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    The document outlines specifications for water used for injection, including chemical and microbiological analyses. Chemically, the water should be colorless, odorless, tasteless liquid with a pH between 5-8 and limits on conductivity, ammonium, calcium, chlorides, sulfates, total organic carbon, and carbon dioxide. Microbiologically, the water cannot contain more than 10 colony forming units per 100 mL for total aerobic microbial count or more than 0.125 endotoxin units per mL.

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    The document outlines specifications for water used for injection, including chemical and microbiological analyses. Chemically, the water should be colorless, odorless, tasteless liquid with a pH between 5-8 and limits on conductivity, ammonium, calcium, chlorides, sulfates, total organic carbon, and carbon dioxide. Microbiologically, the water cannot contain more than 10 colony forming units per 100 mL for total aerobic microbial count or more than 0.125 endotoxin units per mL.

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    © All Rights Reserved
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    2 views18 pages

    Screenshot 1

    Uploaded by

    satheeshk.femtosoft
    The document outlines specifications for water used for injection, including chemical and microbiological analyses. Chemically, the water should be colorless, odorless, tasteless liquid with a pH between 5-8 and limits on conductivity, ammonium, calcium, chlorides, sulfates, total organic carbon, and carbon dioxide. Microbiologically, the water cannot contain more than 10 colony forming units per 100 mL for total aerobic microbial count or more than 0.125 endotoxin units per mL.

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    of 18

    • s peciflcatic ns of water f,o r �ject i,on:

    STP/ GTP
    S. No. Tes Paran1e er Sp e:cjfI ca don
    code
    A. Chemical Anarysis
    aea r colourlessl
    1. Desaiptlon o dour!e ss a rid tasteless
    Jiquld
    2� pH (at 25 ° () Betvveen 5.0 to 8.0
    3. Cone uct.iviry (ar 25 ° [) N 1.3 µS / cm
    4. Ammonium Nfi.IT 0.3 ppm
    5. Calcjum No turbid tty observed
    6. Ch]orides NMT 0.50 ppn1
    7. SulphBies No turbid fcy o bsen..-ed
    8. Total Organic Carbon MT50CJ ppb
    The sotution remarn
    �L Oxid[sabJe Subsrar1ce
    fainrly pink
    The solution st, o u!d
    HJ. Carbon Dioxide
    remain dear
    B. Microbiological Ainalysis
    N fv1T 1 0 cfu / 1 00 m r
    , Total Aerobic Microbial
    Count (TAJ!AC)

    2. Bacterial Endotoxin TeSI N�IT 0.12.5 EU/ nil

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