ITEMS

METHODS

SPECIFICATIONS

RESULTS

Description

Melting point

Specific rotation

Identification

 Chemical reaction

GC

Density

Acidity

Heavy metals

* BaP

*PAH₄

Residual solvents

 Hexane

 Ethanol

Assay

  Assay1

  Assay2

Microbial test

Total aerobic microbial count

Total moulds and yeasts count

Enterobacterial

Coliforms

Escherichia coli

Visual

USP<741>

USP

USP

USP

USP<616>

USP

USP<231>

GC-MS

GC-MS

USP<467>

USP<467>

USP

USP

USP<2021>

USP<2021>

USP<2021>

FDA BAM

USP<2022>

White to almost  white crystalline powder or granules, almost odorless

73ºC~78ºC

≥+24°

Positive

Corresponds to RS

0.45g/cm³~0.60g/cm³

18.0mL~19.3mL

≤10mg/kg

≤1.0ppb

≤10ppb

≤0.029%

≤0.5%

96.0%~102%

≥1161.6I.U./G

≤1000cfu/g

≤100cfu/g

≤10cfu/g

≤10MPN/g

n.d./10g

Almost  white crystalline granules, odorless

76ºC~78ºC

+28°

Conform

Conform

0.54g/cm³

18.9mL

<10mg/kg

Certified

Certified

<0.002%

<0.05%

97.2%

1176.1 I.U./G

≤10cfu/g

≤10cfu/g

≤10cfu/g

≤3.0MPN/g

n.d./10g