Product Name | Chlorhexidine Gluconate |
Alias | Chlorhexidine digluconate; N'',N'''''-hexane-1,6-diylbis(1-{(1E)-amino[(4-chlorophenyl)amino]methylidene}guanidine) - D-gluconic acid (1:2); N'',N'''''-hexane-1,6-diylbis(1-{(1E)-amino[(4-chlorophenyl)amino]methylidene}guanidine) - D-gluconic acid (1:1); N,N''''-hexane-1,6-diylbis[N'-(4-chlorophenyl)(imidodicarbonimidic diamide)]-hexonic acid (1:2) |
MF | C34H54Cl2N10O14 |
MW | 897.7572 |
CAS | 18472-51-0 |
Molecular Structure | |
Appearance | Almost transparent colorless or pale yellow slightly sticky liquid. Odourless or almost odourless |
HUMAN HEALTH: Surgical scrubs, surgical wipes, surgical lubricants, dental preparations for treatment of gingivitis, hand soaps, skin preparations and cosmetics.
Animal Health & Nutrition: Pet Shampoos, teat dips, lubricants, horse scrubs and solutions to treat skin conditions in both companion animals and livestock.
Chlorhexidine digluconate is commercially available as a 20% (w/v) aqueous solution since the substance cannot be isolated as a solid. It is soluble in water to at least 50% (w/v) but high viscosity makes such concentrated solutions inconvenient to use. Autoclaving of solutions greater than 1.0% can result in the formation of insoluble residues and is therefore unsuitable.
If sterile solutions are required at such high concentrations, then filtration through a 0.22 m membrane filter is recommended. Dilute chlorhexidine solutions may be stored at room temperature, and a shelf-life of at least 1 year can be expected, provided that the packaging is adequate. Prolonged exposure to high temperature or light is to be avoided because this can adversely affect the stability of chlorhexidine solutions. All dilute solutions to be stored should be either heat-treated (sterilized or pasteurized) or chemically preserved (4% isopropanol or 7% ethanol) to eliminate the possibility of microbial contamination. For autoclaved solutions the choice of container material is important, best results being achieved with neutral glass or polypropylene. If soda glass is used with chlorhexidine solutions the resultant pH may be above that which is considered optimal for stability (pH 5-7)because of leaching of alkaline materials from the bottle".
Name | Chlorhexidine digluconate | Check number | 20150705 | ||
Batch No. | 150705A06 | Quantity | 250kg | ||
MFG date | 2015.07.05 | Specification | P1507026 | ||
Test date | 2014.06.11 | Report date | 2014.06.11 | ||
Appearance | This product is light yellow to clarify for almost slightly sticky stiff liquid; odorless or almost odorless. | Conform | Conform | ||
Relative density | Should be 1.060-1.070 | 1.0673 | Conform | ||
Identification | Identification (1), (2), (3) should be positive reaction | positive reaction | Conform | ||
Checking | |||||
acidity | 5% (ml/ml) aqueous solution pH value should be 5.5-7.0 | 6.9 | Conform | ||
P-chloroaniline | The color of the test solution should not be deeper than the control solution (≤ 0.25%) | Conform | Conform | ||
Related substances | Test spots should be shallow impurities in the control (1) the main spots, compared with the control (1) the main spots deep in spots 1-2 impurities should be shallower than the control (2) the main spots | Conform | Conform | ||
Residue on ignition | ≤0.1% | Conform | Conform | ||
Microbial Limit | Bacterial≤100cfu/ml | <1cfu/ml | Conform | ||
Enzyme/microzyme<10cfu/ml | <1cfu/ml | ||||
Staphylococcus glucose aureus, Pseudomonas aeruginosa, white cocci were not detected | Negative |
Assay | This product contains chlorhexidine gluconate (C12H30Cl2N10-2C6H12O7) should be 19.0-21.0% (g/ml) | 19.8% | C conform |
Conclusion | Conform with CP2010 |