| Customization: | Available |
|---|---|
| Type: | Chlorhexidine Digluconate 20% Solution |
| Appearance: | Liquid |
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| Name | Chlorhexidine digluconate |
| Synonyms | 1,1'-Hexamethylenebis(5-[p-chlorophenyl]biguanide) |
| Molecular Structure | |
| Molecular Formula | C22H30Cl2N10.2(C6H12O7) |
| Molecular Weight | 897.56 |
| CAS Registry Number | 18472-51-0 |
| EC Number | 242-354-0 |
| Density | 1.06 (20% aq.) |
|---|
1.Appearance: almost colourless or pale-yellowish liquid.
2.Solubility : miscible with water, with not more than 3 parts of acetone and with not more than 5 parts of ethanol (96 per cent).
3.Package: 25kgs/Plastic Drum; 5kgs/Plastic Drum;1kg/Bottle
4.Molecular Formula:C22H30Cl2N10.2(C6H12O7)
5.Purity (Assay): 20%
6.Storage :protected from light.
7.Execution standards: BP/EP/USP
The uses of a 20% solution of chlorhexidine gluconate are as follows:
1. Preoperative skin disinfection: Used for deep sterilization of the skin before surgery, achieving broad-spectrum antibacterial effects by destroying bacterial cell membranes, suitable for disinfection in high-risk infection areas.
2. Disinfection of medical equipment or environmental surfaces: High concentration solutions can be used for strict disinfection of hospital equipment, devices, or hard surfaces, killing Gram positive/negative bacteria and some fungi.
3. Treatment of severe wounds or infectious wounds: Diluted and used for flushing purulent wounds, burns, or chronic ulcers to inhibit bacterial growth and promote healing.
4. Anti corrosion preservation: Used as a preservative in drugs or specific industrial products to extend the shelf life.
5. Dental infection control: Diluted and used for severe gingivitis, periodontal disease, or oral postoperative rinsing to reduce oral pathogenic bacteria.
Attention: 20% is a high concentration original solution, which should be diluted as needed before use to avoid direct contact with mucous membranes or eyes.
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Product name: |
Chlorhexidine gluconate (digluconate) 20% solution |
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Nr |
Item |
Limits |
Reference |
|
1 |
Appearance |
Almost colorless or pale yellow clear liquid |
USP/EP/BP |
|
2 |
Solubility |
Miscible with glacial acetic acid and water, miscible three times by its volume with acetone, and five times with dehydrated alcohol, further addition of alcohol or acetone yields a white precipitation |
USP |
|
Miscible with water, with no more than 3 parts of acetoin, and with no more than 5 parts of ethanol (96%) |
EP/BP |
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|
3 |
Identification tests |
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|
A (IR) |
The IR spectrum from the sample should correspond to reference standard |
USP/EP/BP |
|
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B (TLC) |
The principal spot obtained from the test solution in similar color, size and Rf value to that obtained from the reference standard solution |
USP/EP/BP |
|
|
C (Melting point) |
Between 132 °C and 136 °C |
USP/EP/BP |
|
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D (Analytical test) |
A deep red colour should be produced |
USP/EP/BP |
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4 |
Specific gravity |
Between 1.06 and 1.07 |
USP/EP/BP |
|
5 |
pH(5% v/v) |
Between 5.5 and 7.0 |
USP/EP/BP |
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6 |
Related substance |
NMT 3.0% |
USP/EP/BP |
|
7 |
p-Chloraniline |
Less than 500 ppm |
USP |
|
Less than 50 ppm |
In-house statndard |
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Complies test |
EP/BP |
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8 |
Assay |
NLT 19.0% and NMT 21% of chlorhexidine bigluconate |
USP |
|
NLT 190 g/L and NMT 210 g/L of chlorhexidine bigluconate |
EP/BP |
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BP
Certificate of Analysis
| PRODUCT NAME | Chlorhexidine Gluconate 20% Solution | CAS NO. | 18472-51-0 | ||||||
| BATCH NO. | S-202502100 | REPORT DATE | 2025-02-18 | ||||||
| PACKAGING | 25KG/DRUM | MANUFACTURING DATE | 2025-02-10 | ||||||
| BATCH SIZE | 2150.0KG | RETEST DATE | 2027-02-09 | ||||||
| SPECIFICATION | BP2014 | ||||||||
| TEST ITEMS | SPECIFICATION | RESULTS | |||||||
| Appearance | Almost colorless or pale-yellowish liquid | ale-yellowish liquid | |||||||
| Solubility | Miscible with water,with not more than 3 parts of acetone and with not more than 5 parts of ethanol(96 percent) |
Miscible with water,with not more than 3 parts of acetone and with not more than 5 parts of ethanol(96 percent) |
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| Identification | IR | To match with Reference Standard | Conform | ||||||
| TLC | To match with Reference Standard | Conform | |||||||
| Relative density | 1.06~1.07 | 1.066 | |||||||
| pH | 5.5~7.0 | 6.6 | |||||||
| Chloroaniline | Maximum 500ppm | <50ppm | |||||||
| Related substances |
Impurity N | ≤1.0% | 0.12% | ||||||
| Impurity H | ≤0.5% | 0.24% | |||||||
| Impurity A | ≤0.4% | 0.02% | |||||||
| Impurity J | ≤0.4% | 0.03% | |||||||
| Impurity K | ≤0.4% | 0.06% | |||||||
| Impurity I+O | ≤0.4% | 0.12% | |||||||
| Impurity G | ≤0.3% | 0.06% | |||||||
| Impurity B | ≤0.2% | 0.08% | |||||||
| Impurity F | ≤0.2% | 0.02% | |||||||
| Impurity L | ≤0.2% | 0.09% | |||||||
| Impurity Q | ≤0.2% | 0.03% | |||||||
| Unspecified impurities | ≤0.10% | 0.03% | |||||||
| Total | ≤3.0% | 1.01% | |||||||
| Content | 190g/L~210g/L | 203.6g/L | |||||||
| Storage | Protected from light. | ||||||||
| Conclusion:This batch product comply with BP2014 specification. | |||||||||
USP
| ITEM TESTED | STANDARD | RESULTS | ||||||
| Appearance | Almost colorless or pale-yellowish liquid | Pale-yellowish liquid | ||||||
| Identification | 1. IR Spectrum | To match with Reference Standard | Complies | |||||
| 2. BY TLC | To match with Reference Standard | Complies | ||||||
| 3. Chlorhexidine Mp | Chlorhexidine Mp 132ºC~ 136ºC | 133.6ºC~ 133.9ºC | ||||||
| 4.Bromine R Test | Positive Reaction | Complies | ||||||
| Tests | Relative density | Between 1.06 to 1.07 | 1.064 | |||||
| pH (5%) | Between 5.5 to 7.0 | 6.1 | ||||||
| Chloroaniline | Maximum 0.25% | Complies | ||||||
| Related substances (Examine by HPLC) |
Not more than 3.0% | Complies | ||||||
| Assay | Chlorhexidine gluconate solution contains not less than 190g/L and not more than 210g/L of 1, 1 '-(hexane-1,6-diyl)bis[5-(4-chlorphenyl)biguanide]di- D-gluconate. |
202g/l | ||||||
EP
| ITEM TESTED | STANDARD | RESULTS | ||||||
| Appearance | An almost colorless or pale-yellowish liquid | Pale-yellowish liquid | ||||||
| Identification | 1. IR Spectrum | To match with Reference Standard | Complies | |||||
| 2. BY TLC | To match with Reference Standard | Complies | ||||||
| 3.Chlorhexidine Mp | Chlorhexidine Mp 132ºC~ 136ºC | 132.8ºC~ 133.4ºC | ||||||
| 4.Bromine R Test | Positive reaction | Positive reaction | ||||||
| Tests | Relative density | Between 1.060 to 1.070 | 1.065 | |||||
| pH (5%) | Between 5.5 to 7.0 | 6.25 | ||||||
| p-Chloroaniline | Maximum 0.25% | Complies | ||||||
| Related substances (Examine by HPLC) |
Not more than 3.0% | Complies | ||||||
| Assay | Chlorhexidine gluconate solution contains not less than 190g/l and not more than 210g/l of 1, 1 ' -(hexane-1,6-diyl)bis[5-(4-chlorphenyl)-biguanide]di- D-gluconate. |
203g/l | ||||||
FAQ
Question 1: Can I get samples?
Answer: Yes,you can get free samples of our most products,
while the courier cost will be borne by the buyers.
Question 2: What's your MOQ?
Answer: For a express delivery order,the MOQ is usually 100 g~1 kg;
for an air transport order or sea delivery order ,the MOQ is usually 25 kgs.
Question 3: What's your delivery time?
Answer:
Orders shipped by express delivery,the delivery time is usually 5~7 working days;
Orders shipped by air transport,usually around 7~10 working days;
Orders shipped by sea , usually around 2~3 working weeks.
Question 4: What are the different payment methods?
Answer: We usually accept T/T, L/C and Western Union.
Question 5: How do you treat quality complaint?
We take quality very seriously, it is one of the founding principles of our business.
If the quality problem actually exists, we will replace with qualified goods or refund the money.
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