EUPLOID PHARMACEUTICALS PVT. LTD.
Mysuru, Karnataka, India.
TITLE Certificate of Analysis (COA) Page Number 1 of 2
Department Quality Control Effective Date
CERTIFICATE OF ANALYSIS
Name of the Material. Pantoprazole Sodium IP
Mfg. Batch No/Lot No PAS/2405122
Mfg. Date. May 2024 Exp. Date April 2029
Specification No. SPC/FP/002-00 STP No. STP/FP/002-00
Item/Material Code. RMA0001
Metrochem API Private
Manufactured by. Released Date 24/05/2024
Limited
S. No Tests Specifications Results
1 Description White to almost white powder A white powder
2 Solubility Freely soluble in water, and dehydrated ethanol Complies
(95%) Practically insoluble in n- hexane and in
dichloromethane
3 Identification by IR The infrared absorption spectrum obtained with Complies
the test sample should match with that infrared
spectrum of the Pantoprazole Sodium working
standard.
4 Identification by HPLC In the assay the principal peak in the Complies
chromatogram obtained with the test solution
corresponds to the principal peak in the
chromatogram obtained with reference solution
5 Test for sodium It gives reaction of sodium by producing white Complies
precipitate
6 Optical Rotational -0.400 to + 0.400 0.001
solution in water
Related substance by HPLC (% w/w)
7 Impurity C NMT 0.5 0.005
8 Any other unknown NMT 0.50 0.15
impurity
9 Total Impurities NMT 1.0 0.28
10 Heavy metals(ppm) NMT 20 Less than 20ppm
11 Water content by KF 5.0 to 8.0 6.9
(% w/w)
12 Assay by HPLC (% NLT 98.0% and NMT 102.0% Complies
w/w) on dry basis
Format No.: EPPL/SOP/QC/028/F2-00 Ref. SOP: EPPL/SOP/QC/028
EUPLOID PHARMACEUTICALS PVT. LTD.
Mysuru, Karnataka, India.
TITLE Certificate of Analysis (COA) Page Number 2 of 2
Department Quality Control Effective Date
Residual solvents by GC_HS (ppm)
13 Methanol NMT 3000 ppm Complies
14 Acetone NMT 5000 ppm Complies
Prepared By: Approved By:
Format No.: EPPL/SOP/QC/028/F2-00 Ref. SOP: EPPL/SOP/QC/028
