Scribd Logo
Upload

Welcome to Scribd!

  • 96 views

    Susp. Medifen: Product Testing Method

    Uploaded by

    Mohammed Zubair
    This document outlines the product testing method for Suspension Medifen. It contains 3 key points: 1. The product composition is defined as each 5ml containing 100mg of ibuprofen that complies with USP specifications. 2. The testing method is defined as HPLC using a mobile phase of acetonitrile and phosphoric acid run through a C-18 column at 2mL/min over 7 minutes. 3. Records of the test results will be entered and sent to QA/QC for production information and the document is controlled and distributed to quality control, production, and document control departments.

    Copyright:

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

    Susp. Medifen: Product Testing Method

    Uploaded by

    Mohammed Zubair
    96 views2 pages
    This document outlines the product testing method for Suspension Medifen. It contains 3 key points: 1. The product composition is defined as each 5ml containing 100mg of ibuprofen that complies with USP specifications. 2. The testing method is defined as HPLC using a mobile phase of acetonitrile and phosphoric acid run through a C-18 column at 2mL/min over 7 minutes. 3. Records of the test results will be entered and sent to QA/QC for production information and the document is controlled and distributed to quality control, production, and document control departments.

    Original Title

    Medifen Susp

    Copyright

    © © All Rights Reserved

    Available Formats

    DOC, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document outlines the product testing method for Suspension Medifen. It contains 3 key points: 1. The product composition is defined as each 5ml containing 100mg of ibuprofen that complies with USP specifications. 2. The testing method is defined as HPLC using a mobile phase of acetonitrile and phosphoric acid run through a C-18 column at 2mL/min over 7 minutes. 3. Records of the test results will be entered and sent to QA/QC for production information and the document is controlled and distributed to quality control, production, and document control departments.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    96 views2 pages

    Susp. Medifen: Product Testing Method

    Uploaded by

    Mohammed Zubair
    This document outlines the product testing method for Suspension Medifen. It contains 3 key points: 1. The product composition is defined as each 5ml containing 100mg of ibuprofen that complies with USP specifications. 2. The testing method is defined as HPLC using a mobile phase of acetonitrile and phosphoric acid run through a C-18 column at 2mL/min over 7 minutes. 3. Records of the test results will be entered and sent to QA/QC for production information and the document is controlled and distributed to quality control, production, and document control departments.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    You are on page 1of 2

    Document No MED/QC/PT/019

    Department Quality Control


    Effective date
    Revision No 00
    Susp. Medifen Replaces Rev# - Dated: -
    Review schedule by QA/QCM with 1year 2year 3year 4year5year 6year
    Head of the Department.
    MEDICON PHARMACEUTICALS (PVT) LTD.
    PRODUCT TESTING METHOD
    (Not valid without signature)

    Prepared by Reviewed by Approved by

    1.0 PRODUCT: Suspension Medifen


    2.0 COMPOSITION: Each 5ml contains
    Ibuprofen (USP) …………100 mg
    Product Complies USP Specifications
    3.0 METHOD: HPLC
    Mobile Phase (500ml):
    200ml acetonitrile +300ml 0.01M Phosphoric acid/500ml solution & filter it through 0.2um and sonicate it.
    Sample Solution:
    Take 100mg or 5ml Ibuprofen suspension (with help of weight / ml) and dilute in 30ml acetonitrile. Again add 10ml
    acetonitrile and 10ml of 0.01M orthrophoshoric acid shake it. Then dilute up to 100ml with 0.01N orthrophoshoric
    acid. Filter the solution through filter paper # 42 then with 0.45um filter.
    Standard Solution:
    Take 100mg Ibuprofen WS in 40ml acetonitrile and mix well. Then dilute up to 100ml with 0.01N orthrophoshoric
    acid and filter through 0.45um.
    0.01M orthrophoshoric acid:
    0.67ml Approx (0.7 ml) Phosphoric acid (85 %) to 1000ml distilled water.
    Chromatographic Conditions:
    Column: C – 18, 250 x 4.6 mm Flow rate: 2 mL/min
    Wavelength: 220 nm Injection Vol: 50 uL
    Injection Loop: 20 µL R.Time: 7 mins (Approx)

    Copy # Controlled document not to be duplicated page# 1


    Calculation:
    %age = Avg. Peak area of final sample solution x Standard Conc x 100
    Avg. Peak area of final standard solution Sample Conc

    Note: After performing the test enter the results in intimation to QA/QC for Test / Analysis, for Production
    information.
    4.0 References

    Description
    Analytical Balance
    HPLC
    Ultrasonic bath
    Receiving, Storage and handling of chemicals
    Safety Rule and Regulation in Quality Control Lab.
    Handling of Spilled Material

    5.0 Records

    Document No. Description


    MEDICON/PD/QF/011 Intimation to QA/QC for Test / Analysis

    6.0 History

    Revision No. Description


    00 --

    7.0 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# 2

    You might also like