jaimin patel

8/3/2019 JAIMIN PATEL

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Jaimin PatelShaishav Jogani

Dhaval Patel


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Dry powder for injection are sterile, solid

substance (including freeze dry materials)which are distributed in their final containersand which when shaken with prescribed

volume of appropriate sterile liquid rapidlyform clear and practically particle freesolution or uniform suspension.


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Test : Uniformity content

Uniformity of weight

Clarity of solution( not applicable to injectable suspensions)

Particulate matter

Test for sterility


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Test: Uniformity of dosage units( Herbal drugs not subjected to this

provision ) Uniformity of content

Uniformity of mass

Bacterial endotoxin-Pyrogens


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Identification:-IP-2010 BP-2010 USP-32

IR absorptionspectrophotometry

IR absorption spectrum IR absorption

HPLC TLC -

Storage:-

IP-2010 BP-2010 USP-32

Temperature NMT 30oc Use immediately afterpreparation

Preserve in tightcontainers


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Tests IP 2010 BP 2010 USP 32 Appearance of solution 10% w/v solution is

clearNM opalescentwith reference

-

pH 8.0-10.0 8.0-10.0 8.0-10.0

Specific optical rotation +258o to+287o +258o to+287o +258o to+287o

N,N-Dimethylaniline NMT 20 ppm Max 20 ppm Meets therequirements

Dichloromethane NMT 0.2%w/w - -

Heavy metals Max 20 ppm Max 20 ppm -

Bacterial Endotoxin NMT 0.15 unit permg

LT 0.15 IU permg

NMT o.15 unitper mg


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Cont

Tests IP 2010 BP 2010 USP 32Sterility Complies with test - By membrane

filtration technique

Water NMT 2.0% Max 2.0% NMT 2.0%

Assay By LC By LC By LC

Related substances - By LC -

Crystallinity - - Meet the requirements


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Ampicillin InjectionSynonym: Ampicillin Sodium InjectionComposition: NLT 95% and NMT 1o5% of AmpicillinCategory: AntibacterialDose: 100mg, 250mg, 500mg and 1g

Direction: Reconstitute with Water for Injection atthe time of administration

FOR INJECTION USE ONLY


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Identification Determine by TLC

Storage The constituted solutionshould be used immediately

after preparation.


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Tests IP 2010

pH 8.0-10.0

Bacterial endotoxins NMT 0.25 Endotoxin unit permg of Amoxycillin

Water NMT 3.5%

Assay By LC


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Amoxycillin and PotassiumClavulanate Injection

Composition: NLT 90% and NMT 1o7.5% of AmoxycillinCategory: Antibacterial

Dose: 0.3g, 0.6g, 1.2g per 10mlDirection: Reconstitute with Water for Injection at

the time of administration



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Identification:-IP-2010 BP-2010 USP-32

TLC IR absorptionspectrophotometry

By TLC

Storage:-

IP-2010 BP-2010 USP-32

Use immediately afterpreparation

In sterile airtight ,tamperproof container

Preserve in containersfor sterile solids


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Tests IP 2010 BP 2010 USP 32Appearance of

solution- Clear solution -

pH 6.0-8.0 6.0-8.0 6.0-8.0 Assay By LC By LC By LC

Specific opticalrotation

- -35 to -45 -

Bacterial

Endotoxin

NMT 0.15 unit per

mg of cefamandole

LT 0.15 IU per mg NMT 0.15 unit per

mg ofcefamandole

Water NMT 3.0% Max 2.0% NMT 3.0%

Relatedsubstances

- By LC -

Heavy metal - Max 20 ppm -


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Cefamandole InjectionSynonym: Cefamandole Naftate InjectionComposition: NLT 90% and NMT 115% of CefamandoleCategory: AntibacterialDose: Equivalent of 1g, 2g, 10g of cefamandole

Direction: Reconstitute with Water for Injection atthe time of administration


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