Pharmco Product, Inc.
SOP # : 8-2-3-A
Rev 2.1
2/10/06
EF/PJM
Subject: Expiration Dates for Reagent Chemicals
-1SOP 8-2-3-A
Created by Paul DiMarco
Approval/Effective Date: 01/01/2002
1.) Scope:
Expiration dating policy and procedures for all reagents sold and used in our
laboratory.
2.) Normative References:
SOP 4-2-2 Quality Manual
SOP 7-5-3-C & 4-2-3-I Certificates of Analysis
Form Q401 Laboratory Reagents Spreadsheet
3.) Terms and Definitions:
Reagent Chemical: Any chemical bought or sold that has a grade designation
(USP/NF, FCC, ACS, HPLC etc.)
4.) Application:
All Reagent Chemicals, bought, sold or used in the Laboratory
5.) Text:
SHELF LIFE (EXPIRATION DATES)
Most solvents in their pure state have an indefinite shelf life if stored in unopened
containers under proper conditions. Since many industries require expiration
dating as part of their protocols and since Pharmco has only carried out
verification to three years, expiration dates for most common solvents is three
years from the date of manufacture on the certificate of analysis. This includes
almost all solvents in our catalog such as, Acetone, Methanol, Reagent Alcohol,
IPA (2-propanol), Ethyl Acetate etc. Only certain solvents have shorter shelf
lives. Please consult with us to determine if a particular solvent of interest has a
shelf life shorter than three years. Examples include Formalin 10%. This has a
shelf life of 18 months.
In general, most acids have a shelf life of three years. Additional care must be
taken with Nitric and Sulfuric Acid, as exposure to sun and heat will accelerate
decomposition.
In general, pure 190 and 200 proof ethanol is rated with a shelf life of 36 months
from the date of manufacture. Expiration dates for pure ethanol are recorded on
the label.
Pharmco Product, Inc.
SOP # : 8-2-3-A
Rev 2.1
2/10/06
EF/PJM
Subject: Expiration Dates for Reagent Chemicals
-2SOP 8-2-3-A
Created by Paul DiMarco
Approval/Effective Date: 01/01/2002
The UV component of pure ethanol is extremely sensitive and can fail within
three months depending on the package style. Therefore, shelf life is a function
of customer application.
Most but not all specially denatured alcohol formulations have a shelf life of up to
five years.
Product integrity is highly susceptible to storage condition. All ethyl alcohol
products should be tightly sealed and stored in a consistently cool, dry area. It is
the end user’s responsibility to monitor the storage conditions and their effects on
the product. End users should refer to the applicable MSDS Section VII.
Variances to this expiration date policy are documented on a case-by-case basis.
Note that these expiration dates are based on industry experience with
Pharmco’s products and packaging materials.
Expiration dates for products other then pure ethyl alcohol are not recorded on
the labels unless requested on the customer order.
The manufacturing date and expiration date statement are listed on all
Certificates of Analysis. From these two statements, the expiration date for that
chemical can be determined.
Refer to SOP 7-5-3-C & 4-2-3-I Certificates of Analysis for additional
information.
Laboratory Reagents:
All laboratory reagents are issued expiration dates. The expiration dates are
clearly marked on the reagent bottles. No expired reagents are used in the
quality control laboratory.
Purchased Laboratory Reagents
If the manufacturer has issued an expiration date for a product, that date will be
noted as the expiration date.
If the manufacturer has not issued an expiration date for a product, the date the
product is received by the laboratory will be noted. The product will be issued an
expiration date of 4 years after the product was received.
Pharmco Product, Inc.
SOP # : 8-2-3-A
Rev 2.1
2/10/06
EF/PJM
Subject: Expiration Dates for Reagent Chemicals
-3SOP 8-2-3-A
Created by Paul DiMarco
Approval/Effective Date: 01/01/2002
Laboratory Reagents Prepared In-House
Laboratory reagents prepared in-house are recorded in a laboratory notebook.
Any reagent that is to be “freshly prepared’ will be issued an expiration date of
three weeks after the date on which it was prepared unless otherwise stated.
Any other reagent prepared in the laboratory will be issued an expiration date of
twelve months after the date on which it was prepared unless otherwise stated.
Expiration dates for all laboratory reagents are recorded on Form Q401
Laboratory Reagent Spreadsheet.
Expiration Date Extensions
Expiration dates may be extended if appropriate. Based on an evaluation of the
reagent, the lab staff may extend the reagent’s expiration date. This extension
can not be longer than the original expiration period. The extension is noted on
the reagent bottle and on form Q401 Laboratory Reagents Spreadsheet.
Revision History
Revision
#
2.1
Revision Date
Revised
by
Revision History
started on
2/10/06
2/10/06
EF
PJM/EF
Reason for Revision
Deleted obsolete and fixed outdated info.
Retraining is not required for this revision
This printed document was printed on: 3/12/2007.
This printed document is valid for 5 days after the print date. All obsolete documents must
be appropriately marked or discarded.