Cosmetics

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

This test measures the concentration of the active ingredient at a specific point in time.

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.

These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.

These tests verify the absence of objectionable microorganisms in drug products and raw materials.

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Cosmetic manufacturers and suppliers must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where cosmetic products are produced.

Qualify drug substances, excipients, and drug products to meet pharmacopeia specifications

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

The determination of water content is important in demonstrating compliance with Pharmacopeial standards.