Use our thorough Procedure for Description Appearance Test to guarantee the caliber and uniformity of your pharmaceutical products and raw materials. This crucial procedure carefully assesses your products’ visual qualities.

Description / Appearance Test for Raw Material & Drug Product

1.0     Objective

• • To describe the procedure to ascertain the description of the material in order to check the compliance with the requirements given in respective monograph/specifications on visuals basis.

2.0     Principle

• • As description is a qualitative evaluating technique and are not to be interpreter in a strict sense and are not to be regarded as official requirement.

• • It is not a standard for purity even though it may directly assist in the preliminary evaluation.

• • Where however, description is included under the heading standards the drug shall comply with the requirement. As description is part of specification all materials must comply this test.

3.0     Requirements for Description / Appearance Test:

• • Petri dish

• • Test tube

• • Butter paper

• • White tile

• • Appropriate light source (Lux level given in pharmacopoeia)

• • Beaker

• • Injection syringe

4.0     Characteristics method for Description of Raw Materials;

• • Physical property

• • Physical property of samples shall be checked by spreading the material in a petri dish observing the physical property of sample for below given characteristics; but not limited to;

• • Crystalline:

• • Material which is transmitting the light and able to be seen throughout with clarity.

• • Carry out the test as per procedure.

• • Amorphous: Having no definite form or specific shape.

• • Fine: Small-grains or smooth to the touch or having fine particles.

• • Odour:

• • Carry out the test for odour as per the procedure.

• • Taste:

• • Statements on taste are provided only in case where this is a guide to the acceptability of the material (For example, a material used primarily for flavoring). Such statements are not part of the official statements.

• • Colour:

• • The test for colour shall be checked by spreading the material in a clean butter paper in a well illuminated area and observe the colour as per respective material specification with unaided eyes.

• • The colour of the solvents shall be checked by taking the sample in as clean nessler’s cylinder.

• • If any variation found it shall be note down and reported.

• • Nature of Material:

• • Nature of the material shall be included in material description as per below examples but not limited to;

• • Hygroscopic: Material which is absorbing the moisture from atmosphere.

• • Light sensitive: Material which is sensitive to visible light and losses its colour in the presence of light.

5.0     Characteristics method for Description of Tablets/Pallets;

• • Take randomly selected adequate quantity of tablets to be examined and transfer in a clean petri dish and observe the description as per respective/relevant specification.

• • Observe the shape, edges, colour any embossing, type of dosage form and colour uniformity of a representative sample in the presence of light as per below procedure but not limited to.

• • Shape: Circular, Biconvex, Concave, Plain, Elongated, Oval and Caplet shaped.

• • Beveled Edges: Shape of bevel on boundary of tablet surface.

• • Colour: The colour of tablet/pallet shall be checked by taking the tablets/pallets in a clean petri dish in a well illuminated area and observe the colour as per respective product specifications with unaided eyes.

• • Colour Uniformity: Observe the tablet to tablet/pallet to pallet colour variation in same batch or same lot.

• • Special mark (if any): Logo, break line and embossing.

• • Specific type of dosage form: Specified the type of dosage form as per given in respective product specifications that is uncoated, film coated, sugar coated, enteric coated, chewable, effervescent, dispersible, modified release, prolonged release and soluble tablets/pallets.

• • The presence of foreign matter, black particles, sticking, chipping, capping and mottling. If any variation found it shall be note down and reported.

• • If the tablets/pallets are coated, check the coating uniformity form batch to batch and within the same bath.

6.0     Characteristics method for Description of Capsules;

• • Capsules: Take randomly selected adequate quantity of capsule to be examined and transfer in a clean petri dish and observe the description as per respective/relevant specification.

• • Observe the colour combination of cap and body colour of imprints on cap and body, self-locking, size, any dents and smudging as per below procedure but not limited to;

• • Imprints: Company logo, product name etc. on cap and body.

• • Self–locking: Capsule locking automatically when closed.

• • Size: Hard gelatin capsules size i.e. size 0, 1, 2,3,00.

• • Dents: Any holes on the capsules.

• • Open few capsules, collect the powder on a clean butter paper observed the colour and physical property of blend as per below procedure but not limited to;

• • Colour: To taking blend of capsule in a clean petri dish and observed in a well illuminated area, observe the colour as per respective product specifications with unaided eyes.

• • Physical property of filled blend

• • Granular: Material having a granular nature.

• • Fine: Small grains or smooth to the touch or having fine particles.

• • Colour and physical property of the pellets filled in description.

• • In case of soft gelatin capsules observe the colour, imprints, shape and any abnormality.

• • Open few capsules with the help of cutter or blade and record the colour and nature of the collected semi-solid mass.

• Characteristics method for Description of Dry Syrup;

• • Take out the contents from the dry syrup bottles and report the colour, physical property and nature of the powder.

• • Reconstitute as directed on the label and report colour of suspension, taste and flavor.

• Characteristics method for Description of Liquid Orals;

• • Shake and transfer the adequate quantity of liquid in clean, transparent and neutral glass test tube or beaker and check the appearance of the solution in diffused daylight, viewing horizontally against a white background which should be as per respective product specification.

• • Observe and note the description of the oral liquid preparation (clear liquid syrup, liquid syrup and liquid suspension), colour of the liquid, taste viscous and flavor of the liquid.

• • In case of finished product, also observe the type of bottled (PET/Glass bottles) colour of bottle and any  logo/Product name on PP cap (if applicable).

• Characteristics method for Description of Injections;

  • Characteristics method for Description of Liquid Injections:

• • Empty out the contents from the ampoules/vials into a clean, dry test tube.

• • Observe and record the nature, colour, clarity and presence of any foreign particles.

• • In case of finished product, also observe the type and size of containers, type, size and colour of seal and ay embossing or printing of logo on the container & sealed cap.

• Characteristics method for Description of Dry Powder Injections;

• • Empty out contents form the vials into a clean, dry petri dish and observe the nature, colour and foreign particles (if any).

• • In case of finished product, also observe the type and size of containers, type, size and colour of seal and any embossing or printing of logo on the container and sealed cap.

• Characteristics method for Description of Ointments;

• • Empty out the contents of a few collapsible tubes, bottles/jars or cartridges on a petri dish and record the apparent consistency, transparency, translucency, colour and grittiness as per below procedure but not limited to.

• • Consistency: A homogeneous uniformity of contents.

• • Transparency: The quantity of contents with respect to clarity i.e. clear and transparent.

• • Translucency: The contents quality of allowing light to pass diffusely.

• • Colour: Colour of contents.

• • Grittiness: The contents having any particles and not giving smooth texture.

• Characteristics method for Description of Eye Drops;

• • Shake and transfer the adequate quantity of contents in a clean, dry transparent and neutral glass test tube or beaker and check the appearance of the solution in diffused daylight, viewing horizontally against a white background which should be as per respective product specification.

• • Record the colour, nature (clear liquid/suspension) and presence of any suspended ingredients.

• • In case of finished product, also observe the type of filled container, colour, size and logo/Product name on cap (if applicable).

• Characteristics method for Description of Packaging Materials;

• • All packaging material description shall be checked as per respective specification for colour, type and physical appearance of materials.

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