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    Certificate of Analysis: Analytical Reference Substance Azithromycin Impurity M 3'-N, N-didesmethyl-N-Formyl Azithromycin

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    Elvita Sari
    This certificate of analysis provides analytical details for a reference substance called Azithromycin Impurity M. The document summarizes the identity, purity, water content, residual solvents, and potency of the substance as determined through various analytical techniques. Key findings include a purity of 97.86% as measured by HPLC, water content of 0.172%, and an overall potency of 97.68%. The substance meets quality standards for use as an analytical reference.

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    © All Rights Reserved
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    Certificate of Analysis: Analytical Reference Substance Azithromycin Impurity M 3'-N, N-didesmethyl-N-Formyl Azithromycin

    Uploaded by

    Elvita Sari
    38 views6 pages
    This certificate of analysis provides analytical details for a reference substance called Azithromycin Impurity M. The document summarizes the identity, purity, water content, residual solvents, and potency of the substance as determined through various analytical techniques. Key findings include a purity of 97.86% as measured by HPLC, water content of 0.172%, and an overall potency of 97.68%. The substance meets quality standards for use as an analytical reference.

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    Jurnal

    Original Title

    COA-AZITHROMYCIN-IMPURITY-M

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    This certificate of analysis provides analytical details for a reference substance called Azithromycin Impurity M. The document summarizes the identity, purity, water content, residual solvents, and potency of the substance as determined through various analytical techniques. Key findings include a purity of 97.86% as measured by HPLC, water content of 0.172%, and an overall potency of 97.68%. The substance meets quality standards for use as an analytical reference.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    38 views6 pages

    Certificate of Analysis: Analytical Reference Substance Azithromycin Impurity M 3'-N, N-didesmethyl-N-Formyl Azithromycin

    Uploaded by

    Elvita Sari
    This certificate of analysis provides analytical details for a reference substance called Azithromycin Impurity M. The document summarizes the identity, purity, water content, residual solvents, and potency of the substance as determined through various analytical techniques. Key findings include a purity of 97.86% as measured by HPLC, water content of 0.172%, and an overall potency of 97.68%. The substance meets quality standards for use as an analytical reference.

    Copyright:

    © All Rights Reserved
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    of 6

    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    Analytical Reference substance

    Azithromycin Impurity M

    3’-N, N-didesmethyl-N-Formyl Azithromycin

    Product Number No 11-OLY0020.13


    CAS Number: 765927-71-7 Long-term Storage: 2-8 0C
    Lot Number: AZI-M-16 Appearance: Off White Solid
    Molecular Formula: C37H68N2O13 Melting Point: N.A.
    Molecular Weight: 748.94 g/mol Purity by HPLC: 97.86%

    Manufacturing date: September-31-2016

    Re-Test Date: September-31-2018

    This certificate is valid for two years from the date of shipment
    Provided the substance is stored under the recommended conditions.

    Additional information:
    TLC Condition: (SIO2) plate Ethyl Acetate: Hexane = 6:4, (1 drop Diethyl amine) RF – 0.30
    Single Spot, visualization in UV.

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om
    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    I. Identity
    The identity of the reference substance was established by following analyses.

    Ia. 1H-NMR Spectrum


    Conditions: BRUKER 400 MHz, DMSO-d6
    The structure is confirmed with the signals of the spectrum and their interpretation

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om
    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    Ic. IR Spectrum
    Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy.
    Instrument: BRUKER Model ALPHA.

    Ib. Mass Spectrum


    Method: Agilent LC-, Model 1200 Infinity Series: Agilent MS, Model 6120

    The M+1 (749.3) of the mass spectrum is consistent with the Molecular Weight of the
    Compound 748.9 g/mol.

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om
    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    II. Purity
    The purity of the reference substance was analyzed by SHIMADZU SCL-10AVP high
    performance liquid chromatography (HPLC).

    HPLC Conditions:
    Solution A: 1.80 g/l solution of disodium hydrogen phosphate, pH adjusted to 8.9 using dilute
    phosphoric acid or dilute sodium hydroxide.
    Solution B: Methanol: Acetonitrile (250:750 V/V)

    Diluent: 1.73g/l solution of ammonium dihydrogen phosphate adjusted pH 10.0 using


    ammonia, Transfer 350ml of this solution to suitable container. Add 300 ml of acetonitrile and
    350 ml methanol. Mix well and sonicate.

    Column: Conditions: Detector: Injector:


    Gemini NX (C18) 1.0 ml/min, 210nm/UV Manual
    5 μm, 250 x 4.6 mm 0-25 min A/B 50-55 50µl
    25-30 min A/B 55-60
    30-80 min A/B 60-75
    80-92 min A/B 75-50 (v/v)

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om
    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    Relative Retention Time (RRT) Calculation – Retention Time of Impurity (RT)/Retention (RT)
    Time of API. (23.272/60.378 = 0.38)

    Results:
    Purity: 97.86 %
    Method: Azithromycin USP
    API RT: 60.378
    Observed RRT: 0.38
    Reported RRT: 0.37

    III. Water Content


    Method: TGA Thermograms, The Percent of weight loss at 80-1050C is 0.172%

    IV. Residual Solvents


    Method: 1H-NMR
    No significant amounts of residual solvents were detected (< 0.05 %).

    V. Potency
    %Potency = (Chromatographic purity – TGA Value) = (97.86-0.172) = 97.68%

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om
    ISO 9001:2015

    CERTIFICATE OF ANALYSIS

    VI. Final Result


    Total impurities (HPLC) 2.134 %
    Water Content: 0.172%
    Purity by HPLC: 97.86
    Residual solvents: < 0.05 %
    Potency: 97.68%
    Release Date: 2016-09-02

    Reviewed By Approved By

    Director of QA Managing Director

    C o rpo ra te O ffi c e : U n i t N o F / 1 0 , 1 s t F l oo r S hu b ha Pa rv ti I nd u s tri a l P re m i se s , D o mb i v a l i ( Ea s t)


    K a l y a n - Tha ne -42 12 01
    C o n ta c t C om pa n y : w w w .O l y m p u s im pu ri ti e s ta nd a rd .c o m , M o – +9 1 -75 06 25 662 5
    F o r F u rth e r En q u i ri e s : i nfo @ O l y m pu s i mp u ri tie s tand a rd .c om

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