Pharmaceutical gelatin is the material that every empty hard gelatin capsule is made from. It is a purified protein, produced to a pharmacopoeia standard, that forms a strong, clear film when it dries and dissolves quickly at body temperature. This guide explains where it comes from, how its grades differ and what to look for when you buy capsules made from it.
The short answer
Pharmaceutical gelatin is a high-purity protein made from the collagen in animal bones and hides. It meets pharmacopoeia limits for purity, microbes and heavy metals. Capsule makers choose it for its gel strength (bloom), viscosity and clean dissolution in the stomach.
Where pharmaceutical gelatin comes from
Gelatin is made by partially breaking down collagen, the main structural protein in skin, bones and connective tissue. The raw material is cleaned, treated, extracted with hot water, filtered, sterilised and dried into granules. Pharmaceutical grade differs from food grade mainly in how tightly the process and the finished material are controlled and tested.
- Type A gelatin is produced by an acid process, most often from pig skin.
- Type B gelatin is produced by an alkaline (lime) process, usually from bovine bones and hides.
Hard capsule manufacturers often use bone gelatin or a blend of bone and hide gelatin to get the right balance of strength and flexibility.
Key properties for capsule making
| Property | What it means | Why it matters |
|---|---|---|
| Bloom strength | Gel firmness, measured in bloom grams | Higher bloom gives stronger shells; hard capsules typically use high-bloom gelatin |
| Viscosity | How thick the gelatin solution is | Controls how evenly the film forms on the moulding pins and the wall thickness |
| Clarity and colour | How clear the dried film is | Allows true, consistent shades for transparent and coloured capsules |
| Microbial quality | Total count and absence of pathogens | Required for a medicine container that touches the drug |
| Heavy metals and ash | Limits on impurities | Pharmacopoeia compliance and patient safety |
Pharmacopoeia standards
Pharmaceutical gelatin is tested against monographs in the major pharmacopoeias, such as the USP, BP, EP and IP. These set limits for identification, pH, loss on drying, ash, heavy metals, sulphur dioxide, peroxides and microbial contamination. Bovine gelatin should also come from a TSE/BSE-safe source, supported by the supplier's documentation.
Why gelatin works so well for capsules
- It forms a strong, glossy film that holds its shape on high-speed filling machines.
- It dissolves at body temperature in the stomach, releasing the contents quickly.
- It takes colours and printing well, so brands can create distinctive capsules.
- It has a long record of safe use in medicines and supplements worldwide.
What to check when buying gelatin capsules
- Pharmaceutical-grade, TSE/BSE-free gelatin, with certificates available.
- Halal and Kosher certification of the gelatin if your market needs it.
- A certificate of analysis for every batch. See how to read a certificate of analysis.
- Moisture in range (usually 13 to 16 percent) and correct storage. See how to store empty capsules.
Universe Capsules manufactures empty hard gelatin capsules under WHO-GMP norms, using pharmaceutical-grade, TSE/BSE-free gelatin that is Kosher and Halal certified. Read more about why to choose hard gelatin capsules.
Frequently asked questions
Is pharmaceutical gelatin the same as food gelatin?
Both come from collagen, but pharmaceutical gelatin is made and tested to stricter pharmacopoeia limits for purity and microbial quality.
What is bloom strength?
A measure of gel firmness. Higher bloom means a stronger gel, which helps capsule shells stay tough during filling and transport.
Is gelatin in capsules safe?
Yes. Pharmaceutical gelatin has a long history of safe use and is tested to pharmacopoeia standards before it is used for capsules.
Can gelatin capsules be Halal?
Yes, when the gelatin is from a Halal-certified source. Ask your supplier for the certificate.
Need gelatin capsules made to specification?
Tell us your size, colour and quantity and we will send a quotation and our specification.
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