TEST

SPECIFICATION

Description

Clear Colourless Aqueous Solution Filled In Amber Type I Glass Ampoule Having Blue Dot On Neck With Paper Label And Sealed

Identification

Complies 

Average Volume Of 10 Containers

NMT 1.0 Ml

Colour And Clarity Of Solution

Should Be Clear And Colourless Aqueous Solution

Particulate Matter

Should be free from particulate matter

Sterility Test

To Be Sterile

TEST

SPECIFICATION AS PER BP

Description

A yellow coloured round shaped, film coated tablets with plain on both sides.

Identification

1. HPLC

2. UV

Must comply as per USP

The retention time of the major peak of the sample solution should correspond to that of the standard solution as obtained in the assay.

The reference solution and test solution should give maxima at the same wavelength.

Thickness

5.40 mm ± 0.2 mm

Diameter

11.20 mm ± 0.2 mm

Average Weight

515.00 mg ± 5%

Uniformity of weight

within ± 5% of average weight

Disintegration Time

NMT 30 min in water medium at 37°C

Assay - Each film coated tablet contains: Mefloquine Hydrochloride USP eq. to Mefloquine 250 mg

90.0% to 110.0%

Uses

It is used for the prevention and treatment of uncomplicated malaria.

Doses Administration:

It is generally recommended that chemoprophylaxis for travelers should be started about one or two weeks before exposure to malaria, but if this is not possible, it can be started 1 to 2 days prior to travel. The administration should continue throughout exposure and for at least 4 weeks after leaving the malarious area.

Prevention Of Malaria:

Adults: 200 mg [2 tablets daily]

Children: Up to 1 Year: 25 mg [¼ tablet daily] 1 to 4 Years: 50 mg [½ tablet]

5 to 8 Years: 100 mg [1 tablet daily] 9 to 15 Years: 150 mg[1½ tablets daily]

To be taken with or after food. For children, may be crushed and mixed with milk, honey or jam.

Contraindications Warnings:

Should be used with caution in patients with renal impairment; dosage should be reduced accordingly. It is contraindicated in patients with known allergy or any of the excipients used.

Advertised Effects:

Apart from mild gastric intolerance, diarrhea and some reports of aphthous ulceration there appear to be few adverse effects associated with usual doses of Proguanil hydrochloride. Haematological changes may occur in patients with severe renal impairment.

Interactions:

Fluvoxamine can virtually abolish the metabolism of Proguanil to its active metabolite cycloguanil via an inhibitory effect on the cytochrome P450 isoenzyme CYP2C19.

Test

Specification

Description

White circular flat bevelled edged uncoated tablet having breakline on one side

Identification (By IR)

Should Comply

Disintegration Time

NMT 15 minutes

Related Substances (HPLC)

Should Comply

Average Wt.

0.1924 gm

Dissolution

NLT 70 %

Assay

95.0 % to 105.0 %

Total aerobic microbial Count

NMT 1000 CFU/g

Total Yeasts and Moulds Count

NMT 100 CFU/g

E. coli

Should be Absent in 1.0 g

TEST

Limits (Adult)

Limits (Ped)

Description

White coloured round shaped, biconvex, uncoated tableted

Identification

Must comply

Average Weight

190.0 mg ± 5%

180.0 mg ± 5%

Uniformity of Wt.

± 7.5 % of average weight

Thickness

3.60 ± 0.20 mm

3.50 ± 0.20 mm

Friability

NMT 1.0 %

Diameter

8.0 mm ± 0.20 mm

Hardness

NLT 3.0 kg / cm²

Disintegration Time

NMT 15 min in Purified Water

Assay

90.0% to 110.0%

TEST

Limits

Description

White coloured round shaped, flat, uncoated tableted

Identification

Must comply

Average Weight

635.0 mg ± 5%

Uniformity of Wt.

± 7.5 % of average weight

Thickness

4.00 ± 0.20 mm

Friability

NMT 1.0 %

Diameter

12.0 mm ± 0.20 mm

Hardness

NLT 3.0 kg / cm²

Disintegration Time

NMT 15 min in Purified Water

Assay

90.0% to 110.0%