.
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
|
B.No.
|
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
Related: Primary Standards used in Standardization of Volumetric Solutions
REFERENCE:
Indian
Pharmacopoeia
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