Secondary Raw Material Reference Substance (SRMRS) Summary Sheet

Secondary Raw Material Reference Substance (SRMRS) Summary Sheet


In-house Reference Code

Ref. Sub. Description

Raw Material Code

Laboratory Batch No

Storage Location

Manufacturer

Supplier

Manufacturers Batch No

Storage Temperature
Requirement

Manufacturers Assay &
Assay Description.

Date sample received by
the Laboratory

Quantity
received by Lab
(originally)

Date bottle
first
opened

Manufacturers Expiry
Date

Re-test date (set at 1 year
from in-house testing date)

Date tested/ re-tested in-
house for Assay

Finished Goods control
method used to test Assay

Analyst testing Assay

Workbook reference of
analyst testing Assay

%Water Content (WC) or
%Loss on Drying (LOD)

Raw Material Control
Method used to test WC or
LOD

Analyst testing WC/LOD

Workbook reference of
analyst testing WC/LOD


Assay results
& Description
Expressed as needed during use:
(To appear on label of bottle after testing)

Expressed as in appropriate Pharmacopoeia:
Breakdown Products Detected? Quantified?

Physical appearance of SRMRS
(see Raw Material control method)

Analyst who performed assay / entered results from certificate of analysis (please circle)

Name:                                              Signature:                                             Date:
Please make sure the following are attached to this form:
Completed Form-340 to show calculations and resulting Chromatograms
Manufacturers Certificate of Analysis
Copy of Raw Material Specification and Test Report showing in-house testing results.
All other summary sheets & testing results previously done on this bottle of reference
substance





Pharmacopoeia
Limits for SRMRS
BP USP EP
(Please circle)
Assay Limit &
Description

WC/LOD
Limit

This bottle of SRMRS has been APPROVED  / REJECTED (please circle) by second Analyst for use as
a Secondary Raw Material Reference Substance.

Name:                                              Signature:                                             Date:
Date bottle finished or discarded including reason
(complete when known)


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