Organoleptic Analysis

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

4.00 Definitions 
 
 Ay 1 Organoleptic = being, affecting, or relating to qualities (as taste, color, odor, and feel)
 
 ofa substance that stimulate the sense organs. 
 422 @€=-@u 
 ality Control 
 433 MSDS - 
 Material Safety Data Sheet 
 
 500 References 
 5 1 Merck Index 
 
 22 United States Phanmacopeia 
 
 §:3 D-901-F1: Raw Material Test Ticket 
 
 Hid p-40l-F2-FXXX: Finished Product Test Ticket 
 
 535 D-722-Fi::Organolepiticlitentiffcation TBstiingResultss 
 
 
 

[SOP 

 Standard Operating Proced ure SOP No Rev Page 2 of 2 
 Organoleptic Analysis 
 D-722 4 
 
 6.0 Procedure 
 
 611 Uncommon raw matiztidis that may requiie organdigttic as A componant Of the
 identification process must have @ sufficient descijption for identification on the
 associated raw material test ticket (D-90I-4A}), finished product test ticket (D-401) or
 Product Profile. 
 
 61111 For matezidis that do mot have organdkppttic specications set, physical
 desoriptions may be found in resources sudn as the USP, Merck index or other
 referemce.. 
 
 &22 
 When safety speiftcations are unknown for the material being tested it is recommended
 that the MSDS be reviewed for each material prior to opening and testing the material.
 33 The test begins by first looking at the material within the sample container. If sample
 container is not clear or the nature of the test requires that the sample be removed, be
 sure that the removal is done safelly (i.e. use protective equipment for strong smelling
 raw materials or corrosive materials). The material must match the visual descriptiom on
 
 the test ticket or product profile before proceeding. 
 4 If required, smell the samples by opening the container away from the nose and waft the
 
 aroma using gemtle hand movements. The sample must be free of objectionable odors
 not charactteiisiic Of the matexibl. It may have a charactenitiic odtor that cam be
 confinmed. 
 635 Taste samples only if taste is a spauified characteristic and the sample is known to be
 
 safe as per the MSDS. The sample must be free of objectionable tastes not characteristic
 ofitre material. It may have a characteristic taste that can be confinmed.
 666 Record organoleptic results onto D-722- 1 if results are not recorded elsewthee..
 
 7.0 Revision History 
 Revision -Date Desaription of Changss CCR # By_ 
 6 O120*2 | New - - 
 Changed SOP format and title, changes in Section 1.0, 2.0, 3.0: .
 nanan Added finished products in section |.0, 2.0, 5.i. ia B: sant 
 New SOP format. Adjusted organoleptic to be a supporting ID test,
 2 02166415 | nota primary ID test. Expanded desoriptions. Added references D- t5-0%42 B. Johns
 401-F2 and D-901-F1. 
 Revised scope to include all raw materials and finished product
 ? O| OBI | manufactmsel at lon Labs. oS NeZieng 
 4 @4/t4/20 | Added safety considerations and updated responsibilitizs CE200L72 | J. Maignan