Antibiotic Drugs

Cefuroxime Injection

Approx. Rs 500 / Pack

Strength: 1.5gm
Packaging Size: 1 vial
Manufacturer: Yashica
Brand Name: YASHIROXIME
Country of Origin: Made in India
Form: Injection

Cefuroxime injection is used to treat certain infections caused by bacteria including pneumonia and other lower respiratory tract (lung) infections; meningitis (infection of the membranes that surround the brain and spinal cord); gonorrhea (a sexually transmitted disease); and skin, blood, bone, joint, and urinary tract infections. Cefuroxime injection may also be used before, during, and sometimes for a brief period after surgery in order to prevent the patient from getting an infection. Cefuroxime injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.

Antibiotics such as cefuroxime injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

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%

NAME OF PRODUCT : YASHIAZEE (Azithromycin Tablets 250 mg)
TEST	SPECIFICATION AS PER USP
Description	A white coloured, round shaped, biconvex, film coated tablet plain on both side.
Identification (HPLC)	Should comply as pr IHS The retention time of the major peaks in the chromatogram of the assay preparation should correspond to that with the chromatogram of std preparations as obtained in the assay.
Average Weight	42745 mg ± 3%
Uniformity of weight	within ± 5% of average weight
Disintegration Time	NMT 30 min in water medium at 37?
Friability	NMT 1.0%
Assay - Each film coated tablet contains: Azithromycin Dihydrate eq to Azithromycin Base………250 mg	90.0% to 110.0%

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

Composition:	Each Pipette Contains: Fipronil : 9.8% w/w S-Methoprene : 8.8% w/w Excipients : q. s.
CATEGORY :	Ectoparasiticide
PHARMACODYNAMICS :	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.
PHARMACOKINETICS :	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%

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	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%

NAME OF PRODUCT : Clarithromycin Syrup
TEST	SPECIFICATION AS PER USP
Test	In-House Specification
Description	A White To Light Pink Coloured Strawberry Flavored Granular Powder.
Identification	Must Complies As Per USP The Retention Time Of The Major Peak Of The Sample Solution Corresponds To That Of The Standard Solution As Obtained In The Assay.
PH	4.0 – 5.4
Net Filled Volume	10.0 Gm/60 ML
Wt. Per Ml	About 1 Gm/Ml
Loss On Drying	NMT 2.0 %
Assay	Each 5 Ml Of Reconstituted Suspension Contains Clarithromycin USP……..125 Mg LIMIT: 90.0 % To 115.0% After 7 Days Clarithromycin USP……125 Mg LIMIT: 90.0 % To 115.0%

NAME OF PRODUCT : Ciprofloxacin Tablets
TEST	SPECIFICATION AS PER USP
TEST	SPECIFICATION
Description	A White Coloured, Oblong Shaped, Biconvex Film Coated Tablet With Break-Line On One Side.
Identification (HPLC):	Should Comply As Per USP 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: Each Film Coated Tablet Contains: Ciprofloxacin Hydrochloride USP Eq. To Ciprofloxacin 500mg	90.0% To 110.0% 450 Mg To 550 Mg

NAME OF PRODUCT : YASHICILLIN 500 (Ampicillin Capsules BP 500 mg)
TEST	SPECIFICATION AS PER USP
Description	A maroon/yellow coloured size 0 hard gelatin capsule containing white coloured powder.
Identification:	Should comply as per BP
1. By Colour Development 2. By TLC	A magenta-violet colour should be produced immediately. The principal spot in the chromatogram obtained with test casolution should be similar in position, colour and size with that of the chromatogram obtained with reference solution.
Average Net Content of 20 Capsules	571.00 mg ± 3.0%
Uniformity of Net Weight	Within ± 7.5% of average weight
Disintegration Time	NMT 30 min in water at 37?
Related Substances:	Should comply as per BP
Total Impurity	In the chromatogram obtained with test solution: the area of any secondary peak should not be greater than the area of the principal peak in the chromatogram obtained with test solution (2) (1%)
Assay: Each capsule contains: Ampicillin Trihydrate BP eq. to Ampicillin anhydrous 500mg	92.50% to 107.50% 462.50 mg to 537.50 mg

Cefuroxime Injection

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