TEST

Limits

Description

White coloured round shaped, flat bevelled edged, uncoated tableted bisected on one end.

Identification

Mus comply as per BP

Average Weight

307.50 mg ± 5%

Uniformity of Weight

± 5.0% of average weight

Thickness

3.50 ± 0.20 mm

Friability

NMT 1.0 %

Diameter

9.50 mm ± 0.20 mm

Hardness

NLT 3.0 kg / cm²

Dissolution

NLT 70 %

Related Substances

Mus comply as per BP

Guanine

Mus comply as per BP

Disintegration Time

NMT 15 min in Purified Water

Assay

95.0% to 105.0%

TEST

SPECIFICATION

Description

A white coloured, round shaped, biconvex, film-coated tablet, bisected on one side & plain on other side.

Identification

By HPLC

Should comply as per USP

The RT of the major peak for cefixime in the chromatogram of the assay preparation should correspond to that in the chromatogram of the standard preparation as obtained in the assay.

Thickness

4.20 mm ± 0.2 mm

Diameter

9.60 mm ± 0.2 mm

Average Weight

312.73 mg ± 3.0%

Uniformity of weight

within ± 5.0% of average weight

Water

NMT 10.00%

Disintegration Time

NMT 30 minutes

Dissolution

NLT 75.0% (Q)

Assay - Each film-coated tablet contains: Cefixime USP eq to anhydrous Cefixime 200 mg

90.0% to 110.0% of Label claim

• Each Pipette Contains:
  • Fipronil : 9.8% w/w
  • S-Methoprene : 8.8% w/w
  • Excipients : q. s.

• Ectoparasiticide

• Fipronil is belonging to the family phenylpyrazole. It acts by interaction with complexes formed between the chloride channels and their ligands, especially the neurotransmitter GABA (gamma-amino butyric acid), thus blocking the transfer of chloride ions across cell membranes to levels pre and post synaptic. It thus causes uncontrolled activity on the central nervous system of insects and mites and causes their death. Fipronil kills fleas within 24 hours, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava and Haemaphysalis campanulata) and lice within 48 hours after application of the product. S-Methoprene is a regulator of insect growth (ROI) of the class of similar juvenile hormone which inhibits the development of immature stages of insects. Mimicking the action of the juvenile hormone, the compound causes impaired development and death of immature stages of fleas. The ovicidal activity of S-Methoprene applied to the dog results either from direct penetration into the shell flea eggs newly laid or its absorption through the cuticle of adult fleas. The S-Methoprene is also effective in preventing the development of larvae and pupae chip, prevents contamination of the habitat of dogs treated with the immature stages of fleas.

• Studies showed that absolute bioavailability of Fipronil was 9.5%. The Cmax was found to be 19 ng/mL in plasma found after 5 days (Tmax). Plasma concentrations were below 1ng/mL (limit of quantification) by maximum approximately 33 days following topical administration. S-Methoprene showed very low dermal absorption and all plasma concentrations were below the limit of quantification (10ng/mL).
• In Dogs, Fipronil’s major metabolite on the haircoat of the dog and in the blood stream is the sulfone derivative. Fipronil sulfone is produced on the haircoat (mean concentrations < 16% of Fpronil during the first month after treatment). S-Methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.
• In dogs after administration of the association topically, Fipronil is poorly absorbed (11%) with average maximum plasma concentration of approximately 35ng/mL for Fipronil and 55ng/mL for Fipronil sulfone.
• In dogs, the plasma Fipronil concentrations slowly reached a peak average about 101 hours and decreasing slowly (half-life) by approximately 154 hours, the highest values are observed in males. Plasma concentrations of S-Methoprene are generally below the quantification (20ng/mL) in dogs after topical administration.
• The concentrations of Fipronil, Fipronil sulfone and S-Methoprene in peeling decrease with time, but are detectable for at least 60 days after application in dogs.
• Parasites are killed mainly by contact and not by systemic exposure. No pharmacological interference between Fipronil and s-Methoprene was detected.

TEST

SPECIFICATION AS PER USP

Description

A red coloured, round shaped, convex, film coated tablet, plain on both sides.

Identification:

1. By IR

2. By TLC

A) IR- The infrared absorbtion spectrum of the residue should be concordant with the reference spectrum.

B) Shake a quantity of the powdered tablets containing 0.2 g of Metronidazole with 4 mL of 0.5M sulfuric acid and filter. To the filtrate add 10 mL of picric acid solution R1 and allow standing. The melting point of the precipitate should be measured.

C) Heat a quantity of the powdered tablets containing 10 mg of Metronidazole on a water bath with 10 mg of zinc powder, 1 mL of water and 0.25 mL of hydrochloric acid for 5 minutes, cool in ice, add 0.5 mL of sodium nitrite solution and remove the excess of nitrite with sulfamic acid. Add 0.5 mL of 2-naphthol solution and 2 mL of 5M sodium hydroxide.

Avg. Wt. Of 20 Tablets

462 mg ± 3.0%

Uniformity of Net Weight

Within ± 5% of average weight

Diameter

11.2 mm ( ± 0.1mm )

Thickness

4.7 mm ( ± 0.1mm )

Disintegration Time

NMT 30 min in water at 37°C

Related Substances:

The area of any secondary peak in chromatogram obtained with solution (2) should not be greater than area of the peak due to 2-methyl-5-nitroimidazole in the chromatogram obtained with solution (1).

Dissolution

NLT 85% (Q)

Assay: Each film coated tablet contain:

Metronidazole USP 250 mg

95% to 105%

TEST

SPECIFICATION AS PER BP

Description

A Black / Orange colored, size "2" hard gelatin capsules containing white coloured Powder.

Identification:

1. By IR

2. By TLC

Should comply as per BP

The infrared absorption spectrum obtained with test should be concordant with the reference spectrum of amoxicillin trihydrate.

The principal spot in the chromatogram obtained with test

solution should similar in position, colour and size to that in the chromatogram obtained with reference solution .

Average Net Content of 20 Capsules

290.00 mg ± 7.5%

Uniformity of Net Weight

Within ± 10% of average weight

Disintegration Time

NMT 30 min in water at 37°C

Related Substances:

Should comply as per BP

Total Impurity

In the chromatogram obtained with test solution:

The area of any secondary peak should not greater than the area of the principal peak in the chromatogram obtained with test solution (2) (1%).

Assay:

Each Hard Gelatin Capsule Contains :

Amoxycilline Trihydrate BP

Eq.to Amoxicillin anhydrous...................250 mg

92.5% TO 110%

TEST

SPECIFICATION AS PER BP

Description

A yellow coloured, oblong shaped, biconvex film coated tablet.

Identification:

1. By IR

Should comply

Average Weight of 20 Tablets

1009.41 mg ± 3%

Uniformity of weight

Within ± 5% of average weight

Height

20.10 mm ± 0.2 mm

Thickness

6.10 mm ± 0.2 mm

Disintegration Time

NMT 30 min in water at 37℃

Dissolution

NLT 70% (Q)

Uniformity of Content

85% to 115%

Assay (HPLC):

95.0% to 105.0%

Related Substances

Should comply as per BP

TESTS

SPECIFICATION

Description

A white to off white powder, highly hygroscopic

Identification

By liquid chromatography 

The retention time of principal peaks in the sample solution should correspond to the retention time of principal peaks in the chromatogram obtained with standard      solution.

pH

Between 5.0 to 7.0

Organic Impurities

Tazobactam related compound A

NMT 1.0%

Piperacillin impurity 4

NMT 1.0%

Piperacillin impurity 1

NMT 1.0%

Piperacillin impurity A

NMT 5.0%

Piperacillin impurity C

NMT 1.0%

Piperacillin impurity 5

NMT 1.0%

Piperacillin impurity 6

NMT 1.0%

Any individual unspecified impurity

NMT 1.0%

Total impurities

NMT 5.0 %

Water

NMT : 2.5 % w/w

Sterility

Should be sterile

Bacterial Endotoxins

Not more than 0.08 EU in a portion of equi. to 1 mg of a mixture of piperacillin and tazobactam

Particulate matter

i) Visual

Should be free from visible particles

ii) Light Obscuration

a) ≥ 10 µ

b) ≥ 25 µ

Not more than 6000/g

Not more than 600/g

Constituted solution

(Completeness and clarity of solution)

a) The solid should dissolve completely, leaving no visible residue as undissolved matter.

b) The constituted solution should not be significantly less clear than an equal volume of the diluents or purified water contained in similar vessel and examined similarly.

Assay

1. Piperacillin Sodium eq. to Piperacillin

2. Tazobactam Sodium eq. to Tazobactam 

 Limit :72.0 % to 88.0 %

Limit : 9.0 % to 11.0 %

TEST

SPECIFICATION

Description

A white coloured, oblong shaped, biconvex film coated tablet with break-line on one side.

Identification (HPLC):

Should comply

The principal peak obtained in the chromatogram of test solution should correspond to the peak obtained in the chromatogram of reference solution.

Average Weight of 20 Tablets

755.00 mg ± 5%

Uniformity of weight

Within ± 5% of average weight

Height

16.60 mm ± 0.1 mm

Thickness

5.80 mm ± 0.2 mm

Disintegration Time

NMT 30 min in water at 37℃

Dissolution

NLT 80% (Q)

Assay:

90.0% to 110.0%

TEST

SPECIFICATION AS PER BP

Description

An off-white coloured, oblong shaped, biconvex uncoated tablet bisected on one side.

Identification:

1. By IR

2. By TLC

Should comply as per BP

1a. IR of Sulfamethoxazole: The IR spectrum of test should be concordant with reference spectrum of Sulfamethoxazole.

1b. IR of Trimethoprim: The IR spectrum of test should be concordant with reference spectrum of Trimethoprim.

2. One of the principal spots obtained in the chromatogram with solution 1 should correspond with the chromatogram spot obtained with solution 2 and the other spot should correspond with the chromatogram spot obtained with solution 3.

Average Weight of 20 Tablets

1050.00 mg ± 5%

Uniformity of weight

Within ± 5.0% of average weight

Diameter

20.00 mm ± 0.2 mm

Thickness

5.90 mm ± 0.2 mm

Disintegration Time

NMT 15 min in water at 37℃

Friability

NMT 1.0%

Hardness

NLT 3 Kg/cm²

Assay: Each uncoated tablet -

Suphamethoxazole BP 800 mg

Trimethoprim BP 160 mg

92.5% to 107.5%

740.0 mg - 860.0 mg

148.0 mg - 172.0 mg