2024-12-12  Thursday
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Company Info. 
 
Huatai Biopharm Inc. is the US FDA cGMP  approved leading manufacturer and supplier of ultra-pure and highly concentrated Omega-3 EPA/DHA Fatty Acids for pharmaceutical (Active Pharmaceutical Ingredient-API) and nutraceutical purpose.
 
Huatai Biopharm locates in Deyang, Sichuan, P.R. China. From it's foundation in 1998, Huatai Biopharm  dedicates to research and innovation of purification science and technologies to produce ultra-pure and highly concentrated Omega-3 EPA/DHA fatty acids. The unique and proprietary purification technologies enable the parameters for Oxidation and Environmental Pollutants approach to the most stringent quality standardswhich exceed all known standards such as in GOED,  EU Pharmacopoeia (EP), US Pharmacopoeia (USP) Monograph.
 
  
Products:
 
Omega-3HTM  Pharmaceutical (API)
Omega-3HTM  Nutraceutical
 
 
 
Omega-3H is the Trade Mark of Huatai 's ultra-pure and highly concentrated omega-3 fatty acids,  the 3H means High quality, High purity, and High Value with the lowest limits of Oxidation and Environmental Pollutants, click here to learn more detail information
 
Oxidation
 
Test
Unit
EP
USP
GOED
Omega-3H
Acid value           
mgKoH/g
<2.0
<2.0
<3.0
<1.0 (0.5, ultra)
Peroxide value       
meq/kg
<10
<10
<5
<3   (2, ultra)
Anisidine value
 
<20
<15
<20
<15  (5, ultra)
TOTOX
 
NA
NA
<26
<20  (9, ultra)
 
Environmental  Pollutants
 
Test
Unit
 EP
 USP
 GOED
Omega-3H
Asenic (As)       
mg/kg
 <0.1
 <0.1
 <0.1
<0.1
Lead (Pb)            
mg/kg
 <0.1
 <0.1
 <0.1
<0.05  
Mercury (Hg)                  
mg/kg
 <0.1
 <0.1
 <0.1
<0.005  
Cadmium (Cd)            
mg/kg
 <0.1
 <0.1
 <0.1
<0.01
DDT   (sum: p,p’-DDE + o,p’-DDT +
p,p’-DDT + o, p’-DDD + p,p’-DDD )
mg/kg
 
0.05
 
<0.01
HCB
mg/kg
 
0.05
 
<0.005
Lindane
mg/kg
 
0.05
 
<0.005
PCBs                        
mg/kg
 
0.5
 <0.09
<0.01 
Dioxins like PCBs          
pg /g
 
 
 < 3
< 3  
PCDD+PCDF(Dioxins+Furans)      
pg /g
 < 2
1
 < 2
< 1  
Dioxins+Furans+ Dioxins like PCBs  
pg /g
10
 
NA
< 4
 
 
Purification Science & Technologies
 
Huatai dedicates to research and innovation of Purification Science and Technologies  to produce ultra-pure and higly concentrated Omega-3 fatty acids. In addition to the traditional technologies in edible oil industries, extra process and proprietary purification technologies are adopted in Huatai's production, this enables our Omega-3H branded omega-3 fatty acids approach to the most stringent quality standards, which meet or exceed all known limits set by GOED, EU Pharmacopoeia (EP) , US Pharmacopoeia (USP) Monograph and other institutes.
 
I.    Short-path distillation (Molecular Distillation)
II.   Preliminary purification of crude oil
III.  Proprietary process for removal of organic pollutants
IV  Gentle process protect oil from oxidation and Trans-fattyacid (TFAs)
 
 
Quality Assurance System
 
Huatai Quality Assurance System plays an important role in assuring that the company can provide high quality products and services expected by its customers,
 
Quality Assurance is a commitment to excellence by each Huatai employee. It's achieved through teamwork and a process of continuous improvement.
 
Huatai's Quality Assurance System is in compliance with the following approval and certification.
  • US FDA cGMP
  • NSF GMP
  • HACCP
  • HALAL
  • ISO9001
  • ISO14001
Quality Control
 
Huatai's Analyzing Center (Laboratary.) is equipped with the top-class inspection facilities, such as GC, HPLC, TLC, UV and etc. to act as the role of Quality Control (Q/C) which is in compliance with the following standards.
 
--EU Pharmacopoeia (EP) Monograph
--US Pharmacopoeia (USP) Monograph
--GOED/CRN Omega-3 Voluntary Monograph
 
 
 


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 Omega-3 Monographs
 GOED Monograph
 Ph Eur Monograph
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