TEST

SPECIFICATION AS PER USP

Description

Black hard gelation capsules, size “0”, containing black coloured granules.

Weight of 20 filled capsules

10.00 gm

Avg. wt. of Capsule

500 mg

Uniformity Of Weight

Within ± 7.5% Of Average Weight

Disintegration Time

NMT 30 Min In Water Medium At 37°C

Average net Content

400 ± 7.5%

Adsorptive power of Charcoal USP 260 mg

The difference between sample and blank titration is 0.7 ml.

TEST

SPECIFICATION AS PER USP

Description

A golden yellow coloured solution

Identification

Complies

pH

5.0 to 7.5

Sterility testing

Complies as per BP

Volume Variation

NLT 1.0 ml

Assay:

Each ml contains: Phytomenadione BP…..10mg

90.0% to 115.0%

• Each vial contains: piperacillin sodium USP, Eq. to piperacillin 4 g, tazobactam sodium, Eq. to tazobactam 0.5 g

• Antibacterial

• Piperacillin, a broad spectrum, semisynthetic penicillin exerts bactericidal activity by inhibition of both septum and cell wall synthesis.
• Tazobactam, a beta-lactam structurally related to penicillins, is an inhibitor of many beta- lactamases, which commonly cause resistance to penicillins and cephalosporins but it does not inhibit AmpC enzymes or metallo beta-lactamases.
• Tazobactam extends the antibiotic spectrum of Piperacillin to include many beta-lactamase- producing bacteria that have acquired resistance to Piperacillin alone.

• Yashipiptaz is used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. Yashipiptaz is indicated for the treatment of the following infections in adults and children over 2 years of age
• Adults and adolescents:
• Severe pneumonia including hospital-acquired and ventilator-associated pneumonia
• Complicated urinary tract infections (including pyelonephritis)
• Complicated intra-abdominal infections
• Complicated skin and soft tissue infections (including diabetic foot infections)
• Children 2 to 12 years of age: Complicated intra-abdominal infections

• Yashipiptaz is administered by intravenous injection (over 30 minutes). The dose and frequency of Yashipiptaz depends on the severity and localization of the infection and expected pathogens.
• Adult and adolescent patients:
• For Infections: The usual dose of 4g piperacillin /0.5g tazobactam is given every eight hours.
• For nosocomial pneumonia & bacterial infections in neutropenic patients: Recommended dose of 4g piperacillin /0.5g tazobactam is every six hours. This regimen may also be applicable to treat patients with other indicated infections when particularly severe.
• For patients on haemodialysis, one additional dose of piperacillin/tazobactam 2g/0.25g should be administered following each dialysis period. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 mL/min.
• Children: YASHIPIPTAZ is not recommended for children below 2 years age.
• Neutropenic children with fever suspected due to bacterial infections: 80mg
• Piperacillin/10mg tazobactam per kg body weight, every six hours; not to exceed the maximum 4g /0.5g per dose over 30 minutes.
• Complicated intra-abdominal infections: 100mg piperacillin/12.5mg tazobactam per kg body weight, every eight hours; not to exceed the maximum 4g/0.5g per dose over 30 minutes.
• Creatinine Clearance = 50 mg/mL: 70mg piperacillin/8.75mg tazobactam per kg body weight, every eight hours.
• For children on haemodialysis, one additional dose of 40mg piperacillin /5mg tazobactam per kg should be administered following each dialysis period.

Test

In-House Specification

Description

A clear colourless liquid with characteristic odour

pH

5.0 – 6.0

Weight per mL

1.05 g/mL ± 0.05g/mL

Net filled Volume

121.0 mL ± 1 mL

Leak Test

Must comply

Microbial Test

Total Bacterial Count

NMT 1000 CFU/mL

Total Fungal Count

NMT 100 CFU/ mL

Pathogens:

E. coli

Should be Absent in 1.0 mL

Salmonella

Should be Absent in 10.0mL

P. aeruginosa

Should be Absent in 1.0 mL

S. aureus

Should be Absent in 1.0 mL

TEST

SPECIFICATION

Description

A white coloured, round shaped flat beveled edged, uncoated tablet with break line on one side and plain on other side.

Identification:

By IR

By Melting Point

By Colour Development

Should comply as per BP

The IR absorption spectrum of the residue of sample preparation should be concordant with the reference spectrum of the paracetamol

About 169° C

A violet colour should develop which does not turn red.

Uniformity of weight

± 5% of average weight

Average Weight

560.00 mg ± 3%

Thickness

3.80 mm (± 0.2 mm)

Diameter

12.70 mm (± 0.2 mm)

Disintegration time

NMT 15 minutes

Hardness

NLT 3 kg/cm²

Friability

NMT 1.0%

Dissolution

NLT 75%

Related Substances

Must comply as per BP

Assay

95.0% to 105.0% of LA