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Homoeopathic medicines are widely used across the world, with globules being the most common form of medication carriers. These tiny, sugar-based bead-like preparations play a crucial role in delivering homoeopathic treatments. To ensure the consistency, purity, and quality of these globules, the Bureau of Indian Standards (BIS) has developed IS 18947– Globules for Use in Homoeopathy — Specification.

What Are Homoeopathic Globules?

Globules, also known as pellets or pillules, are small, solid spheres made of pure pharma-grade sucrose. These inert, white, odourless spheres are manufactured in a non-medicated form and later impregnated with liquid homoeopathic medicines for sublingual or oral use.

IS 18947 exclusively covers globules made of pure sucrose and does not include those containing lactose.

Key Aspects Covered in IS 18947

1. Physical and Chemical Requirements

The standard defines essential parameters to maintain the quality and uniformity of globules, such as:

• Appearance – White, uniform, and regular spherical shape.
• Size Categories – Ranges from very small (0.9 mm, or size no. 10) to large (6.6 mm, or size no. 60), ensuring uniformity across different sizes.
• Solubility – Completely soluble in water but insoluble in alcohol.
• pH – Should be between 5 and 7 to ensure stability.
• Optical Rotation – Must be between +66.3 to +67.0, confirming the purity of sucrose.

2. Stringent Testing Methods

To prevent adulteration and contamination, the standard includes several tests:

• Uniformity of Mass – Ensures each globule is consistent in weight and size.
• Impurities Check – Globules must be free from foreign substances like kaolin, chalk, talc, starch, and synthetic whitening agents.
• Porosity Test – Determines the absorption rate of homoeopathic medicine. Impregnation should not take more than 50 seconds.
• Microbial Contamination Test – Limits the presence of bacteria, yeast, and mould to prevent health risks.

3. Specialized Identification and Impurity Tests

Homoeopathic globules must be pure sucrose without any additional substances. To confirm this, the standard outlines specific tests:

• ?Kaolin Test – No white precipitate should form in a dilute ammonia solution.
• Chalk Test – No reaction should occur with dilute ammonia oxalate.
• Talc Test – No effervescence should be observed with dilute hydrochloric acid.
• Starch Test – When iodine is added, the solution should not turn blue (indicating no starch presence).

These tests help identify and eliminate adulterants that could impact the effectiveness of homoeopathic treatments.

4. Impregnation & Uniformity Tests

One of the most critical aspects of homoeopathic globules is how well they absorb and retain medication. IS 18947 prescribes two precise test methods:

• Methylene Blue Test – Measures how uniformly a test solution spreads within the globules.
• Caffeine Impregnation Test – Uses caffeine to analyze absorption levels and consistency across multiple globules.

Globules must have less than 10% deviation in impregnation levels to ensure proper medicine distribution.

5. Packaging, Storage, and Shelf Life

To maintain quality, the standard defines strict packaging and storage requirements:

• Packaging – Globules must be packed in air-tight containers made of food-safe polyethylene.
• Storage – Store in a cool, dry place to prevent moisture absorption.
• Shelf Life – Recommended to be three years, based on stability studies.

Why IS 18947 Matters?

With this standard in place, manufacturers, researchers, and homoeopathic practitioners can trust the quality of globules used in medicine preparation. It ensures:

• Consistency – Standardized size, weight, and mass for accurate medicine dosing.
• Purity – Free from foreign matter and microbial contamination.
• Efficacy – Proper absorption and retention of homoeopathic medicines.

This initiative by BIS is a significant step toward ensuring safer and more reliable homoeopathic treatments.

The adoption of IS 18947 brings uniformity, purity, and reliability to homoeopathic globules. With well-defined specifications, testing procedures, and storage guidelines, this standard plays a crucial role in enhancing the quality and effectiveness of homoeopathic medicines.