TYMC - Glossary - peptidetesting.cc

TYMC (Total Yeasts and Moulds Count) is a standardised fungal microbial-enumeration test for the total concentration of viable fungi in a sample. It follows USP <61> and Ph. Eur. 2.6.12 or equivalent pharmacopoeial methods. TYMC reports viable yeasts and moulds together as colony-forming units (CFU), usually CFU/g or CFU/mL, and does not identify species.

TYMC Test Procedure and CoA Reporting

The TYMC test is performed by incubating a prepared sample on Sabouraud Dextrose Agar, a medium that supports fungal growth and helps limit bacterial growth. In aerobic incubation, viable yeast or mould cells grow into visible colonies. Each colony is counted as one CFU, and the total becomes the fungal bioburden result on the Certificate of Analysis (CoA).

On a CoA, TYMC is checked against the relevant pharmacopoeial acceptance limit. Limits depend on the route of administration; inhalation or ophthalmic products have stricter limits than oral solids. A passing TYMC result supports the batch’s fungal-bioburden status, but it does not replace specified-organism testing.

Interpretation Checks and Common Confusions

TYMC is not species identification: it counts viable fungi but does not name species; species-level results need separate testing, such as USP <62>.
TYMC is not TAMC: Total Aerobic Microbial Count measures aerobic bacteria on different media, while TYMC focuses on fungi.
TYMC is not HPLC purity: High-Performance Liquid Chromatography measures chemical purity, not living fungal contamination.
TYMC is not mass spectrometry: mass spectrometry confirms molecular identity, not viable microorganisms.
TYMC is not endotoxin testing: endotoxin testing detects bacterial toxins, while TYMC measures viable fungi.
CoA review: confirm CFU units, an acceptance limit, a referenced method, TAMC results, and specified-organism results.

TYMC Test Procedure and CoA Reporting

Interpretation Checks and Common Confusions

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