ITEMS

SPECIFICATIONS

TEST Method

Appearance

White to off-white powder

Visual Check

Identification

Infra Red Confirmed

USP197K

Sodium reaction

USP191

Assay

NLT 90%

HPLC/CPC

Loss on drying

≤10.0%

USP731

Protein

<6.0%

USP

pH(1% H₂O solution)

5.5 - 7.5

USP791

Specific Rotation

-12° ‒ -19°

USP781S

Residue on Ignition(dry base)

20% - 30%

USP281

Clarity(5% H₂O solution)

<0.35@420nm

USP

Electrophoretic  purity

NMT2.0%

USP726

Heavy Metal

TOTAL

≤20ppm

Method II USP231

Microbiolgoical Test

Total Bacteria Count

≤1000cfu/g

USP/N.F

Yeast & Mold

≤100cfu/g

USP/N.F

Salmonella

Negative

USP/N.F

E.Coli

Negative

USP/N.F

Staphylococcus Aureus

Negative

USP/N.F

Particle size

100% through 80 mesh

IN-HOUSE