ad


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:
Thickness of cell:

Blank:

Maxima absorption wavelength

Sample:

Other reagent used:


No. of obs.
Concentration
Wavelength
Absorbance
Sample solution









Reference solution










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


No comments:

Post a Comment