High Bloom Gelatin for Hard Capsules

The Essential Excipient for Two-Piece Capsules

Gelatin for Hard Capsules is the globally trusted primary excipient for producing two-piece pharmaceutical and nutraceutical shells. These capsules require a material that provides superior structural rigidity, rapid dissolution, and exceptional film-forming properties to withstand high-speed automated filling processes. Our hard capsule gelatin is engineered with a focus on maximizing Bloom strength and ensuring precise viscosity control, guaranteeing the production of firm, defect-free capsule shells.

Key Technical Specification of Gelatin for Hard Capsules

ITEMS	SPECIFICATIONS (TEST METHOD)	Remark
Appearance	Yellowish to white free-flowing granular powder	Pass
Jelly Strength (Bloom) 220 – 280 Bloom (6.67%) High strength for optimal shell firmness
Viscosity (6.67% sol.)	3.5 – 5.5 mPa.s	Controlled flow for uniform dipping and coating
pH (at 55℃)	4.0 – 6.5	Consistent profile
Loss on Drying	≤ 15%	Standard moisture content
Sulphur Dioxide	≤50ppm	Low content to minimize cross-linking risk
Heavy Metals (as Pb)	≤ 10 ppm	Meets stringent pharmaceutical limits
E. Coli / Salmonella	Absent	Sterile

Specialized Characteristics for Hard Capsule Production

The key to a high-quality hard capsule lies in the gelatin's ability to form a strong, dimensionally stable film during the dipping and drying phase. Our gelatin is characterized by three critical features:

Confectionery Applications

Ultra-High Bloom Strength (220-280g)

1.This is the measure of gel firmness. High Bloom ensures the capsule shells are robust, rigid, and resistant to deformation or breaking during mechanical handling and high-speed filling, providing maximum integrity for the final dosage form.

Controlled Viscosity:

2.Precise viscosity dictates the thickness and uniformity of the gelatin film deposited on the dipping pins. Maintaining a tight viscosity range is crucial for achieving consistent shell thickness and weight, which directly impacts the drug's release profile and dosage accuracy.

Low Residual Moisture:

3.Although the final capsule shell has a controlled moisture content (13–16%), the raw gelatin powder is purified to ensure low moisture and minimal sulfur dioxide content. This purity is vital to prevent adverse interactions with moisture-sensitive APIs and minimize the risk of gelatin cross-linking over time, which can impair dissolution.

Why Gelatin is the Ideal Hard Capsule Material

1

Rapid Solubility:

Gelatin is a natural protein that rapidly dissolves in biological fluids at body temperature, ensuring the fast and reliable release of the enclosed powder or granules in the stomach.
2

Film Flexibility and Strength:

t forms a strong, yet flexible film that minimizes the risk of cracking (brittleness) when stored under controlled humidity conditions, protecting the active filling.
3

Chemical Inertness:

Gelatin is non-toxic and chemically stable, providing an inert barrier that preserves the efficacy and stability of the enclosed pharmaceutical or nutraceutical ingredients.

Advanced Technical Control in Manufacturing

Decades of Experience:

With over two decades in the gelatin industry, our manufacturing staff possesses profound expertise in controlling the precise variables (temperature, air flow, humidity) during the critical dipping and drying stages of capsule manufacturing. We understand how different gelatin characteristics perform on high-speed encapsulators.

Batch-to-Batch Consistency:

Our advanced hydrolysis and purification lines are governed by rigorous SOPs to ensure every single batch of gelatin exhibits the identical Bloom, Viscosity, and purity profile, eliminating the major variable that can disrupt high-throughput capsule production.

Full Regulatory and Technical Documentation

Full Traceability:

We implement a fully documented traceability system from the procurement of BSE-free raw materials (bovine bones or hides) through every stage of extraction, purification, and finished product release, ensuring total transparency and risk mitigation.

Detailed Technical Dossier:

We provide more than just a certificate. Our comprehensive documentation includes the Product Certificate of Analysis (COA), detailed Methods of Analysis, reports on Testing Method Validation, and data from Stability Studies to support shelf-life claims.

Elemental Impurity Control:

We furnish specific documentation confirming adherence to international pharmacopeial standards for controlling heavy metals and other Elemental Impurities.

Logistics and Packaging for Product Integrity

Standard Packing:

Our gelatin is packed in multi-ply paper bags with an inner moisture-proof layer, sealed in 25KG net weight units.
Container Loading Capacity:

A standard 40-foot container carries approximately 16–18 tons of palletized goods, facilitating efficient global distribution.
Global Shipping Support:

We possess deep experience exporting to all major regulated markets, providing all necessary documents for customs clearance, including Health Certificates, Certificates of Origin, and notarized Analysis Reports (COA).

Why Choose us?

1

Robust Production Capacity

Beyond Biopharma operates with an annual production capacity of 15,000 tons and three advanced manufacturing lines, ensuring consistent product quality and reliable, on-time delivery for global customers.
2

Deep Industry Expertise

The company’s production team brings over 20 years of practical experience, supported by more than five decades of accumulated technical know-how and continuous innovation in gelatin manufacturing.
3

Comprehensive Technical Support

An experienced sales force and dedicated technical specialists provide full-cycle support, including pre-sales formulation guidance and post-sales application assistance, ensuring seamless integration into customer processes.
4

Strong Customization Capabilities

Beyond Biopharma offers tailored solutions such as customized viscosity levels and particle size specifications, enabling customers to meet precise formulation and manufacturing requirements.

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+86 18657345785

NO.137 Haining Road, Hongkou District, Shanghai China

High Bloom Gelatin for Hard Capsules

The Essential Excipient for Two-Piece Capsules

Key Technical Specification of Gelatin for Hard Capsules

Specialized Characteristics for Hard Capsule Production

Confectionery Applications

Ultra-High Bloom Strength (220-280g)

Controlled Viscosity:

Low Residual Moisture:

Why Gelatin is the Ideal Hard Capsule Material

Rapid Solubility:

Film Flexibility and Strength:

Chemical Inertness:

BEYOND Biopharma: Confidence in Hard Capsule Supply

Advanced Technical Control in Manufacturing

Decades of Experience:

Batch-to-Batch Consistency:

Full Regulatory and Technical Documentation

Full Traceability:

Detailed Technical Dossier:

Elemental Impurity Control:

BEYOND BIOPHARMA CO., LTD

Logistics and Packaging for Product Integrity

Standard Packing:

Container Loading Capacity:

Global Shipping Support:

Why Choose us?

Robust Production Capacity

Deep Industry Expertise

Comprehensive Technical Support

Strong Customization Capabilities

CONTACT

Your Name：*

Country：*

Company：*

Email：*

Phone (with Country Code)：*

Message：*

contact

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