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    COA. RMA. Ciprofloxacin

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    Sakib Chowdhury
    This document is a certificate of analysis for a batch of ciprofloxacin hydrochloride. It provides identification and purity test results. The batch number is 105-211003-1, with a batch size of 1126.20kg. Tests showed the product was a faintly yellowish crystalline powder, with solubility and infrared spectroscopy results meeting specified acceptance criteria. The date of manufacture was February 11, 2021.

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    COA. RMA. Ciprofloxacin

    Uploaded by

    Sakib Chowdhury
    68 views1 page
    This document is a certificate of analysis for a batch of ciprofloxacin hydrochloride. It provides identification and purity test results. The batch number is 105-211003-1, with a batch size of 1126.20kg. Tests showed the product was a faintly yellowish crystalline powder, with solubility and infrared spectroscopy results meeting specified acceptance criteria. The date of manufacture was February 11, 2021.

    Original Description:

    Ciprofloxacin HCl USP COA. Manfacturer: Zhejiang Guobang Pharma. Co. Ltd., China

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    This document is a certificate of analysis for a batch of ciprofloxacin hydrochloride. It provides identification and purity test results. The batch number is 105-211003-1, with a batch size of 1126.20kg. Tests showed the product was a faintly yellowish crystalline powder, with solubility and infrared spectroscopy results meeting specified acceptance criteria. The date of manufacture was February 11, 2021.

    Copyright:

    © All Rights Reserved
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    Flag for inappropriate content
    Download as pdf or txt
    68 views1 page

    COA. RMA. Ciprofloxacin

    Uploaded by

    Sakib Chowdhury
    This document is a certificate of analysis for a batch of ciprofloxacin hydrochloride. It provides identification and purity test results. The batch number is 105-211003-1, with a batch size of 1126.20kg. Tests showed the product was a faintly yellowish crystalline powder, with solubility and infrared spectroscopy results meeting specified acceptance criteria. The date of manufacture was February 11, 2021.

    Copyright:

    © All Rights Reserved
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    of 1

    ~

    eGXi
    wrrrIEn~~~~t!~ifJ
    ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD.
    li!!J]/:: rftmWrtt!l~ffl~J:.GiJ tt~7F2tIiI~liJ&G~ •• , 3113@ ·fUt: 086·575-82735575 li!.1f, 086·S75-8l73?3SS
    No.6, Wtiwu R,.,ad, Hau:zhou GulfShoRgYu Eeonom1e-and Tcthnnlogl.c;aI~otl,"~it Zone. ZheJiang.Chlna (312369)
    . FAl: 08G-S1S-8l73S57S1t~: .: :Q8G.~147~~~:-;",.
    *..- .6ir.:;.
    .,t.
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    CERTIFICATE
    1j)(.. - 'iF
    OF ~NAW,S1S ~j,-I.
    B.ll T,
    10
    rw
    "
    1Ii1§.~~~ (COANOJ
    t&db~~ Product
    Ts-.QCSAOOI09002-ReportO~O

    ..'
    CiprotJo~
    !lHl~:PI,I};I'.)I'I1S
    ,- -.
    H}'drochlondC'·
    of,:
    ' fi' .... .1i$
    lit. n :l\..~l-a: ~
    tm .•••' •.• 'F
    stch No.
    S~ri&INo.\A.l052110005

    105-211003·1
    _
    iY. ~ PnckDglng Size . 25kg!fifj (drum)
    ~. ...
    "-"".
    ,
    .-tRi...
    A Batch Size 1126.20Kg
    <

    1=:rx 8 Wi MFO Dnre 0211012021 (dlmJy) m~ 8 1m Reporting Date 09/1012021 (dimly)


    -
    iiI,.ff~i'ftAccordIng to USP43/IP2018 .if S 1Jj Retest Date 011101102$ (dimly)

    I £m~~ ShIPr-2<i qunntity

    .
    ;ft~l.1il§(Tests) fF*,fU!!l~(Ac~tance Criteria) ta ~(Resull$)
    I
    I
    ~~~ ~jU~1te~AU* UatliAttm*
    Falntly yellowish
    .Ap~

    1
    Faintly yellowish to IlghtyeUow Cl')'mlline powder . cryslllll" powder
    M:;tJt tE2J<op1Il1IJ.l!tilli'Z,DlII'I'
    ".az,ilJ'P1UtillU'l''I'1lli'i'li!· z
    Characters
    m_tt mt~ ~ftlz., iEBtnJ=alfl1l. Sparingly soluble In wal4; sUt1ltly
    soluble in acetic acid anrlln methanol; very slighUy soluble in ~ehydrated I
    ,
    ;
    ,
    SolubIlIty :.alcohol; pt:ICtically tlls"lublc' In atOtOl1C,1n acetonitrile,lit ethyl a~~~ in
    I ;-~ ! ' ~nna, and in ~tcn~ chloride-. ..,.,
    (1) IR.: tJ:i~1tl~tJkltUt~~m-««d!lY:Jmll-:it
    I. ~
    ",

    . i ,~~'
    . ,
    ';' IR: Con.f.orms to the ~1Nm of ::iproftoxamn aydrocllioride RS.
    ~ (2)HPWa*-ill'Ii"F.
    i ~.I'frll]-.
    .
    91;.tM.lIfttIo$11l1ll';IOJS!;;lOtl!'!!l. mil;!,
    ~~
    I Identifi~lon
    Conforins
    I :: .
    ........
    . HPLC; The ~tion time of the major peak of tho ~lc solution
    com.'5pOnds to that ofth~ Stan<brd solution. as obtaJned in the As~y .
    ,. . -(l} 0 it{t~!1!J~!tl &fil Responds to the tests for chlorido •
    -
    lit Jl~pH. 3.0-4.5 (2jm&,mI solution in water) 3.8
    7J< 1t Water 4.1.•.••6.1% 6.3%
    ~ :ff.Jalaf:~due ~nignition ~ 0.1% 0.03%
    lI~ml 'Heavy mela!s' <20ppm -<20ppm
    ijfflUt S\~ ~4.00ppm <ciOOppm
    ,
    '0 Z. Eti ~O.2%
    ,
    0.09%
    Ciorotloxacin elh"l~nediamin(' analog
    I
    ~;t;\.!fl!l!1t (HPLC) P t'-t.JliP#~ Fluorqquino!onIil
    I
    ilcirl .";0.'2% 0.07%
    Organic impurlties
    ..
    3} ~'t;"1'-1J1e!ii july, other individual ill'tpuri~ ·~O.2% 0.07%
    4) ffi:fi 1k~ ThO sum of all Impurities

    +.
    ~o.S% 0.16%

    .--
    I ~~t (HPLC}A.~ay
    I ~Hiti{~1fIJ ( "
    98.0%-( 02.00/0 of CnHisFN30J .• HCL (C\llculDt~ on the anhydtou:s ba"i~)
    ~l) z:.t.t Ethanol ~5000ppm
    99.6%
    137DPm
    I -Residual solvents ' (2iEji~ Toluene ~890ppm *tllH Notdetteted

    !6i2: *.fl,~USP43IIPZ018 ti~(tU&D&-. ~tHMt$-i!l1~


    Conclusion: Conforms to USP~311P20J 8 speclflcatlon for Ciproftoxacin Hydrochloride,

    1i-~£(note)r ;,Cln house Speclflcatfonl) ~ •• (bulkdenslty) O.4~glml .~.6! (Tapped density) O.67s1ml
    After l'isk evaluatIon' clemonta(lm urltlos moet tho \,liremonts.

    --------

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