Hard Capsule Gelatin
Consistent Gelatin for Empty Hard Capsule Shell Production
Xushang Gelatin Co., Ltd. manufactures and supplies gelatin developed for the production of two-piece hard capsule shells.
Our hard capsule gelatin is selected and controlled for gel strength, viscosity, film-forming performance, clarity, capsule-shell strength, drying behavior and batch-to-batch consistency.
It can be evaluated for the production of empty capsules used to contain pharmaceutical powders, granules, pellets, nutraceutical ingredients and other technically compatible fill materials.
With a 37,000 m² manufacturing facility, annual production capacity exceeding 20,000 metric tons and products supplied to more than 30 countries and regions, Xushang Gelatin provides stable bulk supply, batch inspection and export-supporting documentation for international customers.
What Is Hard Capsule Gelatin?
Hard capsule gelatin is a specially selected gelatin grade used to manufacture two-piece empty capsule shells consisting of a body and a cap.
In a typical capsule-manufacturing process, stainless-steel mold pins are dipped into a temperature-controlled gelatin solution. A uniform gelatin film forms on the pins, after which the shells are dried, removed, trimmed and joined to form complete empty capsules.
The gelatin solution must maintain suitable viscosity and temperature stability during production. The dried shell must also provide sufficient mechanical strength, flexibility, dimensional stability and disintegration performance.
Main Applications
Pharmaceutical Empty Capsules
Suitable for the production of empty hard gelatin capsules used for technically compatible pharmaceutical powders, granules and pellet formulations.
Nutraceutical Capsules
Can be evaluated for vitamins, minerals, amino acids, botanical extracts and other dry dietary-supplement formulations.
Herbal Capsules
Suitable for compatible herbal powders, plant extracts and granulated botanical formulations.
Pellet and Granule Capsules
Hard gelatin capsules can be used for multiparticulate dosage systems containing pellets, coated particles or granules, subject to formulation and stability requirements.
Contract Capsule Manufacturing
Suitable for empty-capsule manufacturers, pharmaceutical contract manufacturers and private-label nutraceutical producers requiring consistent gelatin supply.
Veterinary Capsules
Can be evaluated for appropriate veterinary capsule applications where the applicable product specification and regulatory requirements are confirmed.
Key Performance Characteristics
Controlled Gel Strength
Suitable gel strength contributes to capsule-shell strength, shape retention and resistance to deformation during production, transport and filling.
Stable Viscosity
Consistent viscosity helps control the thickness and uniformity of the gelatin film formed during the dipping process.
Uniform Film Formation
The gelatin should form a continuous and even film on the mold pins under properly controlled dipping conditions.
Good Clarity and Appearance
Controlled filtration, purification and production conditions help produce gelatin suitable for clear, translucent or colored capsule shells.
Reliable Drying Performance
Balanced drying behavior supports efficient moisture removal while reducing the risk of uneven shells, deformation or excessive brittleness.
Mechanical Strength
The finished capsule shell should withstand normal handling, separation, filling, closing, packaging and transportation.
Suitable Flexibility
A properly conditioned capsule shell should maintain sufficient flexibility and should not become excessively brittle under the specified storage conditions.
Batch-to-Batch Consistency
Stable gel strength, viscosity, particle size and moisture help capsule manufacturers maintain consistent production parameters between batches.
Typical Product Specification
The following table provides a general specification framework for hard capsule gelatin.
Final numerical limits must be based on the agreed product grade, analytical method, applicable standard and batch Certificate of Analysis.
Gel strength and viscosity results can vary according to solution concentration, testing temperature, instrument and analytical method. The test method must therefore be confirmed together with the numerical specification.
Inspection Items | Inspection Standard | Value | ||
Smell | 1.Color: Light yellow to yellow 2.State: Solid 3.Odor: Without any unpleasant odor | Yellow solid, without any unpleasant odor | ||
Identification Test | 1.Prepare 120 ml of a 6.67% gelatin solution. After cooling it to 30 °C, cover it. Then, cool it in a low-temperature bath at 10 ± 1 °C for 16 to 18 hours. The sample should turn into a gel-like state, and it can be turned back into a solution after heating. | It is in a gel state, and it can be reformed into a solution after heating. | ||
2.Add a few drops of potassium chromate test solution - dilute hydrochloric acid (4:1), and an orange - yellow flocculent precipitate will be produced.
| There is an orange - yellow flocculent precipitate produced. | |||
3.Add a few drops of tannic acid test solution, and turbidity will occur immediately.
| There is turbidity occurring. | |||
Viscosity（6.67%,60℃） mpa.s | Customer Requirements | 4.0 | ||
Gel strength（6.67%）/(Bloom g) | ≥50 | 220 | ||
Transparency/mm | Customer Requirements | 500 | ||
Transmittance |
Wavelength/nm
| 450 | ≥30 | 85.6 |
620 | ≥50 | 97.8 | ||
Ash，w/% | ≤2.0 | 0.1 | ||
SO2/(mg/kg) | ≤30 | 20 | ||
Peroxide/(mg/kg) | ≤10 | No color development | ||
Water，w/% | ≤14.0 | 11.1 | ||
Cr/(mg/kg) | ≤2.0 | 0.5 | ||
Pb/(mg/kg) | ≤1.5 | 〈1.5 | ||
Total number of colonies/(CFU/g) | ≤10000 | 〈10 | ||
Coliform group/ (MPN/g) | ≤3 | 〈3 | ||
Salmonella | Shall not be detected | No detected | ||
As/(mg/kg) | ≤1.0 | 〈1.0 | ||
Water - insoluble matter，w/% | ≤0.2 | 0.06 | ||
Conclusion | This product has been tested for the above items in accordance with GB 6783-2013 and the customer's requirements, and the results meet the specified standards. | |||
Hard Capsule Manufacturing Process
A typical hard gelatin capsule production process includes the following stages:
1. Gelatin Solution Preparation
Gelatin is hydrated and dissolved in purified water under controlled temperature and mixing conditions.
Colorants, opacifying agents or other permitted ingredients may be added according to the capsule formulation and applicable requirements.
2. Dipping
Stainless-steel mold pins for the capsule body and cap are dipped into the prepared gelatin solution.
The dipping temperature, immersion depth, withdrawal speed and gelatin viscosity affect the shell thickness and uniformity.
3. Rotation and Distribution
The coated pins are rotated to distribute the gelatin evenly and reduce differences in shell-wall thickness.
4. Drying
The gelatin film is dried under controlled temperature, humidity and airflow conditions.
Improper drying may result in deformation, brittleness, uneven moisture or dimensional instability.
5. Stripping and Trimming
The dried capsule shells are removed from the pins and trimmed to the required length.
6. Joining
The capsule body and cap are assembled to form the finished empty capsule.
7. Inspection
The capsules are inspected for appearance, dimensions, defects, moisture, mechanical properties and other required quality parameters.
Important Selection Factors
Hard capsule gelatin should not be selected solely according to Bloom strength.
The following parameters must be evaluated together:
Gel Strength
Affects shell strength, dimensional stability and resistance to deformation.
Viscosity
Affects dipping behavior, film thickness, machine speed and shell-weight consistency.
Gelatin Solution Temperature
Influences viscosity, film formation and the amount of gelatin retained on the mold pins.
Drying Conditions
Temperature, humidity and airflow affect drying speed, residual moisture, shrinkage and brittleness.
Final Shell Moisture
Capsule-shell moisture influences flexibility, mechanical strength and storage stability.
Fill-Material Compatibility
Hygroscopic, strongly acidic, strongly alkaline, reactive or high-moisture ingredients may affect gelatin-shell stability.
Storage Climate
Low-humidity conditions may increase brittleness, while high humidity may soften or deform the capsule shell.
Immediate-Release and Enteric Applications
Standard hard gelatin capsule shells are normally intended for conventional immediate-release applications.
Enteric or delayed-release performance should not be claimed based on standard gelatin alone.
Where gastric resistance or intestinal release is required, the customer may need:
A specially designed capsule-shell system
An enteric coating applied to the finished capsule
A compatible formulation and sealing process
Disintegration and dissolution validation
Stability testing under the intended storage conditions
The suitability of any enteric or delayed-release system must be verified by the capsule manufacturer and finished-product producer.
Packaging and Storage
Standard Packaging
Normally 25 kg net per bag, with a moisture-resistant inner liner and a suitable outer bag.
Pallet packaging, shipping marks and customized export packaging can be discussed according to the order requirements.
Storage Conditions
Store in a cool, dry and well-ventilated warehouse.
Keep the packaging tightly closed and protect the gelatin from:
Moisture
Excessive heat
Direct sunlight
Strong odors
Pests
Chemical contamination
Do not place the bags directly on the floor or against warehouse walls.
