Container Closure System

There are 4 packaging components provide adequate protection for small-volume Propofol (20ml:200mg)
from moisture and light.
The Primary packaging components for 20ml:200mg (inner package):
Ampoules made of low borosilicate glass tubing
Vial Item Standard

Volume(V)：12.3±1.0ml for 10ml; 23.5±1.0ml for 20ml.

Full height：98.0±1.0mm for 10ml; 120.0±1.3mm for 20ml.

Outer diameter of vial body：17.75±0.25mm for 10ml; 22.00±0.25mm for 20ml.

Vial neck outside diameter：8.0±0.5mm for 10ml; 8.5±0.7mm for 20ml
Size
Vial bubble outside diameter：10.0±1.0mm for 10ml; 12.0±1.0mm for 20ml.

Vial opening outside diameter：7.0±0.4mm for 10ml; 7.4±0.5mm for 20ml.

Height from the vial bottom to vial neck：62.0±1.0mm for 10ml; 76.5±1.5mm for

20ml.

Color：Colorless transparent & transparent brown.

Color wheel or color point：clearly visible.

Glass defect：no significant glass defects.

Appearance
Crack：no crack permitted

Score point：color point should be marked in the center up the score point, and

the deviation to center line should not exceed±1.0mm.

Water resistance of the

≤1.0ml/100ml for 10ml; ≤0.8ml/100ml for 20ml.
inner surface

Runout ≤1.7mm for 10ml; ≤2.4 mm for 20ml.

Breaking force 30-90N for 10ml, 30-100N for 20ml.

Water resistance of Comply with the requirements of class 1(the volume used of HCl(0.02mol/L) ≤

granule in 121℃ 0.10ml.)

Internal stress The optical path difference not more than 40nm/mm.

Identification* Linear thermal expansion coefficient：（6.2~7.5）×10-6K-1（20~300℃）.

 Boron trioxide content：not less than 5%.

Leaching amount of
As≤0.2mg/L；Sb≤0.7mg/L；Pb≤1mg/L；Cd≤0.25mg/L.
metal elements*
The 3 functional Secondary packaging components for 20ml:200mg (outer package):
The Box made of ivory board for 5 vials
Specification: 20ml
Appearance In accordance with the pattern design

Size Length： 14.0±0.1cm

Width： 13.0±0.1cm

Height： 2.9±0.1cm

Thickness 0.52±0.05mm
Weight 22.0±2.0g /box

The outer Carton made of five-ply corrugated board for 100 vials Specification:
Specification: 20ml
Appearance In accordance with the pattern design

Size Length： 29.4±0.3cm

Width： 16.3±0.3cm

Height： 28.5±0.3cm

Thickness 7.0±0.5mm
Weight 0.42±0.03 kg/carton
The outer Carton made of five-ply corrugated board for 200 vials Specification:
Specification: 20ml
Components Five-ply corrugated board
Size Length： 34.8±0.3cm
Width： 31.2±0.3cm
Height： 31.7±0.3cm
Thickness 7.0±0.5mm
Weight 0.84±0.03 kg/carton