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1. Brief instruction:

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In the field of pharmaceutical industry, Chirality**, the concept is of great practical importance because most of biomolecules and pharmaceuticals are chiral. The chiral molecule has the ability to rotate plane-polarized light. The rotation of light is measured using a polarimeter and is expressed as optical rotation. This is a common technique in studying chirality.​

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In pharmaceutical company, quality control is the key point in the process of manufacturing drugs which will ensure the drug’s quality and safety. Product inspection and process control inspection are the key chains in FDA and GMP requirements. This is related to the inspection instruments.

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Insmark Digital Polarimeter (FD series) mainly used in food and pharmaceutical industry. This instrument has special designed software which meets the U.S. federal standard 21CFR requirements. The software will ensure the measurement data are true and reliable through a series of measures, such as user rights management, audit trail documents, electronic records, electronic signatures, data security transmission software.

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Polarimeter can be used to characterize the chiral drugs, such as Cephalosporin antibiotics, most of amino acids, vitamins, antiviral drugs which have chiral characteristics. The sample in this case is Valsartan. Valsartan can be used in various types of hypertension, and has a better protective effect on the heart and kidney. The specific rotation index of valsartan is an important index to test the quality of this medicine.

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  2. Operation process:

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2.1. Sample from: Zhejiang XX Pharmaceutical Company

2.2. Instrument: IP-digiFD2 Polarimeter (FD: Food and Drug system)

2.3. Laboratory: with air-conditioner. Humidity control device

2.4. Room temperature: 22.0 ℃, Humidity 42%

2.5. Operation procedure:

1) The instrument installation will be done by the Insmark Engineer. Performing IQ test,  install the digi_link_FD data output software on the customer computer

2) Training the laboratory administrator (Admin.), and set up the software according to  the specific requirements of the laboratory

3) Complete the OQ verification, verify the accuracy and repeatability of the instrument  with the standard quartz tube, and verify the accuracy of the thermometer

4) Train the operator to take a actual sample measurement

​a.  Sample preparation: weigh the sample 1 gram, transfer it to a 100ml volumetric flask, add MeOH solvent to dissolve it. Mix it well, then add MeOH to the mark.
b.  Setting the measurement method: all the methods only can be set by the Admin. IP-digiFD2 has thermostat system(Peltier). Admin can set temperature at 20.0℃ to ensure the accuracy of the measurement.
c. Operator log in his own account to take the sample measurement.

    ➢   Operator can select an corresponding method. 

    ➢   Add MeOH solvent to the 1dm thermostat sample tube to ‘zero’ the instrument. 
    ➢   Add sample to the same sample tube, take the sample measurement.
    ➢   The operator signed and submitted his measurement result.

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d.  The admin approve the measurement data. Transfer the data to PC in PDF format, this will ensure that the data is true and reliable without tampering.

e.  After all the training sections, the administrator sign the documents.

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  3. Conclusion: 

The customer is fully satisfied with the FD Polarimeter. This instrument  operation system meets the requirements of 21CFR and GMP. This will help the QC  department in improving the quality of data integrity management, farther more  in product quality control management.

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* S.O.R. Specific Optical Rotation

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** Chirality is a geometric property of some molecules

and ions. The presence of an asymmetric carbon center 

is one of several structural features that induce chirality 

in organic and inorganic molecules.