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Psychotropics India Limited: Plot No. - 46 & 49, Sector - 6A, IIE, SIDCUL, Haridwar (U.K.)

The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

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markandey gupta
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247 views1 page

Psychotropics India Limited: Plot No. - 46 & 49, Sector - 6A, IIE, SIDCUL, Haridwar (U.K.)

The document describes a protocol for cleaning validation involving recovering drug from swabs sampled from stainless steel plates spiked with different concentrations of drug solution. The protocol involves spiking plates with different concentrations of drug solution, sampling with swabs, extracting drug from swabs, measuring detector response of extracts, and calculating drug content and recovery percentage.

Uploaded by

markandey gupta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Psychotropics India Limited

Plot No. – 46 & 49, Sector -6A, IIE, SIDCUL, Haridwar (U.K.)

Department: Quality Assurance Document No.: PIL/QA/CV/T/00


Title: Protocol for Cleaning Validation Revision No.: 00
Annex V: Recovery of drug from swabs sampled from spiked S.S. plates Effective Date: 10.05.2015
Page No.: 1 of 1

Recovery of drug from swabs sampled from spiked S.S. plates.

API working standard No. : ____________

Potency: _________

Concentration of solution used for spiking 1 2 3


the S.S.Plates
Concentration of standard solution

Mean Detector response

Drug Swab No. 1 2 3 Mean RSD


Content 
per %
swab
Mean Detector Response
Conc. 1 Content of Drug (mcg/ml)

% Recovery

Mean Detector Response


Conc. 2 Content of Drug (mcg/ml)

% Recovery

Mean Detector Response


Conc. 3 Content of Drug (mcg/ml)

% Recovery

Content of Drug in swab = Mean Detector response of extract solvent X Conc. of standard
____________________________________________________
Mean Detector response of standard.

Analyzed By Checked By
Sign / Date Sign / Date

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