The factory has a complete Q.A. & Q.C.system. We own several sets of analyzing instruments with high efficiency and high sensitivity, such as HPLC, GC and UV spectrophotometer to analyze and control the products. The company has gotten the approval of SGS to be as audited supplier.
We have specialized in this line for many years and the quality can be surely guaranteed. Any test order will be welcomed.
High Performance Liquid Chromatography HPLC
HGH samples should be tested according to following items
Items of Test | Standard | |
Characters | White lyophilized powder | |
Identification | ||
A. | IEF | CORRESPONDS TO THE REFERENCE |
B. | HPLC/RP | CORRESPONDS TO THE REFERENCE |
C. | PEPTIDE MAPPING | CORRESPONDS TO THE REFERENCE |
D. | HPLC/SEC | CORRESPONDS TO THE REFERENCE |
RELATED PROTEINS (HPLC/RP) | ≤ 13.0% | |
DIMER&RELATED SUBSTANCES OF HIGHER MOLECULAR MASS (HPLC/SEC) |
≤ 6.0% | |
ISOFORM DISTRIBUTION | CORRESPONDS TO THE REFERENCE | |
WATER | ≤ 3.0% | |
BACTERIAL ENDOTOXINS | < 5.0 IU/mg hGH | |
HOST-CELL-DRIVED PROTEINS | ≤ 30 ng/mg hGH | |
HOST-CELL & VECTOR-DERIVED DNA | ≤ 10 ng/dose hGH | |
TEST FOR STERILITY | conformed | |
ASSAY (HPLC/SEC) | 89.0% - 105.0 % the amount of Somatropin stated on the label | |
Purity (HPLC) | ≥ 95% |
The Testing Procedures:
The Factory have hundreds of tests that are used to determine purity, potence and quality of the materials and end products all of which utilize state of the art equipment which ensures complete accuracy.
Product Testing:
At any point during production a product may be tested. If it doesn't meet regulation standard the batch is immediately withdrawn and in the final stages of production the product must undergo the final quality control procedures before it may receive the 'pass' grading which releases it for sale.
Repeated Checks:
As well as the standard checks the raw materials and finished products are tested for heavy metal content. In recent years there has been a significant problem with the underground Factory's producing poor quality products that are filled with toxic heavy metals. This is because they are no licensed and therefore under no obligation to test for these; when you buy cheap products - you pay the price with your health.
While the level of heavy metals found in the raw materials may be acceptable, once it has been mixed with other compounds and reactions taken place these levels can change. Testing throughout the production process therefore ensures our Factory only ever release the safest and most effective compounds.
Lab Test
To make sure the products are at great quality,we will test each batch products for 3 testing.All products purity are pure.