Pharmaceutical Excipient

Gelatin (Pharma Grade)

Name: Gelatin (Pharma Grade)
Brand: Chelora Pharmachem
SKU: CAS-9000-70-8
Availability: InStock

CAS 9000-70-8 · Bloom 80–300 g · IP / BP / USP-NF

The gold-standard shell-forming excipient for hard and soft capsules, with proven applications in tablet coating, microencapsulation and surgical haemostasis. Chelora supplies Type A (porcine), Type B (bovine) and hydrolysed grades — all BSE/TSE compliant — with full batch documentation to IP, BP and USP-NF.

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IP / BP / USP-NF grades
BSE/TSE compliant
Samples to bulk

80–300 g

Bloom strength range

CAS number

9000-70-8

Bloom range

80 – 300 g

Pharmacopoeia

IP · BP · USP-NF

Transport

Non-DG

Product overview

From collagen to capsule shell

Gelatin is a purified protein obtained by the partial hydrolysis of collagen derived from animal skin, bone and connective tissue. It is one of the oldest and most thoroughly characterised pharmaceutical excipients, with a continuous pharmacopoeial history spanning more than a century.

Two main types are distinguished by their manufacturing process. Type A gelatin is produced by acid treatment of porcine skin, yielding a product with a high isoelectric point (pH 7–9). Type B gelatin results from prolonged alkaline (lime) treatment of bovine bone and hide, giving a lower isoelectric point (pH 4.7–5.3). The choice of type affects charge behaviour, film clarity and compatibility with certain formulation excipients.

Gelatin's defining property is its ability to form thermo-reversible gels: it dissolves in warm water above approximately 40 °C and sets into an elastic gel on cooling. This gel-forming behaviour underpins its role as the primary shell material for both two-piece hard capsules and one-piece soft gelatin (softgel) capsules — together accounting for the majority of oral solid dosage units manufactured globally.

Beyond capsule manufacture, gelatin serves as a tablet-coating and binding agent, a wall material in coacervation microencapsulation, a matrix for absorbable haemostatic sponges and wound dressings, and the gelling agent in confectionery (gummy vitamins, marshmallows). Hydrolysed (low-Bloom) grades are valued for their binding properties in wet granulation without the high gel strength that would impede disintegration.

Technical specifications

Common nameGelatin (Gelatine)

SynonymsPharmaceutical gelatin, Gelatin NF, Gelatina

CAS number9000-70-8

Chemical natureProtein polymer derived from partial hydrolysis of collagen

Source — Type AAcid-treated porcine skin

Source — Type BAlkali-treated (limed) bovine bone and hide

Molecular weight15 000 – 250 000 (polydisperse)

AppearancePale yellow to amber translucent sheets, granules or powder

SolubilitySoluble in warm water (≥ 40 °C); gels on cooling; insoluble in cold water, ethanol, ether

Bloom strength80 – 300 g (grade-dependent)

Viscosity (6.67 % at 60 °C)2.0 – 7.5 mPa·s

pH (1 % at 25 °C)3.8 – 7.6 (Type A ~3.8–6.0; Type B ~5.0–7.6)

Moisture≤ 15.0 %

Ash≤ 2.0 %

Sulphur dioxide (SO₂)≤ 40 ppm

Heavy metals (as Pb)≤ 15 ppm

Isoelectric point — Type ApH 7 – 9

Isoelectric point — Type BpH 4.7 – 5.3

Microbial limitTotal aerobic count ≤ 1 000 cfu/g; absent E. coli, Salmonella

BSE/TSE complianceBovine-origin grades comply with EDQM CEP and EMA/410/01 rev. 3

StorageCool, dry place; protect from moisture; tightly closed

TransportNot classified as dangerous goods (Non-DG)

Applications & end uses

Industries that depend on Gelatin

Hard capsule shell (Type A & B)

Gelatin is the primary shell-forming material for two-piece hard capsules (e.g. size 00–5). Type A and Type B gelatins at Bloom 200–300 produce shells with the elasticity, clarity and dissolution performance required by pharmacopoeias worldwide.

Soft gel capsule shell

Soft gelatin (softgel) capsules use plasticised gelatin films to encapsulate liquid or semi-solid fills. Bloom strength, viscosity and moisture control are critical to seamless capsule manufacture on rotary-die equipment.

Tablet coating & binding agent

Low-Bloom and hydrolysed gelatins serve as wet-granulation binders and tablet-coating film formers, improving tablet hardness and providing a smooth, glossy finish that aids swallowability and taste masking.

Microencapsulation wall material

Gelatin’s coacervation properties make it the excipient of choice for complex coacervation microencapsulation of flavours, fragrances, actives and phase-change materials in pharma, food and personal-care products.

Wound dressing & haemostatic sponge

Cross-linked gelatin sponges (e.g. Gelfoam) are absorbable haemostats used in surgery to control bleeding. Gelatin-based wound dressings promote moist healing and are biocompatible and biodegradable.

Food & confectionery (gummies, marshmallows)

High-Bloom gelatin is the gelling agent behind gummy vitamins, marshmallows, jelly confections and dairy desserts. Its thermos-reversible gel, mouthfeel and foam-stabilising properties are difficult to replicate with alternatives.

Available grades

Type A, Type B and hydrolysed grades

All bovine-origin (Type B) grades comply with EDQM CEP and EMA/410/01 rev. 3 guidelines for TSE safety. Halal certification is available on request for qualifying bovine grades.

Bloom 200–300

Type A (acid-treated, porcine)

Hard & soft capsule shells, confectionery

Bloom 150–250

Type B (alkali-treated, bovine)

Hard capsules, tablet coating, sponges

Bloom 80–120

Hydrolysed / low-Bloom

Wet granulation binder, microencapsulation

Packaging options

Sealed and labelled to pharmacopoeia standard

25 kg bag — Multi-layer paper bag with PE liner

Standard pharmaceutical unit

50 kg bag — Multi-layer paper bag with PE liner

Bulk formulation supply

Sample — Sealed HDPE container

QC evaluation before commitment

Documentation supplied

Complete paperwork for QC and regulatory

Certificate of Analysis (COA)

Batch-specific results for Bloom strength, viscosity, pH, moisture, ash, SO₂, heavy metals and microbial limits.

Safety Data Sheet (SDS)

GHS-format, 16-section SDS covering handling, first aid, fire-fighting and disposal.

Specification sheet

Limit values for each test parameter aligned to IP, BP or USP-NF monograph.

BSE/TSE compliance certificate

EDQM Certificate of Suitability (CEP) confirming TSE safety of bovine-origin grades.

Frequently asked questions

Common questions about Gelatin

What is the difference between Type A and Type B gelatin?+

Type A gelatin is produced by acid treatment of porcine skin and has an isoelectric point around pH 7–9. Type B gelatin is produced by alkaline (lime) treatment of bovine bone and hide and has an isoelectric point around pH 4.7–5.3. Both types are used in capsule shells; the choice depends on formulation pH, regulatory requirements and dietary restrictions.

Is bovine-origin gelatin safe regarding BSE/TSE?+

Yes. Our bovine-origin Type B gelatin complies with the EDQM CEP (Certificate of Suitability) and EMA/410/01 rev. 3 guidelines on minimising TSE risk. Raw materials are sourced from countries with negligible or controlled BSE risk, and the manufacturing process includes validated inactivation steps.

Which Bloom strengths are available?+

We supply gelatin across Bloom 80–300 g. Hard and soft capsule grades are typically Bloom 200–300 (Type A) or 150–250 (Type B). Low-Bloom / hydrolysed grades (80–120) are available for binding and microencapsulation applications.

Can gelatin be used in vegetarian or halal formulations?+

Gelatin is an animal-derived protein and is not vegetarian. For halal compliance, our Type B (bovine) gelatin can be supplied with halal certification on request, provided the sourcing and slaughter requirements are met. For vegetarian alternatives, consider HPMC capsule shells.

What pharmacopoeia standards does Chelora gelatin meet?+

Our gelatin is manufactured to meet Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) and United States Pharmacopeia – National Formulary (USP-NF) monograph specifications. Each batch ships with a COA confirming compliance with the relevant standard.

What is the typical lead time for a bulk gelatin order?+

Standard lead time is 5–10 working days for domestic orders and 10–14 days for export, depending on type, Bloom strength and volume. Type A (Bloom 250) and Type B (Bloom 200) are commonly held in ready stock.

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