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HOME -> PRODUCTS -> PHARMACEUTICALS -> Glycine USP
 

 

SPECIFICATIONS

 

GLYCINE USP

Date:  November, 2011

 

ITEMS

SPECIFICATIONS

Description

A white, odorless, crystalline powder

having a sweetish taste.

Solubility

Passes Test

Identification (I.R.)

Passes Test

Loss on Drying

0.2% Max.

Residue on Ignition

0.1% Max.

Organic Volatile Impurities

Passes Test

Chloroform

Less than 60 mcg/g

1-4 dioxane

Less than 380 mcg/g

Methylene Chloride

Less than 600 mcg/g

Trichloroethylene

Less than 80 mcg/g

Chloride

Passes Test

Sulfate

Passes Test

Heavy Metals

0.002% Max.

Lead

5 ppm Max.

Arsenic

1 ppm Max.

Iron

10 ppm Max.

Ammonium

0.2% Max.

Assay (C2 H5 N 02,

Calculated on dry basis)

98.5% - 101.5%

Microbiology:

 

Total Plate Count

1,000 CFU/g Max.

Yeast & Mold

100 CFU/g Max.

Coliforms

Negative

E. Coli

Negative

Salmonella

Negative

S. Aureus

Negative

P. Aeruginosa

Negative

Coagulase Test

Negative

Methanol

0.3% Max.

 

 

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