Total Yeast & Mold Count (TYMC)

Total Yeast & Mold Count (TYMC) is a microbiological quality control test used to determine the total number of viable yeasts and molds present in a sample. It provides an important assessment of fungal contamination risk in pharmaceutical, nutraceutical, and raw material products.

Yeasts and molds are common environmental organisms that can grow in a wide range of conditions, especially in products containing moisture, natural ingredients, or limited preservative systems. Elevated fungal counts may indicate poor environmental control, raw material contamination, or inadequate preservation.TYMC is essential for ensuring product stability, safety, and compliance with pharmacopeial microbial limits.

Tests We Offer

• Total Yeast & Mold Count — USP <61>/<2021>

Test Methodology

USP <61> Methodology (Microbial Enumeration — TYMC)

Under USP <61>, TYMC is performed using a selective culture-based enumeration method designed to quantify viable yeasts and molds.

• Sample preparation and homogenization to ensure uniform distribution
• Serial dilution where required
• Inoculation onto selective fungal growth media (e.g., Sabouraud-type agar)
• Incubation under controlled temperature conditions favorable for fungal growth
• Growth of yeast and mold colonies over defined incubation period
• Enumeration of colony-forming units (CFU) to determine total fungal load

This method provides a quantitative measurement of fungal contamination levels in non-sterile products.

USP <2021> Methodology (Microbial Examination of Non-Sterile Products)

Under USP <2021>, TYMC testing follows a broader microbial recovery approach, designed to ensure accurate detection of fungi in complex product matrices.

• Sample preparation with consideration for neutralization of antimicrobial preservatives
• Use of appropriate diluents to maintain fungal viability
• Inoculation onto validated fungal growth media supporting recovery of yeasts and molds
• Incubation under aerobic conditions at defined temperatures for fungal development
• Enumeration of all visible yeast and mold colonies
• Application of method suitability testing to ensure no inhibition from product matrix

This approach is especially important for herbal products, dietary supplements, and high-organic-load formulations.

Why It Matters

• Detects and quantifies fungal contamination in raw materials and finished products
• Ensures compliance with USP <61> and USP <2021> microbial limits
• Supports product stability and shelf-life performance
• Strengthens GMP and contamination control programs
• Protects against spoilage and consumer safety risks

How to Connect

Partner with Unicorn Analytical Services for accurate TYMC testing and USP-compliant fungal analysis.