In pharmacy, syrups are among the simplest liquid dosage forms in which a sweet taste valued for stability and taste masking is extremely important. Syrup IP ’66, as defined in the Indian Pharmacopoeia 1966, is a conventional formulation for sweetening and preserving several medicinal syrups. The experiment is a practical one explaining how to prepare the Syrup IP ’66, which helps pharmacy students get a direct idea of the role of concentration, heating, and testing for quality in syrup manufacture.

Aim: Preparation of Syrups (Syrup IP ’66)

References

1. Indian Pharmacopoeia 1966, Volume I.
2. Aulton, M. E. Pharmaceutics: The Design and Manufacture of Medicines.
3. Ansel, H. C., Allen, L. V., & Popovich, N. G. Pharmaceutical Dosage Forms and Drug Delivery Systems.

Objective

To prepare Syrup IP ’66, a pharmaceutical syrup formulation, and understand its preparation process, characteristics, and quality control parameters.

Principle

Syrup IP’66 is prepared by the dissolution of sucrose (66.7% w/vol) in purified water with soft heating for the preparation. When you heat the sucrose, you are increasing its solubilization, and therefore, a clear, homogenous solution can be obtained. This syrup provides sweetening and stabilizing effects in pharmaceutical liquid dosage forms. Good filtration will sieve out undissolved particles, and the right storage will allow the syrup to remain clear without microbial contamination.

Materials required

Chemicals Required:

• Sucrose: 66.7% w/v
• Purified Water: Quantity Sufficient (QS)

Apparatus Required:

• Beaker (1000 mL)
• Measuring cylinder
• Water bath
• Glass rod
• Thermometer
• Muslin cloth or filtration assembly

Procedure

1. Preparation of Sucrose Solution:

1. Weigh the required quantity of sucrose.
2. Heat 850 mL of purified water in a beaker in a water bath to approximately 60°C.
3. Gradually add the weighed sucrose into the warm water with continuous stirring until it is dissolved completely.

2. Adjust the Volume:

1. After the sucrose has dissolved, cool the solution slightly and add purified water to make up the volume to 1000 mL.

3. Filtration:

• Filter the solution through a muslin cloth or a filtration assembly to remove undissolved particles.

4. Storage:

• Store the prepared syrup in a clean, dry container (preferably amber-colored to protect against light) with an air-tight closure.

5. Observation and Results

• Appearance: Clear, colorless solution without particles.
• Consistency: Viscous due to the high sucrose content.
• Taste: Sweet.

Quality Control Tests

1. Clarity Test: Observe the syrup against a white and black background. It should be clear and free of particles.
2. Specific Gravity: Measure using a specific gravity bottle or hydrometer. The value should comply with IP standards (approximately 1.313 g/mL at 25°C).
3. pH Test: Measure the pH using a pH meter. It should range between 5 and 7.
4. Microbial Load Test: Check for microbial contamination using standard microbiological methods.

Discussion

• Importance of Heating: Heating facilitates the dissolution of sucrose. Excessive heating can caramelize sucrose and affect the quality of the syrup.
• Storage Considerations: Syrups should be stored in a cool, dry place to prevent microbial growth and crystallization of sucrose.

Applications

• Used as a sweetening and stabilizing agent in pharmaceutical preparations.
• Serves as a vehicle for active pharmaceutical ingredients in medicinal syrups.

Precautions

1. Ensure all glassware and containers are clean and dry before use.
2. Avoid overheating to prevent caramelization of sucrose.
3. Perform filtration properly to remove all particulate matter.

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Viva-voce questions

1. What is Syrup IP ’66 used for?
Syrup IP ’66 is commonly used as a sweetening and stabilizing base in pharmaceutical liquid preparations.

2. Why is heating necessary during syrup preparation?
Heating helps dissolve sucrose quickly and uniformly, but must be controlled to avoid caramelization.

3. What are the key quality control tests for syrup preparation?
Clarity, pH, specific gravity, and microbial load are essential quality checks for pharmaceutical syrups.

4. Can Syrup IP ’66 be used as a vehicle for APIs?
Yes, it’s often used to deliver active pharmaceutical ingredients in a palatable form.

5. Why should syrup be stored in amber-colored bottles?
Amber bottles protect the syrup from light, preventing degradation and microbial growth.