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L-TYROSINE USP 32

(Vegetable Source)

 

SPECIFICATIONS


ITEMS

SPECIFICATIONS

Description

White crystalline powder

Identification

Passes Test

Specific Rotation [a]25D

-9.8° to -11.2°

Chlorides

400 ppm

Sulfates

400 ppm

Heavy Metals

15 ppm

Residual Solvents

Per USP 31

Iron

30 ppm

Ninhydrin-positive substances

TLC

Loss on Drying

0.3 % Max.

Residue on Ignition

0.4 % Max.

Assay

98.5 – 101.5 %

Microbiology:

 

Total Viable Aerobic Count

100 CFU/g

Yeast & Mold

10 CFU/g Max.

E. Coli

Negative / 10 g

Salmonella

Negative / 10 g

Enterobacteriaceae

Negative / 10 g

Pseudomonas Aeruginosa

Negative / 10 g

Staphylococcus Aureus

Negative / 10 g

 

L-TYROSINE USP/FCC

(Low Phenylalanine)

 

ITEMS

SPECIFICATIONS

Description

White or almost white crystalline powder

I.R. Identification

Complies with Reference

Specific Rotation

20°C:  -11.3 to –12.3°

25°C:  -10.0 to –11.0°

Loss on Drying

0.30% Max.

Appearance of Solution

Clear and not more intensely colored than reference solution Y7

Sulfated Ash

0.10% Max.

Heavy Metals

5 ppm Max.

Lead

5 ppm Max.

Iron

10 ppm Max.

Arsenic

1.5 ppm Max.

Chlorides

200 ppm Max.

Sulfates

300 ppm Max.

Ammonium

200 ppm Max.

Phenylalanine

500 ppm Max.

Ninhydrin Positive Substances

0.5% Max.

Assay

99.0 – 101.0%