Quality control tests for Syrups and Elixirs.

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description

for both syrups and elixirs the quality control tests are almost same. Because both are solutions.

Transcript of Quality control tests for Syrups and Elixirs.

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Topic:- Quality Control tests for Syrups And Elixirs.

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Syrup:-

“Syrups are concentrated aqueous preparations of a sugar or sugar substance with or without flavoring agents and medicinal substances.”

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Components of Syrup

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Types of syrups

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2) Non-Medicated Syrups:-

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Quality Control Tests for syrups

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 1) Clean and purified vehicle

(water):- The water is filtered and purified at the plant to destroy any micro-organisms and to remove particles from the water. Quality control technicians test the water frequently to ensure that it is clean and pure before the syrup is made. The syrup is also thoroughly filtered before filling in bottles.

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2) Light Transmittance Meter:-

A light transmittance meter is a newer tool that is used to check syrup color. In a light transmittance meter, a syrup sample is checked for color by passing light through the sample. The percent of light transmission is compared to light transmission rates set for different grades. When using one, you need to be sure there are no fingerprints on the syrup test bottle, and that the syrup sample has no bubbles or cloudiness. Any of these conditions may diminish the light that is transmitted through the sample and therefore lowers the grade of the sample.

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3) Visual Inspection:- With visual inspection, the ingredients and the final

products are carefully examined for purity and for appearance.

Physical appearance of products for patient adherence and compliance is critical so it should be

Good looking Elegance in appearance

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4) pH Measurement:-

The measurement and maintenance pH is also very important step in the Quality control testing.

Generally there are 2 different types of methods used in the measurement of pH.

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Methods for pH Measurement: The simplest and cheapest is to dip a piece of pH paper into the

sample. The paper is impregnated with chemicals that change colour and the colour may be compared to a chart supplied with the paper to give the pH of the sample.

If greater accuracy is required a pH meter should be used.  A typical pH meter consists of a special measuring  glass electrode connected to an electronic meter that measures and displays the pH reading

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5) Physical stability in syrups

The syrups are must be stable physically e.g.

its appearance (no crystallization and microbial growth)

Color must be completely soluble with other ingredients.

Odor and taste (palatable) Solid material is completely miscible in

liquid.

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6) Sucrose concentration:- The determination of sucrose concentrations is

also very important in Quality control testing of syrups.

if the concentration Sucrose in the syrup is very high it may crystallize the syrup and less sucrose concentrations give favor for the microbial growth.

There is no specific method for the determination sucrose in syrup, we use Hplc and uv-spectroscopy for this purpose.

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Ultraviolet spectroscopy can be used for quantitative analysis, by using the Beer-Lambert Law. The concentration of a single absorbing substance in a solution can be readily determined from the equation

The absorptivities of many substances at specified wavelength are available in the literature. However, if any absorptivity value in not available, it can be determined by measuring the absorbance of a solution of known concentration of the substance concerned, using the Beer-Lambert Law equation.

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The recommended procedure therefore is to make a number of absorption measurements at various concentrations of the solution, plot a graph of the absorbance's against concentrations .

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1) Determination of alcohol conc. Elixir usually contains 5 to 40% alcohol. The determination of alcohol unless otherwise specified in

the individual monograph. It is suitable for examining most fluidextracts and

tinctures and elixirs provided the capacity of the distilling flask is sufficient (commonly two to four times the volume of the liquid to be heated) and the rate of distillation is such that clear distillates are produced.

Cloudy distillates may be clarified by agitation with talc, or with calcium carbonate. And filtration is done.

After which the temperature of the filtrate is adjusted and the alcohol content determined from the specific gravity. During all manipulations, take precautions to minimize the loss of alcohol by evaporation.

For Liquids it is Presumed to Contain less than 30% of Alcohol.

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Viscosity Measurement Viscosity is a property of liquids that is directly related

to the resistance to flow. viscosity measurement is very important quality control

test in case of syrups an elixirs. viscosity and consistency directly relates with stability

of solutions.

viscosity chance of stability.

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Types of viscosity Absolute viscosity: Measure when all the specifications

and parameters are defined.

Relative viscosity: Measure when we take any standard

and make comparison.

But no decisions are made after taking relative viscosity.

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Dynamic Viscosity: The resistance to flow encountered when one

layer or plane of fluid attempts to move over another identical layer or plane of fluid at a given speed. Dynamic viscosity is also called absolute viscosity.

Kinametic viscosity: Addition and deletion of force

is known as the kinematic viscosity.

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Method 1 (U tube viscometer)

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Method II (Capillary viscometer method)

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Method III (Rotating viscometer method)

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4) Concentric cylinder viscometers

also known as absolute viscometers.

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5) Cone-plate viscometers

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 6) Spindle viscometers (relative

viscometers)

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