Freeman Industries LLC.

ZEIN, REGULAR GRADE F4000

FOR PHARMACEUTICAL, COSMETIC AND FOOD USE

ZEIN is the water-insoluble prolamine protein of corn gluten.

Description:	Straw-to-yellow colored granular powder, bland in taste.
Approximate Molecular Weight:	35,000
Bulk Density Range:	1.25 - 2.1 gm/10ml
Identification Tests:	Positive for (A) and (B) conforms to solubility tests below.
Solubility in Water:	Insoluble
Solubility in 80% alcohol:	Clear to slightly cloudy
ZEIN (Protein):	88-96% calculated on a dry basis
Loss on Drying:	8% maximum (drying for 2 hours at 105 degrees C)
Total Ash:	2% maximum
Heavy Metals:	20 ppm maximum
Arsenic:	3 ppm maximum
Mesh Size:	100% through U.S. 20 mesh
Microbial Limits:	The total bacterial count does not exceed 1000 per gram and the tests for Salmonella species and Escherichia coli are negative.
Standard Packaging:	25 kilo poly bag inside double-walled corrugated cartons (55.12 lbs. net)

ASSAY METHODS FOR ZEIN

Identification Tests

1. Add a few drops of nitric acid t.s. to an aqueous ZEIN suspension - heat it. The solution will be a light yellow color. After adding ammonia t.s., an orange color develops.

2. Add a few drops of copper sulfate t.s. to an alkaline ZEIN solution and warm it in a warm bath. A purple color will develop.

Assay

Proceed as directed under “Nitrogen Determination” (461) USP XXI, p. 1207. ZEIN % x 6.25.

Solubility in Alcohol

Dissolve 1 gm in 10 ml of 80% alcohol.

Loss on Drying

Accurately weigh 2.0 gm of sample into a tared weighing dish. Dry at 105 degrees C for two hours. Cool to room temperature in a desiccator. Weigh and calculate the percent loss on drying as follows:

L.O.D. % = Wt. Sample Wet - Wt. Dry X 100
Wt. Sample Wet

Total Ash

Accurately weigh 2 gm of sample into a large tared crucible. Ignite the contents gently, then heat to a dull red. Cool to room temperature in a desiccator and add 1 ml concentrated sulfuric acid. Slowly heat to 800-850 degrees C. Hold at that temperature for two hours. Cool to room temperature in a desiccator. Weigh and calculate the total ash as follows:

Total Ash % = Sample wt. - Wt. residue X 100
Weight Sample

Heavy Metals

Proceed as directed under “Heavy Metals” (231) USP XXI, p. 1189 Method II

Arsenic

Proceed as directed under “Arsenic” (211) USP XXI, p. 1187