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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
