Parameter |
Avichlorhex- G Specification (USP) |
Avichlorhex- G Specification (EP) |
Avichlorhex- G Specification (IP) |
Avichlorhex- G Specification (BP) |
Description |
Almost colourless or pale yellowish liquid. |
Almost colourless or pale yellowish liquid. |
Almost colourless or pale yellowish liquid. |
Almost colourless or pale yellowish liquid. |
Solubility in water |
Miscible. |
Miscible. |
Miscible. |
Miscible. |
Identification |
A)I.R. |
IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard |
IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard |
IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard |
IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard |
B) Relative Density |
1.06 – 1.07 |
1.06 – 1.07 |
1.06 – 1.07 |
1.06 – 1.07 |
C) pH (5% v/v Solution) |
5.5 to 7.0. |
5.5 to 7.0. |
5.5 to 7.0. |
5.5 to 7.0. |
Loss on drying |
Maximum 1.0 % w/w. |
Maximum 1.0 % w/w |
Maximum 1.0 % w/w |
Maximum 1.0 % w/w |
Sulphated Ash |
Maximum 0.1 % w/w |
Maximum 0.1 % w/w |
Maximum 0.1 % w/w |
Maximum 0.1 % w/w |
Related substance |
NMT 3% |
NMT 3% |
NMT 3% |
NMT 3% |
Chlorhexidine oxazinone analogue |
NMT 0.2% |
As per EP |
As per IP |
As per BP
Impurity N NMT 1.0% |
Specified unidentified impurity 1 |
NMT 0.2% |
|
|
Impurity H NMT 0.50% |
Chlorhexidine amine |
NMT 0.3% |
|
|
Impurity A NMT 0.40% |
Chlorhexidine guanidine |
NMT 1.0% |
|
|
Impurity J NMT 0.40% |
Chlorhexidine urea |
NMT 02% |
|
|
Impurity K NMT 0.40% |
ρ-Clorophenyl urea |
NMT 0.2% |
|
|
Sum of Impurities I&O NMT 0.40% |
Chlorhexidine nitrile |
NMT 0.4% |
|
|
Impurity G NMT 0.30% |
ο-Chlorhexidine and specified unidentified impurity 2 |
NMT 0.2% |
|
|
Impurity B NMT 0.20% |
Chlorhexidine glucityl triazine |
NMT 0.2% |
|
|
Impurity F NMT 0.20% |
Oxochlorhexidine |
NMT 0.2% |
|
|
Impurity L NMT 0.20% |
Any individual unspecified impurity |
NMT 0.2% |
|
|
Impurity Q NMT 0.20%
Unspecified
Impurities NMT 0.10% |
Limit of p-Chloroaniline |
NMT 500 ppm |
|
|
NMT 100 ppm |
Total impurities NMT 3.0% |
Total impurities NMT 3.0% |
Total impurities NMT 3.0% |
Total impurities NMT 3.0% |
Total impurities NMT 3.0% |
Assay (by potentiometrically) |
Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) |
Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) |
Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) |
Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) |