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    Levofloxacin: Medicon Pharmaceuticals (PVT) LTD

    Uploaded by

    Mohammed Zubair
    This 3-page document provides the standard operating procedure for testing the raw material Levofloxacin used in manufacturing at MEDICON Pharmaceuticals. It details the purpose, scope, responsibilities, safety precautions, equipment, procedures, calculations, and records for analyzing Levofloxacin's characteristics such as loss on drying, sulphated ash, assay, solubility, and identification. The procedure involves chemical testing using instruments like a muffle furnace, analytical balance, hot plate stirrer, and UV-VIS spectrophotometer.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd

    Levofloxacin: Medicon Pharmaceuticals (PVT) LTD

    Uploaded by

    Mohammed Zubair
    137 views3 pages
    This 3-page document provides the standard operating procedure for testing the raw material Levofloxacin used in manufacturing at MEDICON Pharmaceuticals. It details the purpose, scope, responsibilities, safety precautions, equipment, procedures, calculations, and records for analyzing Levofloxacin's characteristics such as loss on drying, sulphated ash, assay, solubility, and identification. The procedure involves chemical testing using instruments like a muffle furnace, analytical balance, hot plate stirrer, and UV-VIS spectrophotometer.

    Original Title

    Levofloxacin (MKB Specs)

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    This 3-page document provides the standard operating procedure for testing the raw material Levofloxacin used in manufacturing at MEDICON Pharmaceuticals. It details the purpose, scope, responsibilities, safety precautions, equipment, procedures, calculations, and records for analyzing Levofloxacin's characteristics such as loss on drying, sulphated ash, assay, solubility, and identification. The procedure involves chemical testing using instruments like a muffle furnace, analytical balance, hot plate stirrer, and UV-VIS spectrophotometer.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    137 views3 pages

    Levofloxacin: Medicon Pharmaceuticals (PVT) LTD

    Uploaded by

    Mohammed Zubair
    This 3-page document provides the standard operating procedure for testing the raw material Levofloxacin used in manufacturing at MEDICON Pharmaceuticals. It details the purpose, scope, responsibilities, safety precautions, equipment, procedures, calculations, and records for analyzing Levofloxacin's characteristics such as loss on drying, sulphated ash, assay, solubility, and identification. The procedure involves chemical testing using instruments like a muffle furnace, analytical balance, hot plate stirrer, and UV-VIS spectrophotometer.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 3

    MEDICON PHARMACEUTICALS (Pvt) Ltd.

    STANDARD OPERATING PROCEDURE.


    (Not valid without signature)
    Document No MEDICON/QC/RT/019
    Effective date
    Levofloxacin Revision No 00
    Replaces Rev# - Dated: -
    Review schedule by QA/QCM with 1year 2year 3year 4year5year 6year
    Head of the Department.

    Prepared by Reviewed by Approved by

    1.0 Purpose
    This SOP covers the complete chemical testing of the Raw Material.
    2.0 Scope
    This procedure is applicable to the Raw material and vendor sample used in manufacturing of product in
    MEDICON, involving its chemical analysis as per MEDICON specification, maintaining the record, the
    instruments used and safe handling as per recommendations given in MSDS.

    3.0 Terms and Definitions


    Terms Definitions
    MSDS Material Safety Data Sheet.
    NMT Not More Than.

    4.0 Responsibilities
    a. Quality Control Manager
    i. To supervise all the activities.
    b. Quality Control Analyst
    i. To manage the analysis of product.
    ii. To check the quality records.
    iii. To look after staff and equipments.
    5.0 Environment, Safety and Health Precautions
    a. Wear disposable masks, goggles and rubber gloves.
    b. To follow the safety rules and regulation according to procedure.
    c. Store and handle the hazardous material according to procedure.
    d. Handle the spillage material according to procedure.
    6.0 Procedure
    a. Glassware
    Pipettes, China Crucible, Beaker, Test Tube, Volumetric flasks.
    Copy # Controlled document not to be duplicated
    page#1
    b. Instruments
    i. Muffle furnace ii. Analytical Balance (Sartorius). iii. Hot Plate Stirrer
    iv. Moisture Analyzer v. UV-VIS Spectrophotometer
    c. Characteristics
    Light yellow to yellow white crystalline powder.
    d. Solubility
    It is freely soluble in glacial acetic acid and chloroform; sparingly soluble in water.
    e. Identification
    UV Absorbance Maxima at 294 nm in water (10 µg /mL)
    f. Loss on drying ( NMT 4.0 % )
    When determined on 1.00 gm at 105oC for 30 minutes.
    g. Sulphated Ash ( NMT 0.1 % )
    Heat the silica or platinum crucible in the furnace according to SOP at 600 oC ± 50°C till red hot.
    Cool, and weigh (W1) on an analytical balance according to SOP. Put 1 gram sample and weigh
    (W2) on an analytical balance and heat first on a water bath, then cautiously on a flame and then
    progressively to about 600°C. Continue incineration until all black particles have disappeared and
    then allow to cool. Add few drops of H2SO4, incinerate as before and allow to cool, weigh (W 3).
    Calculation
    W3 – W1
    %age = x 100
    W2 – W1
    h. Assay ( 98.0 --- 102.0 % on anhydrous basis)
    i. Reagents
    0.1 M HCl
    Dilute 8.5 mL of concentrated HCl in volumetric flask and make up to volume 1000 mL with distilled
    water.
    Sample Solution:
    Take accurately weighed 51.25 mg sample of Levofloxacin (as hemihydrate) equivalent to 50 mg of
    Levofloxacin in 250ml volumetric flask. Add 150-160ml of 0.1 M HCl, warm & shake in ultrasonic
    bath for 15 minutes to dissolve the active ingredient completely. Cool and make volume to 250ml
    with 0.1M HCl. Filter & dilute 5ml of filtrate to 100ml with same solvent. This is final sample solution
    having known concentration of 10ug/ml.
    Standard Solution:
    Take accurately weighed 51.25 mg of Levofloxacin WS (as hemihydrate) equivalent to 50 mg of
    Levofloxacin in 250ml volumetric flask. Add 150-160ml of 0.1 M HCl, warm & shake in ultrasonic
    bath for 15 minutes to dissolve the active ingredient completely. Cool and make volume to 250ml
    with 0.1M HCl. Filter & dilute 5ml of filtrate to 100ml with same solvent. This is final standard
    solution having known concentration of 10ug/ml.
    BLANK: 0.1M HCl
    PROCEDURE:
    Measure the absorbance of final sample solution as well as final standard solution at the
    wavelength of 294nm & calculate the percentage as follows;
    CALCULATION

    Calculate the percentage of Levofloxacin as follows;


    %age of Levofloxacin = AU x WS x (100 – LS) x P x 100
    Where: AS WU (100 – LU) x 100
    AU is the absorbance of Levofloxacin in sample preparation.

    Copy # Controlled document not to be duplicated


    page#2
    AS is the absorbance of Levofloxacin in standard preparation.
    WU is the concentration in ug / mL of Levofloxacin in sample preparation.
    WS is the concentration in ug / mL of Levofloxacin in standard preparation.
    P is potency of Levofloxacin Working standard.
    LU is the moisture % of the sample.
    LS is the moisture % of the Working standard.
    Note:
    After performing the test enter the results in raw material analysis.

    7.0 References
    Description
    Analytical Balance (Sartorius).
    Hot Plate Stirrer
    Muffle Furnace
    Moisture Analyzer
    UV-VIS Spectrophotometer
    Receiving, Storage and handling of chemicals
    Safety Rule and Regulation in Quality Control Lab.
    Handling of spilled material

    8.0 Records
    Description
    Raw material Analysis Record

    9.0 History

    Revision No. Description


    00 --

    10.0 Distribution List


    The followings are in Controlled Distribution List.

    Copy No. Designation Issued To


    Copy # 01 Master Document D&RC
    Copy # 02 Quality Control manager Quality Control Department
    Copy # 03 Production Manager Production Department

    Note: In case of revision and circulation of new copy of the SOP, The obsolete copy will be returned
    to D&RC for disposition.

    Copy # Controlled document not to be duplicated


    page#3

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