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Pantoprazole Sodium

The document is a Certificate of Analysis for Pantoprazole Sodium, manufactured by Saraca Laboratories Limited. The analysis confirms that the product meets specified standards for various tests, including solubility, identification, related substances, heavy metals, water content, and residual solvents. The report indicates compliance with the standards on the date of analysis, January 10, 2024.

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131 views1 page

Pantoprazole Sodium

The document is a Certificate of Analysis for Pantoprazole Sodium, manufactured by Saraca Laboratories Limited. The analysis confirms that the product meets specified standards for various tests, including solubility, identification, related substances, heavy metals, water content, and residual solvents. The report indicates compliance with the standards on the date of analysis, January 10, 2024.

Uploaded by

PratikBuntyDoshi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd

SAAACA LABOAATOAIES LIMITED

MANUFACTUAEAS OF BASIC DAUGS & INTERMEDIATES


Unit-II, Sy. No. 3/1 to 3/15 & 4/2 to 4/4, Boyapalem Village, Pydlbheemavaram (Panchayat),
Ranasthalam (Mandal), Srlkakulam District· 532 409, Andhra Pradesh, India.

CERTIFICATE OF ANALYSIS

Format No: SLL-II/OC/FMT GEN-006


Name of the product PANTOPRAZOLE SODIUM Reference USP

Batch No. PZ0120240001 Date of Manufacture JAN-2024


Quantity 400 Kg Date of Re-test DEC-2027
A.R.No PZ/24/01/0006 Date of Analysis 10-01-2024
Manufactured By Saraca Laboratories Limited Unit-II Date of Report 10-01-2024

S.No Test Specification Result


1 Description A white to off - white powder Off white powder
Freely soluble in water, in methanol and dehydrated ethanol
2 Solubility
(95%) practically insoluble in hexane and in dichloromethane. Complies
In the Assay, the principal peak in the chromatogram obtained
A. Identification By with the test solution corresponds to the principal peak in the Complies
3 HPLC chromatogram obtained with the reference solution.

B. Sodium A dense, white precipitate should be form. Complies


4 Optical rotation Between -0.40° to 0.40° 0.00°
Pantoprazole Impurity C NMT 0.5% w/w BDL
Related substances
5 Any other secondary peak NMT 0.5% w/w 0.06 % w/w
by HPLC
Sum of all secondary peaks NMT 1.0% w/w 0.18 % w/w
6 Heaw metals Not more than 20 ppm Complies
7 Water Content Not less than 5.0% and Not more than 8.0% w/w 6.0 % w/w
Assay by HPLC
8 (on anhydrous basis)
98.0% to 102.0% w/w 99.4 % w/w
·-
Methanol Not more than 3000 □om 305 ppm
Ethanol Not more than 5000 PPm ND
Acetone Not more than 5000 ppm 220 ppm
9 Residual solvents Acetonitrile Not more than 410 ppm 5 ppm ..

Dichloromethane Not more than 600 ppm ND


Chloroform Not more than 60 ppm ND
Toluene Not more than 890 □om ND
Note : ND: Not Detected, BDL: Below Detectable Limit. . /
Opinion of analysis: The representative sample of above product corffplies/daes-nctcomply with the standards specified above.
Compiled By {Q___ Checked By Approved By

Date Date Date


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Registered Office : Plot No. 320, 1st Floor, East Avenue, Swami Ayyappa Co-Op. Housing Society limited, Madhapur, Hyderabad,
Telangana State - 500 081, Phone : +91-40-23112689/2690, Fax : +91-40-23112691, E-mail : [email protected].

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