Products
Quality Standard of HBV Vaccine
Hepatitis B Vaccine Made By Recombinant DNA Techni...
  Quality Standard of HBV Vaccine
 
SPECIFICATION

 
NAME OF PRODUCT:
Vecon® Recombinant Hepatitis B Vaccine (Yeast)
 
SPECIFICATION:
5μg/0.5ml/dose 
 
UNIT DOSE FORMULA
INGREDIENTS
QUANTITATIVE
ACTIVE OR INACTIVE
HBsAg
5μg
Active
Thimerosal
0
Inactive
Aluminum as hydroxide
0.31mg
Inactive
Sodium Chloride
0.8-0.9%
Inactive
Water for Injection
q.s.
Inactive
 
 
SPECIFICATION:
10μg/1.0ml/dose 
 
UNIT DOSE FORMULA
INGREDIENTS
QUANTITATIVE
ACTIVE OR INACTIVE
HBsAg
10μg
Active
Thimerosal
<2μg
Inactive
Aluminum as hydroxide
0.62mg
Inactive
Sodium Chloride
0.8-0.9%
Inactive
Water for Injection
q.s.
Inactive
 
 
METHOD OF ANALYSIS
 
INGREDIENTS
METHOD OF ANALYSIS
SPECIFICATIONS
HBsAg
Identity（EIA）
Should be HBsAg
Content（Lowry test）
20-27μg/ml
Purity（HPLC）
Higher than 99%
Purity（SDS-PAGE）
20kD-25kD
Thimerosal
Content
<2μg
Aluminum
Content
0.35~0.62mg/ml
 
 
 
 
 
 
 

 
 
Shenzhen Kangtai Biological Products Co., Ltd.         Add: Kefa Road 6, Nanshan district, Shenzhen, China   
ICP:06026377    Tel: 86-755-26988688     Fax:86-755-26988600    Email:office@biokangtai.com