»
QUALITY CONTROL 2 LEC
»
Compendial Requirements for Liquid Dosage Forms
»
Level 1
level: Level 1
Questions and Answers List
ORAL LIQUIDS
level questions: Level 1
Question
Answer
It includes both the mass of the dosage form and the content of the active substance in the dosage form. It is applied to both single-dose and multiple-dose packages. The dosage unit is considered to be the typical dose taken by the patient.
UNIFORMITY OF DOSAGE UNITS
Acceptance criteria for pH should be provided where applicable and the proposed range justified
PH
Acceptance criteria should be set for the total count of aerobic microorganisms, total count of yeasts and molds, and the absence of specific objectionable bacteria.
MICROBIAL LIMIT
Give the MEDIUM, TEMPERATURE, AND DURATION of the following 1 TOTAL AEROBIC COUNT 2 TOTAL YEASTS AND MOLDS
. 1 MEDIUM: Tryptone, Soya Agar/broth TEMPERATURE: 30°C-35°C DURATION: 48-72 hours 2 MEDIUM: Potato Dextrose Agar TEMPERATURE: 20°C-25°C DURATION: 5-7 days
Release testing for __ should normally be performed. Under certain circumstances, where justified by developmental and stability data, shelf-life testing may be unnecessary
antioxidant content
Tests and acceptance criteria for __ from the container/closure system components (e.g., rubber stopper, cap liner, plastic bottle, etc.) are considered appropriate for oral solutions packaged in non-glass systems, or in glass containers with non-glass closures
extractables
Declared quantitatively on the label in accordance with pertinent regulations, the __ should be specified. It may be assayed or calculated.
alcohol content
ALCOHOL CONTENT PERCENTAGE 1 Children under 6 years of age 2) 6- 12 years of age 3 Over 12 years of age and adults
. 1) 0.5% 2) 5 % 3) 10%
refers to the process by which the solid or liquid components of the dosage form disperse and dissolve in a liquid solvent, typically water or another suitable liquid medium. Often evaluated during pharmaceutical development to ensure appropriate release and bioavailability of the active ingredients.
dissolution of a liquid dosage form
Acceptable __ in terms of the percent of total particles in given size ranges. The mean, upper, and or lower particle size limits should be well defined.
PARTICLE SIZE DISTRIBUTION
refers to the ability of a solid or semi-solid particulate material to disperse or reconstitute into a homogeneous state after it has undergone dispersion or dissolution. This property ensures that medications can be properly distributed throughout the solution, enhancing their effectiveness and providing consistent dosing for better patient experience vital for optimal bioavailability and ensuring that patients receive the intended therapeutic benefits from oral medications.
REDISPERSIBILITY
It is relatively viscous solutions or suspensions, appropriate to __ (viscosity/specific gravity). Data generated during product development may be sufficient to justify skip lot testing, or elimination of this attribute from the specification may be proposed
Rheological Properties
Criteria for __ should be provided for dry powder products which require reconstitution. The choice of diluents is for the product to be administered.
reconstitution time
Oral products requiring reconstitution a test and acceptance criterion for __ should be proposed when appropriate. loss and drying is considered sufficient if the effect of absorbed moisture vs. water of hydration. In certain cases a more specific procedure (e.g., Karl Fischer titration) may be preferable.
water content
