Study Set Content:
Quality Standards and Compendial Requirements for Semi-Solid Dosage Forms Ointments and Creams
Control Tests
• Organoleptic evaluation
• Assay for active ingredients
• Test of rate of absorption
• Test for non-irritancy
• Test of rate of penetration
• Test of rate of drug release
• Test of rheological properties
• Test of content uniformity
• ID test for the active ingredients and possible contaminants
• Loss of water/water content
• pH + Sterility test
• Storage condition
• Stability test
• Minimum Fill
• Metal Particles in ophthalmic ointments
• Microbial Content
Minimum Fill
•
Limitation: Labeled content:
< 150g or 150ml
Sample size: initial:
10 containers, + 20 – Retest
Acceptance Criteria:
- Ave net content is NLT the
labeled content
- If labeled content: is less than 60 mg or ml, but less than 150 g, the percent LC of any single container is
NLT 90%
Fornula LC
\= (𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡)/(𝑙𝑎𝑏𝑒𝑙𝑒𝑑 𝑐𝑜𝑛𝑡𝑒𝑛𝑡) x 100
If labeled content is > 60mg or ml, but < 150g, the % LC of any single container is
NLT 95%
Metal Particles in Ophthalmic Ointments
Acceptance Criteria:
- The total # of metal particles that are
> 50mm
All 10 tubes NMT 50 and NMT 1 tube
> 8 metal particles
Microbial Content
•
Ophthalmic
sterile
Topical
P. aeruginosa, S. aureus
Rectal, Urethral & Vaginal
yeast & molds
Suppositories
Control Tests
•
Organoleptic evaluation
•
Physical strength
•
Melting range
•
Uniformity of drug content
•
Softening time
Conducted using the tablet disintegration test
Macro melting range
Measured using capillary tubes
Micro melting range
This test measures the softening or liquefaction time of suppository which indicates the hardness of the base.
Test for Softening Time
Quality Standards and Compendial Requirements for Liquid Dosage Forms
Control Tests
• Organoleptic evaluation
• Assay of active ingredients and degradation products
• Pourability
• Viscosity
pH control is performed to:
- Maintain solubility of _____ in the formulated product.
therapeutic agent
Enhance the stability of products in which the chemical stability of the active agent is
pH dependent.
is a measure of circular force required to loosen the cap; and application torque is the amount of force used to tighten the cap
Torque test
