Gelatin (Pharma Grade) CAS 9000-70-8

What is Gelatin (Pharma Grade)?

Gelatin is not a defined chemical but a mixture of polypeptides obtained by partial hydrolysis of collagen. It has no fixed molecular formula, and it is specified by what it does rather than by what it is — principally by Bloom strength, the force needed to depress a standard gel under standard conditions.

Its defining property is thermoreversible gelation. A gelatin solution sets to a gel on cooling and melts again on warming, repeatedly, at temperatures close to body temperature. Capsule manufacture is built directly on that behaviour, and so is its use in confectionery and in a range of pharmaceutical gels.

Two types are supplied, distinguished by how the collagen was pretreated. Type A comes from acid processing, typically of porcine skin, and has an isoelectric point around pH 7 to 9. Type B comes from alkaline lime processing, typically of bovine hide or bone, with an isoelectric point around pH 4.7 to 5.2. The difference matters when the gelatin has to coexist with a charged active or a charged polymer.

Commercially, gelatin is dominated by capsule manufacture — hard shells and softgels together account for most pharmaceutical demand. Its distinguishing commercial feature is traceability: because it is animal-derived, BSE/TSE documentation, source declaration and religious certification are part of the product rather than optional extras.

Why gelatin specifically

• Thermoreversible gelation near body temperature. It sets on cooling and melts on warming, which is what makes a capsule shell that is solid in the bottle and dissolves in the stomach.
• Film forming and mechanically strong. Gelatin films are tough enough to survive filling, packing and handling while remaining thin.
• A long regulatory history. It has been used in medicines for well over a century, so its acceptance is settled in a way newer alternatives are still establishing.
• Bloom gives a direct performance dial. Specifying Bloom strength specifies gel firmness directly, which is a more useful handle than any chemical parameter would be.

How Gelatin is Manufactured

Gelatin is made by hydrolysing collagen from hide, skin or bone. The pretreatment decides the type, and the extraction conditions decide the Bloom strength.

• Raw material selection and traceability. Porcine skin, bovine hide or bone from controlled sources, with full traceability documentation — this is a regulatory requirement for this product, not a commercial nicety.
• Pretreatment. Acid pretreatment over hours to days gives Type A; alkaline lime pretreatment over weeks gives Type B. This single choice determines the isoelectric point and much of the behaviour.
• Extraction. Collagen is extracted in hot water in successive extracts at rising temperature. Early extracts give the highest Bloom; later ones give progressively lower Bloom material.
• Filtration and purification. Filtration, ion exchange and deionisation remove salts, fats and colour. Ash and conductivity figures reflect how thoroughly this ran.
• Concentration, sterilisation and drying. Concentrated, heat-treated, chilled to a gel, dried and milled. Drying temperature affects both colour and the degree of any further degradation.

Typical Commercial Specification

Figures below are representative of pharmaceutical capsule-grade gelatin. Bloom, viscosity and type should all be specified — tell us your capsule type and machine and we will advise on the grade.

Physical & Chemical Properties

Behaviour in the formulation

Gelatin is a protein and behaves like one — charge, temperature and chemical modification all matter:

• Thermoreversible gelation. Sets and melts repeatedly with temperature, which is what capsule manufacture exploits on the dipping pin and in the softgel ribbon.
• Film formation. Forms strong, thin, flexible films, with plasticiser content setting the difference between a hard shell and a softgel.
• Amphoteric charge behaviour. Carries net positive or negative charge depending on pH relative to its isoelectric point, which governs compatibility with charged actives and polymers and differs between Type A and Type B.
• Cross-linking. Aldehydes, peroxides and even some packaging materials cross-link the protein into an insoluble pellicle. The capsule then fails to dissolve while looking entirely normal.
• Microbial substrate. Gelatin solutions are an excellent growth medium, so hold times and temperatures in a capsule plant are controlled as much microbiologically as rheologically.

Type A vs Type B Gelatin and the Alternatives

The type is a processing distinction with real formulation consequences, and the main alternative exists mostly to avoid the animal origin question entirely.

Stated plainly: Type A and Type B differ by isoelectric point, and that decides how the shell behaves with a charged fill. The move to HPMC capsules is driven less by performance than by origin — vegetarian, halal and kosher requirements, and the lower moisture content that suits hygroscopic fills. Gelatin still holds the majority of the market on cost, machine speed and a century of regulatory familiarity.

Industries We Supply Gelatin To

The same amber granules go to a hard capsule plant, a softgel line and a confectionery works. What changes between them is the Bloom, the type and the certification each market requires.

Where Gelatin is Used

Gelatin is bought overwhelmingly for capsules, with a long tail of gelling and film applications behind it. These are the end uses our customers buy it for.

In hard capsule manufacture

Stainless steel pins are dipped into a warm gelatin solution, withdrawn, and the film sets as it cools on the pin before being dried, stripped, cut and joined. Everything about the process depends on getting the solution's viscosity and setting behaviour right, which is why capsule makers specify Bloom and viscosity together rather than either alone. Moisture content in the finished shell is critical too: too dry and the shells crack, too wet and they soften and deform.

In softgel manufacture

Softgel shells are gelatin plasticised with glycerol or sorbitol, formed into a ribbon and sealed around the fill in a rotary die. The plasticiser content is what makes the difference between a hard shell and a soft one. The main formulation risk is interaction between the fill and the shell — water migrating in either direction, and fill components that promote cross-linking in the shell.

The cross-linking problem

This deserves its own section because it causes more capsule product failures than anything else. Trace aldehydes — from the fill, from an excipient, from packaging, or generated by oxidation of PEG or other components — react with the gelatin to form an insoluble pellicle. The capsule looks normal but will not dissolve, and dissolution testing fails at twelve or eighteen months with nothing in the manufacturing record to explain it. Controlling peroxides and aldehydes in gelatin, in the fill and in the packaging is the whole preventive strategy.

Quality Control & Testing

Every lot is released against a batch-specific Certificate of Analysis written against the monograph you nominate, with the functional and traceability documentation this product requires.

• Bloom strength — the defining performance parameter, measured under standard conditions on a standard gel.
• Viscosity — measured on a standard solution. Specified alongside Bloom because the two together determine machine behaviour.
• Moisture — critical for shell integrity; too low and shells crack, too high and they deform.
• Peroxides and sulphur dioxide — the cross-linking risk factors, and the figures that predict dissolution stability.
• pH and isoelectric point — confirming type and predicting compatibility with charged fills.
• Ash and heavy metals — inorganic residue and elemental impurity control.
• Microbial limits and specified organisms — including absence of E. coli and Salmonella, which matters particularly for an animal-derived material.

Common Process Problems & Likely Causes

When gelatin causes trouble, it is usually cross-linking, moisture or a Bloom and viscosity mismatch. This table is the shortcut our technical desk works through before anyone opens a complaint file.

Packaging, Storage & Shipping

• Standard packing. 25 kg net in multi-ply paper bags with polyethylene inner liners, palletised and shrink-wrapped.
• Moisture control. Gelatin equilibrates with ambient humidity, and its moisture content is a functional specification. Keep bags sealed and store in controlled humidity — this matters more than for most excipients.
• Storage. Cool, dry and well-ventilated, off the floor, away from strong odours, aldehyde sources and oxidising agents.
• Aldehyde segregation. Do not store near materials that could release aldehydes, and consider packaging materials in the same light. Cross-linking is initiated by traces.
• Microbiological control. As an animal-derived protein it carries microbial specifications. Keep storage clean and dry and avoid condensation on bags brought from cold stores.
• Solution hold times. Prepared solutions support microbial growth at working temperature. Hold time and temperature limits belong in the SOP.
• Shelf life. Typically 36 months in unopened original packing under those conditions. Re-test Bloom, moisture and microbial limits rather than assume.
• Transport classification. Not classified as a dangerous good for transport.

Hazards & Safe Handling

Gelatin is a food protein with no significant toxicity, used in medicines and food worldwide. The handling considerations are physical and microbiological rather than toxicological.

• Dust explosion risk. Like any fine organic powder, airborne gelatin presents a dust explosion hazard. Earth and bond transfer equipment and control ignition sources.
• Microbiological hygiene. Gelatin solutions support microbial growth readily. Plant hygiene, hold time limits and cleaning validation matter more here than with synthetic excipients.
• Nuisance dust. Not toxic, but airborne dust irritates the respiratory tract mechanically. Local exhaust ventilation at charging points.
• Hot solution handling. Solutions are prepared warm and can cause scalds. Standard thermal precautions where solutions are made and transferred.
• Allergen considerations. Rare but documented sensitivity to gelatin exists, which is a patient-facing labelling matter rather than a handling hazard.
• PPE. Dust mask where dust is generated, safety glasses and normal plant workwear. No special chemical protection is required.
• Spill response. Sweep or vacuum dry, avoiding dust clouds. Wet gelatin becomes slippery and then sticky as it dries.
• Environment. Not hazardous to the aquatic environment, though it has a high biological oxygen demand. Dispose as ordinary industrial waste.

Regulatory & Compliance Notes

Gelatin is a compendial excipient with monographs in all the major pharmacopoeias, and the most heavily documented product in this range because of its animal origin. Because obligations differ by territory and use, the notes below are orientation rather than legal advice — confirm your own position with your regulatory adviser.

• BSE/TSE compliance. This is the central regulatory requirement for gelatin. Material is sourced and processed in line with the applicable TSE guidance, with certification, source country declaration and full traceability supplied as standard with every consignment.
• Pharmacopoeial status. Monographs in IP, BP, Ph. Eur. and USP. We supply against the monograph you nominate, with a compliance statement on the COA.
• Source declaration. Porcine or bovine origin is declared explicitly. This matters for religious, dietary and regulatory reasons and is frequently the first question a customer asks.
• Halal and kosher certification. Available on request and specified more often for this product than for any other in the range, given the origin question.
• Patient labelling. Finished products may need to declare gelatin origin in some markets, which begins with your excipient choice and documentation.
• Excipient GMP expectations. Supply chains for animal-derived compendial excipients expect documented GMP, supplier qualification and traceability. Tell us what your quality agreement requires.

We Supply Gelatin Worldwide

Chelora Chemicals is a supplier and export partner, not a single-plant trader. We ship Gelatin (Pharma Grade) from India to customers across Asia, Europe, the Middle East, Africa, and North and South America, handling the export documentation, BSE/TSE certification and traceability documentation and freight so the material arrives ready to use.

• Incoterms. EXW, FOB, CIF, CFR and DAP quoted to suit your purchasing terms and freight arrangements.
• Ports. Regular shipments through Nhava Sheva (JNPT) and Mundra, with other Indian ports arranged where it suits the routing.
• Documentation. Commercial invoice, packing list, certificate of origin, COA, SDS and the BSE/TSE certificate, source declaration and religious certification issued as a complete set.
• Flexible volumes. A single bag for laboratory qualification, through LCL consolidations, up to repeat full container loads on a supply contract.
• Supply continuity. Because we are independent of any one producer, a plant turnaround or a shipping disruption at one source does not have to become your stock-out.

Buying Gelatin from Chelora

We are an independent sourcing and supply partner. For gelatin that means settling three things at enquiry: the type and Bloom, the viscosity that goes with it, and your origin and certification requirements — because for this product the paperwork is as much a part of the specification as the Bloom number.

• Documentation on every lot. Batch-specific COA with Bloom, viscosity, moisture and peroxides, plus BSE/TSE certificate, source declaration, SDS and TDS.
• Samples before commitment. Trial quantities for machine and dissolution qualification ahead of a commercial order.
• Quantities. From a single 25 kg bag through to full container loads on contract supply.
• Type and Bloom range. Type A and Type B across the usual Bloom range, with blends made to a target where a single grade will not match both Bloom and viscosity.
• Certification. Halal and kosher certification available, with source country declared explicitly on every consignment.
• Related excipients. HPMC for vegetarian capsule shells, plus PEG, MCC and the wider excipient range from one supplier.

How ordering works

• Send the enquiry. Product, grade or pharmacopoeia standard, quantity, destination port and the Incoterm you buy on. If you have a spec sheet, attach it — it saves a round trip.
• We quote. Price, lead time, packing and a sample COA, normally within one working day.
• Sample and qualify. For first orders or critical applications, we send a trial quantity so your lab can sign off before you commit.
• Confirm the order. Proforma invoice issued; payment terms agreed against the volume and the relationship.
• Production and QC. Material allocated and released against a batch-specific COA, with a pre-shipment sample where the application calls for it.
• Ship and document. Packed, labelled and loaded with the full export document set, and tracked through to arrival.

Related Pharmaceutical Excipients & Intermediates

Buyers of gelatin usually source several of these alongside it — softgel and capsule plants typically buy PEG and HPMC on the same order. Consolidating them cuts freight cost and gives you a single point of contact for documentation.