ITEM

SPECIFICATIONS

RESULTS

Appearance

White to pale yellow powder

White powder

Identification

Citrates Identification:Positive reaction

Positive reaction

IR: Correspond with the reference standard spectrum

Conformed

Water

2.0% ~ 3.5%

2.7%

Residue on ignition

≤0.1%

0.03%

Heavy Metals

≤10ppm

＜10ppm

Particle Size

D50 ＜ 50um

D90 ＜100um

D50:17um

D90:29um

Related Substances

WI-0489 ≤0.20%

ND

WI-0490 ≤0.20%

ND

WI-0491 ≤0.20%

ND

WI-0571 ≤0.20%

ND

Single Impurity ≤0.20%

＜LOQ （LOQ：0.05%）

（Testing result :0.02%）

Total Impurity ≤0.50%

＜LOQ

Enantiomer WI-0534 ≤0.20%

ND

Residual Solvents

Ethanol ≤ 5000ppm

ND

THF ≤ 720ppm

ND

IPA ≤ 5000ppm

ND

Toluene ≤890ppm

ND

N-heptane ≤5000ppm

ND

Acetone ≤ 5000ppm

307ppm

MTBE ≤ 5000ppm

317ppm

Methanol ≤ 3000ppm

168ppm

Ethyl acetate ≤ 5000ppm

ND

Assay

98.0~102.0% (on anhydrous)

100.4%

Microbiological Items

TAMC ≤ 1000CFU/g

＜10CFU/g

TYMC ≤100 CFU/g

＜10CFU/g

E.Coli : Not to be detected

ND

Conclusion: Conforms to the enterprise standard.