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Chlorhexidine Gluconate Solution USP38

Product Name: Chlorhexidine Gluconate Solution

Molecular Formula:C22H30Cl2N10·2C6H12O7

Molecular Weight:897.76 

Synonyms:2,4,11,13-Tetraazatetradecanediimidamide, N,N¢¢-bis(4-chlorophenyl)-3,12-diimino-, di-D-gluconate;     
1,1¢-Hexamethylenebis[5-(p-chlorophenyl)biguanide] di-D-gluconate     

CAS No.:18472-51-0

DEFINITION:

Chlorhexidine Gluconate Solution is an aqueous solution of chlorhexidine gluconate. It contains NLT 19.0% and NMT 21.0% of chlorhexidine gluconate (C22H30Cl2N10·2C6H12O7) (w/v).

IDENTIFICATION:

Infrared Absorption

Acceptance criteria:Meets the requirements

Thin-Layer Chromatographic Identification Test:

Acceptance criteria:The principal spot of the Sample solution corresponds in color, size, and RF value to that of the Standard solution.

Assay: 

Acceptance criteria:  19.0%–21.0% (w/v)

IMPURITIES:

Organic Impurities: 

See the table below:

Name

Relative
Retention
Time

Acceptance
Criteria,
NMT (%)

Chlorhexidine oxazinone analog

0.23

0.2

Specified unidentified impurity 1

0.24

0.2

Chlorhexidine amine

0.25

0.3

Chlorhexidine guanidine

0.35

1.0

Chlorhexidine urea

0.36

0.2

p-Chlorophenyl urea

0.5

0.2

Chlorhexidine nitrile

0.6

0.4

Chlorhexidine dimer

0.85

0.5

o-Chlorhexidine and specified unidentified impurity 2

0.90–0.91

0.4a

Chlorhexidine glucityl triazine

0.96

0.4

Chlorhexidine

1.0

Oxochlorhexidine

1.4

0.4

Any individual 
unspecified impurity

0.10

Total impurities

3.0

Limit of p-Chloroaniline:

acceptance criteria:  NMT 500 µg/mL

Specific Gravity: 1.06–1.07

pH : 5.5-7.0

Packaging and Storage: Preserve in tight containers, protected from light, at controlled room temperature.

 
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