aziCOAT® T20 Specifications and Test Methods

1. Commercial Form

Aqueous emulsions with 20% dry substance

The emulsion contains: Triethyl Citrate USP/NF, EP, DIBUTYL SEBACATE USP/NF, DI Ethyl
Phthalate USP/NF, Mono & Di-glycerides USP/NF, EP, Polysorbate 80 USP/NF, EP, TALC USP,
and Water Treated
The product contains 10.6% to 15.3 % Triethyl Citrate (TEC), DIBUTYL SEBACATE
& DI Ethyl Phthalate (DEP)
The water is routinely tested for total organic carbon, conductivity, and microbial limits.
2. Characters

Description / Appearance:
White viscous liquid with a faint characteristic odour.

Solubility:
The emulsion is miscible with water and acrylic polymer dispersion.

3. Tests

Appearance:
White viscous liquid, absence of foreign material. Shake well before dispensing.
Dispense a minimum of 25ml into a clear/glass container.
• Visually inspect sample – white viscous liquid
• Using a clean spatula move sample in container, visually inspect sample
for absence of foreign material.

Solids Content:
18.5 - 21.5 % as determined by moisture balance set at 105°C for 15 minutes.

• Shake well before weighing sample

• Weigh 0.5g to 1g of sample for test

pH:
2.1 to 5.0 as determined in a room temperature 50mL aliquot with a suitable pH
meter (shake well before dispensing). Kij uhygytfr
Assay:

Citrate level 4.6% to 12.3% as performed by in house method

(shake well before dispensing).

1/2
 aziCOAT® T20 Specifications and Test Methods

4. Purity

Heavy Metals *:
Max. 10 ppm
The test is performed according to USP <231>, method II.
1 gram of EaZiCoat T 20 is used for the test. Shake sample before dispensing.
Residual Solvents*:

Class 3 solvents are likely to be present. Isopropyl Alcohol is present at less than 0.5%
packaging sanitizer) and Ethanol may be detectable after long storage periods at a level
less than 0.5%.
The test is performed according to USP <467>.

Microbial Limits*:
Total aerobic microbial count (TAMC): max. 1,000 CFU/g
Total combined yeasts and molds count (TYMC): max. 100 CFU/g
The test is performed according to USP <61>

* Heavy Metals, Residual Solvents/Organic Volatile Impurities, and Microbial Limits are
performed on a reduced frequency schedule. The reduced frequency schedule is justified
by quality risk management principles.

5. Storage and Handling

Protect from freezing.

Avoid contamination during sampling. Containers that have been opened for use/sampling
should be closed immediately and the contents used up within the next few weeks.

6. Stability
Minimum stability dates are given on the product labels and batch-related
Certificates of Analysis. Storage Stability data are available upon request.

2/2