R. N. LABORATORIES PVT. LTD.

Certificate of Analysis
Product Name Chlorhexidine Gluconate 20 % Solution
Reference USP/EP/BP AR. No. FP/I/20/0158
Batch No. RNL/CHG/20/20/025 Batch Size 4200 Kg
Mfg. Date 13/03/2020 Exp. Date 12/03/2023
Release Date 16/03/2020

 
Sr.
Tests Specification Reference Results
No.
Almost colorless or pale yellowish, A Clear, colorless
1. Description USP/EP/BP
clear liquid. liquid.
Miscible with glacial acetic acid and
with water; miscible with three times
its volume of acetone and with five
times its volume of dehydrated alcohol; USP Complies
Solubility further addition of acetone or
2.
dehydrated alcohol yields a white
turbidity.
Miscible with water, with not more
than 3 parts of acetone and with not EP/BP Complies
more than 5 parts of ethanol (96%).
IDENTIFICATION:
3. The IR Spectrum obtained with sample
A. IR should correspond with that of USP/EP/BP Complies
standard.
The principal spot in the chromatogram
obtained with the test solution should
B. Thin Layer be similar in position, colour and size
USP/EP/BP Complies
Chromatography to the principal spot in the
chromatogram obtained with the
reference solution.
C. Residual melting
132°C to 136°C. EP/BP 134.2°C
Point
D. Chemical Test A deep red color should be produced. EP/BP Complies

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 R. N. LABORATORIES PVT. LTD.

Certificate of Analysis
Product Name Chlorhexidine Gluconate 20 % Solution
Reference USP/EP/BP AR. No. FP/I/20/0158
Batch No. RNL/CHG/20/20/025 Batch Size 4200 Kg
Mfg. Date 13/03/2020 Exp. Date 12/03/2023
Release Date 16/03/2020

Sr.
Tests Specification Reference Results
No.
Specificgravity/ Relative
4. 1.06 to 1.07 USP/EP/BP 1.064
density
5. pH(5% v/v) 5.5 to 7.0 USP/EP/BP 6.48
Organic impurities (Related substances)
Chlorhexidineoxazinone
NMT 0.2 % USP/EP/BP BDL
analog (Impurity L)
Specified
unidentifiedimpurity 1 NMT 0.2 % USP/EP/BP BDL
(Impurity Q)
Chlorhexidine amine
NMT 0.3 % USP/EP/BP BDL
(Impurity G)
Chlorhexidine guanidine
NMT 1.0 % USP/EP/BP BDL
(Impurity N)
Chlorhexidine urea
NMT 0.2 % USP/EP/BP BDL
(Impurity B)
p-Chlorophenyl urea
NMT 0.2 % USP/EP/BP ND
(Impurity F)
Chlorhexidine nitrile
NMT 0.4 % USP/EP/BP BDL
(Impurity A)
Chlorhexidine dimer
NMT 0.5 % USP/EP/BP BDL
(Impurity H)
o- NMT 0.4 % USP/EP/BP BDL
Chlorhexidineandspecifi
edunidentifiedimpurity 2
(Sum of Impurity I & O)

Page2of 4
 R. N. LABORATORIES PVT. LTD.

Certificate of Analysis
Product Name Chlorhexidine Gluconate 20 % Solution
Reference USP/EP/BP AR. No. FP/I/20/0158
Batch No. RNL/CHG/20/20/025 Batch Size 4200 Kg
Mfg. Date 13/03/2020 Exp. Date 12/03/2023
Release Date 16/03/2020

Sr.
Tests Specification Reference Results
No.
Chlorhexidineglucityl
NMT 0.4 % USP/EP/BP BDL
Triazine (Impurity J)
Chlorhexidine - USP/EP/BP -
Oxochlorhexidine
NMT 0.4 % USP/EP/BP BDL
(Impurity K)
Any individual
NMT 0.10 % USP/EP/BP BDL
unspecified impurity

6.

Total impurities NMT 3.0 % USP/EP/BP BDL

7. p –Chloroaniline Not more than 500 ppm USP 37.51 ppm

NLT 19.0 % (w/v) and
8. Assay USP 20.15 % w/v
NMT 21.0 % (w/v)

Page3of 4
 R. N. LABORATORIES PVT. LTD.

Certificate of Analysis
Product Name Chlorhexidine Gluconate 20 % Solution
Reference USP/EP/BP AR. No. FP/I/20/0158
Batch No. RNL/CHG/20/20/025 Batch Size 4200 Kg
Mfg. Date 13/03/2020 Exp. Date 12/03/2023
Release Date 16/03/2020

Sr.
Tests Specification Reference Results
No.
Colour absorbance test
9. by UV at 480nm 1% w/v NMT 0.1 In house 0.002
Solution

BDL= below disregard limit; ND= Not detected

If present,o-chlorhexidine and specified unidentified impurity 2 may not be completely resolved by the
method. These peaks are integrated to-gether to determine conformance.

Report:In the opinion of the undersigned, the above batch complies with the standards of specifications
Mentioned under current monographs of USP/EP/BP.

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