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FINISHED PRODUCT SPECIFICATIONS & TESTING METHODVISOREX GEL 10g DOCUMENTS NO:

VP/SAP/090Rev NO: 00

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PRODUCTVISOREX GEL 10gram

COMPOSITION

Each gram contains:-Erythromycin---------20 mgIsotretinoin------------0.5 mg (Valor Specs.)

DESCRIPTIONSEMI-TRANSPARENT

YELLOWISHSEMI SOLID GEL

AV.WT / VOLUME Aproxi 10 g / Tube

PH6 to 8

VISCOSITY 5000-7000 CP at 25C

ASSAY LIMITErythromycin: 90-120 %Isotretinoin: 90 -110 %



METHOD OF ANALYSIS:

ASSAY OF ERYTHROMYCIN:

SAMPLE PREPARATION

Weigh gel equivalent to 20mg of erythromycin, blended for about three minutes in a high speed glass blender jar containing 200 ml of Buffer no. 3 to which has been added 0.5% of Polysorbate 80. Filter and degas, having a known concentration of about 0.1 mg per ml.

STANDARD PREPARATION:

Weigh an accurately 20mg of erythromycin (RS) blended for about three minutes in a high speed glass blender jar containing 200 ml of Buffer no. 3 to which has been added 0.5% of Polysorbate 80.Filter and degas, having a known concentration of about 0.1 mg per ml.

Organism used; Micrococcus luteus (ATCC# 9341)Method used: Well diffusion method (10mm well)Medium used: Nutrient agar Pour an equal volume of about 100 micro liter of the sample preparation and the standard preparation into the respective wells of the standards and sample prepared on the nutrient agar medium.Incubate for 24-48 hours at 37oC.Measure the zone of inhibition of the standard preparation and the sample preparation and calculate the amount of erythromycin in mg by the following formulas.

Percentage = Zone of inhibition of sample x 100 Zone of inhibition of standard

ASSAY OF ISOTRETINOIN:

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SAMPLE PREPARATION

Weigh gel equivalent to 20mg of Isotretinoin add 5 ml of methylene chloride sonicate and dissolve for 10 minutes add quantity sufficient of acidified isopropyl alcohol to make 100 ml and filter.Take 2.5ml of the filtrate and dilute to 100 ml with Isopropyl alcohol having a known concentration of about 0.005 mg/ml.

STANDARD PREPARATION:

Take an accurately weighed quantity of isotretinoin 20mg into a 100 ml of volumetric flask add 5 ml of methylene chloride sonicate and dissolve for 10 minutes add quantity sufficient of acidified isopropyl alcohol to make 100 ml and filter.Take 2.5ml of the filtrate and dilute to 100 ml with Isopropyl alcohol having a known concentration of about 0.005 mg/ml.

Measure the Absorbance of Sample and Standard solutions by using UV-Visible spectrophotometer at Lambda max 353nm.

CALCULATION:

Percentage of Isotretinoin = Absorbance of Sample X 100 Absorbance of Standard

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Author : Approved By :Senior Analyst QC Manager

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