Item

Acceptance Criteria

Result

Appearance

White to light yellow crystalline powder

Light yellow crystalline powder

Identification (IR)

Complies

Complies

Particle size distribution D(0.1/0.5/0.9)um

Informative

5.7/113.2/187.8 um

pH

2.6 ~4.1

3.1

Water (K.F.)

9.0% ~ 12.0%

10.8%

Sulphated ash

≤0.2%

0.04

Assay

95.0% ~102.0%（on anhydrous substance）

100.6%

Related substances

Impurity A

≤0.5%

0.06%

Impurity B

≤0.5%

N.D.

Impurity C

≤0.5%

0.05%

Impurity D

≤0.5%

0.03%

Impurity E

≤0.5%

0.11%

Impurity F

≤0.5%

N.D.

Any unspecified impurity

≤0.10%

0.03%

Total

≤3.0%

0.22%

Residual solvent- Acetone

≤0.5%

0.20%

Microbial enumeration testes

Total aerobic microbial count (TAMC)

≤10³ cfu/g

0

Total combined yeasts/molds count (TYMC)

≤10² cfu/g

0

Conclusion

Conforms to EP