ITEMS

SPECIFICATIONS

RESULTS

Appearance

White crystals or crystalline powder

White crystalline powder

Indentification

IR

Positive

Appearance of solution

Clear and colourless

Clear and colourless

Specfic rotation

-29.0~-32.0°

-31.90°

pH

5.5~9.5

7.20

Loss on drying

≤0.5%

0.30%

Residue on ignition

≤0.1%

0.03%

Assay

97.0~103.0%

99.80%

Residual solvents

Residue acetone

Residue Ethanol

≤0.1%

≤0.5%

0.005%

0.10%

Heavy metals

≤ 10PPM

<10PPM

Arsenic

≤ 1PPM

<1PPM

Chloride

≤ 0.4%

<0.4%

Potassium

≤ 0.2%

<0.2%

Sodium

≤ 0.1%

<0.1%

Cyanide

Absent

Absent

Lead

≤ 3PPM

<3PPM

Mercury

≤ 0.1PPM

<0.1PPM

Cadmium

≤ 1PPM

<1PPM

Total plate count

≤ 1000cfu/g

30cfu/g

Yeast & Mold

≤ 100cfu/g

＜10cfu/g

E.Coli

Negative

Negative

Salmonella

Negative

Negative

Conclusion: It conforms to the USP STANDARD.