Jaimin Patel Shaishav Jogani Dhaval Patel

Dry

powder for injection are sterile, solid substance (including freeze dry materials) which are distributed in their final containers and which when shaken with prescribed volume of appropriate sterile liquid rapidly form clear and practically particle free solution or uniform suspension.

Test :
Uniformity content Uniformity of weight

Clarity of solution( not applicable to injectable suspensions)

Particulate matter Test for sterility

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

provision ) Uniformity of content Uniformity of mass Bacterial endotoxin-Pyrogens

Identification:IP-2010
IR absorption spectrophotometry HPLC

BP-2010
IR absorption spectrum TLC

USP-32
IR absorption -

Storage:IP-2010 Temperature NMT 30oc BP-2010 Use immediately after preparation USP-32 Preserve in tight containers

Tests
Appearance of solution pH Specific optical rotation N,N-Dimethylaniline Dichloromethane Heavy metals Bacterial Endotoxin

IP 2010
10% w/v solution is clear 8.0-10.0 +258o to+287o NMT 20 ppm NMT 0.2%w/w Max 20 ppm NMT 0.15 unit per mg

BP 2010
NM opalescent with reference 8.0-10.0 +258o to+287o Max 20 ppm Max 20 ppm LT 0.15 IU per mg

USP 32
8.0-10.0 +258o to+287o Meets the requirements NMT o.15 unit per mg

Cont
Tests Sterility Water Assay Related substances Crystallinity IP 2010 Complies with test NMT 2.0% By LC BP 2010 Max 2.0% By LC By LC USP 32 By membrane filtration technique NMT 2.0% By LC Meet the requirements

Ampicillin Injection
Synonym: Composition: Category: Dose: Direction: Ampicillin Sodium Injection NLT 95% and NMT 1o5% of Ampicillin Antibacterial 100mg, 250mg, 500mg and 1g Reconstitute with Water for Injection at the time of administration
FOR INJECTION USE ONLY

Identification Storage

Determine by TLC The constituted solution should be used immediately after preparation.

Tests pH Bacterial endotoxins

IP 2010 8.0-10.0 NMT 0.25 Endotoxin unit per mg of Amoxycillin NMT 3.5% By LC

Water Assay

Amoxycillin and Potassium Clavulanate Injection

Composition: Category: Dose: Direction: NLT 90% and NMT 1o7.5% of Amoxycillin Antibacterial 0.3g, 0.6g, 1.2g per 10ml Reconstitute with Water for Injection at the time of administration FOR INJECTION USE ONLY

Identification:IP-2010
TLC

BP-2010
IR absorption spectrophotometry

USP-32
By TLC

Storage:IP-2010 BP-2010 USP-32

Use immediately after preparation

In sterile airtight , tamperproof container

Preserve in containers for sterile solids

Tests
Appearance of solution pH Assay Specific optical rotation Bacterial Endotoxin Water Related substances Heavy metal

IP 2010
6.0-8.0 By LC NMT 0.15 unit per mg of cefamandole NMT 3.0% -

BP 2010
Clear solution 6.0-8.0 By LC -35 to -45 LT 0.15 IU per mg

USP 32
6.0-8.0 By LC NMT 0.15 unit per mg of cefamandole NMT 3.0% -

Max 2.0% By LC Max 20 ppm

Cefamandole Injection
Synonym: Composition: Category: Dose: Direction: Cefamandole Naftate Injection NLT 90% and NMT 115% of Cefamandole Antibacterial Equivalent of 1g, 2g, 10g of cefamandole Reconstitute with Water for Injection at the time of administration
FOR INJECTION USE ONLY