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Maintenance of Primary Standards in Pharmaceutical Industries

Learn how to maintain the Primary Standards in pharmaceuticals.
1.0  Procure primary standard substances with the certificate of analysis.
2.0  Use these certified substances exclusively for the volumetric analysis or for calibration of instruments or for appropriate critical tests only.
3.0  Transfer the substances from their original container into the glass vial of required size & label it as follows.
Name: Write name of the primary standard.
B.No.: Write batch number of the primary substance as per the log book.
Prepared on: Write the date of transfer of the substance from its original container to the vial.
Use before: Write the use before date as per the logbook.
Sign: Chemist transferring the substance shall sign.

Log book recording

Log book for primary standard contains following columns:

Prepared on
Use before
Prepared By
Checked By

Prepared on: Write the date of transfer of the substance from its original container to the vial.
B.No.: Write batch number as PX/nnn/yy, where X is serial number allotted for the primary substance starting from one (this number is allotted on the basis of first number for first in i.e. serial inclusion of the substance in use & the number will be permanently allotted throughout the life cycle of the substance requirement). nnn is serial number in chronological order for the transfer of the substance, starting with 001. yy is year i.e. 04 for the year 2004, e.g. P1/001/04.
Use before: All the primary standard substances which are remaining in the vial shall be discarded & replaced with the same substance from the original container every three months or prior if required. Put the date of three months period from the prepared on date. 
Prepared By: Chemist transferring the substance shall sign.
Checked By: Chemist or designee cross checking the activity shall sign.
Dry the primary standard substances at appropriate temperature before use, if required.
Store the substance in well closed vials.
Keep the vials in desiccators over silica gel.

Related: Primary Standards used in Standardization of Volumetric Solutions


Indian Pharmacopoeia
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question

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