ETHIONAMIDE USP SOP
1.0 OBJECTIVE:
To
lay down a procedure for the active raw material of the Ethionamide USP from the Pharmacopoeial specifications.
2.0 SCOPE:
This
SOP shall be applicable in Q.C laboratory.
3.0 RESPONSIBILITY:
3.1
Q.C Analyst.
4.0 ACCOUNTABILITY:
4.1
Q.C Manager.
5.0 PROCEDURE:
5.1 Assay:
5.1.1
Apparatus:
5.1.1.1
Glassware
(according to requirement).
5.1.1.2
UV/VIS
Spectrophotometer.
5.1.1.3
Magnetic stirrer.
5.1.1.4
Analytical
weighing balance.
5.1.1.5
USP Ethionamide RS.
5.1.1.6
Methanol.
5.1.1.7
Ethionamide.
5.1.2
Standard
solution:
5.1.2.1 Prepare
10µg/ml of USP Ethionamide RS in methanol.
5.1.3
Sample
solution:
5.1.3.1 Prepare
10µg/ml of ethionamide in methanol.
5.1.4
Instrumental
conditions:
5.1.4.1 Mode: UV.
5.1.4.2 Analytical
wavelength: 290nm.
5.1.4.3 Cell:
1cm.
5.1.4.4 Blank: Methanol.
5.1.5
Analysis:
5.1.5.1 Samples: Standard solution
and sample solution.
5.1.5.2 Operate
UV/VIS Spectrophotometer according to SOP.
5.1.5.3 Note
down observations in Annexure-1.
5.1.5.4 Calculate
the percentage of ethionamide (C8H10N2S) in
the portion of ethionamide taken:
Result=
(AU/AS) × (CS/CU) × 100
AU = absorbance of the
sample solution.
AS = absorbance
of the standard solution.
CS = concentration
of USP Ethionamide RS in the standard solution (µg/ml).
CU = nominal concentration
of ethionamide in the sample solution (µg/ml).
5.1.6
Acceptance
criteria:
5.1.6.1 98.0%-102.0%
on the anhydrous basis.
6.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New SOP
|
7.0 REFERENCES:
7.1
USP38NF33
Volume-4 Official Monograph/ Ethionamide: 2015, pp.: 3410-3411.
8.0 ANNEXURES:
Annexure 1: Observations
and calculations of UV/VIS spectrophotometer.
Annexure:
1
Observations
and calculations of UV/VIS spectrophotometer
|
UV/VIS spectrophotometer
Model:
_____________________________ Date:
_________________
OBSERVATIONS:
CALCULATIONS:
By
using formulas:
Result= (AU/AS) × (CS/CU)
× 100
Results:
_______________
Remarks:
______________________________________________________________
|
9.0 ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard
operating procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
QCA
|
Quality
control active ingredient
|
|
F
|
Format
|
|
Q.C
|
Quality
control
|
|
Vol
|
Volume
|
|
g
|
Grams
|
|
ml
|
Milliliter
|
|
oC
|
Degree
centigrade
|
|
mg
|
Milligram
|
|
%
|
Percentage
|
|
USP
|
United
states pharmacopoeia
|
|
NF
|
National
formulary
|
|
λ
|
Lambda
|
|
nm
|
Nanometer
|
|
µg/ml
|
Microgram
per liter
|
|
cm
|
Centimeter
|
|
UV/VIS
|
Ultraviolet/
visible
|