Gelatin, Pharma Grade
Gelatin is the only excipient on this range where the animal comes before the chemistry. Bovine, porcine or fish decides your halal and kosher position, your TSE file and your labelling — and all of that is settled before anyone talks about bloom strength.
Chelora Chemicals supplies pharmaceutical gelatin to capsule manufacturers and formulators worldwide, across types, blooms and origins, with a batch COA, GHS safety data sheet and the origin, TSE and certification documentation your QA file needs.
Product identity
- CAS Number
- 9000-70-8
- Compendial name
- Gelatin / Gelatina
- Chemical description
- Partially hydrolysed collagen
- Types
- Type A (acid) · Type B (alkali)
- EC / EINECS
- 232-554-6
- Bloom range
- 50 – 300 g
- Pharmacopoeias
- USP-NF · Ph. Eur. · JP · IP · BP
- HS Code
- 3503 00*
* Confirm the HS heading and the veterinary import position with your customs broker — gelatin is animal-derived and several destinations apply health certification and import permits on top of the ordinary tariff.
What Pharma Grade Gelatin is used for
Gelatin is a pale yellow to amber granule, powder or sheet — collagen that has been partially hydrolysed so that it dissolves in warm water and sets to a gel on cooling. That thermoreversible gelling behaviour is the whole basis of the capsule industry: a gelatin solution can be dipped, dried and later dissolved again in the gut.
Its dominant pharmaceutical use is in hard and soft capsule shells. Beyond that it serves as a tablet binder, a microencapsulation wall material, a stabiliser in vaccines and biologicals, the base for haemostatic sponges, and — as modified fluid gelatin — a plasma volume expander.
Where the types and origins differ
- Type A, acid-processed usually porcine skin; isoelectric point around 7–9, so it carries a net positive charge at typical formulation pH.
- Type B, alkali-processed usually bovine hide or bone; isoelectric point around 4.7–5.4, net negative at the same pH.
- Fish gelatin lower gelling and melting temperature; chosen where both bovine and porcine origin are ruled out.
- Hypromellose the vegetarian capsule alternative, and a reformulation rather than a substitution. See that page.
The charge difference between Type A and Type B matters whenever an ionic active or a charged excipient is in the shell — see the full excipient range.
Appearance and handling character
The material is hygroscopic, soluble in warm water and insoluble in cold, swelling to several times its weight before it dissolves. It is not classified as a hazardous substance. The handling questions that matter are moisture control, microbial load — this is a protein and a growth medium — and the slow cross-linking that occurs on exposure to heat, humidity, light and trace aldehydes, which is the single most common cause of capsule dissolution failures.
| Parameter | Typical value |
|---|---|
| Appearance | Pale yellow to amber granules or powder |
| Bloom strength | Per grade, ±10% of nominal |
| Viscosity (6.67%, 60 °C) | Per grade |
| Moisture | 14.0% max |
| Sulphated ash | 2.0% max |
| pH (1% solution) | Type A 3.8 – 5.5 · Type B 5.0 – 7.5 |
| Sulphur dioxide | 50 ppm max |
| Peroxides | 10 ppm max |
| Microbial limits | TAMC ≤ 1000 cfu/g · absence of E. coli & Salmonella |
Important: the figures above are indicative of compendial-grade material and are offered for planning only. The batch certificate of analysis is the governing document. Bloom, viscosity and origin are what define the product — tell us all three and we will quote against them.
| Requirement | Usual answer |
|---|---|
| Hard capsule shells | Type B bovine, 150–250 bloom |
| Soft capsule shells | Type A or B, 150–200 bloom |
| Halal or kosher market | Bovine or fish, certified |
| Avoiding bovine origin | Porcine Type A, or fish |
| Tablet binder | Lower bloom, 50–125 |
| Vegetarian label required | Hypromellose — not gelatin |
Capsule manufacturers commonly blend two blooms to hit a target shell property. Send us your current blend and we will match it rather than quoting a single nominal figure.
Where our customers put this excipient to work
Overwhelmingly capsules — but the parenteral and biological applications are where the specification gets demanding.
Hard capsule shells
Dip-moulded from a warm gelatin solution, dried and cut — the largest single use, and the one where bloom consistency matters most.
- Type B bovine, 150–250 bloom
- Bloom and viscosity per batch
- Blend matching supported
Soft gelatin capsules
Ribbon-cast with a plasticiser, usually glycerin or sorbitol, then rotary-die encapsulated around an oily or semi-solid fill.
- Pairs with PEG 400 in fills
- Cross-linking control critical
- Technical desk review of your shell
Tablet binder
Lower-bloom grades used as a solution binder in wet granulation where a strong, cohesive granule is wanted.
- 50–125 bloom grades
- Alternative to PVP K30
- Blend trials supported
Microencapsulation
Used as the wall material in coacervation processes, encapsulating oils, flavours and actives in a protein shell.
- Type A and B used together
- Isoelectric point drives the process
- Custom specification available
Vaccines & biologicals
Used as a stabiliser in some vaccine formulations and as the base for absorbable haemostatic sponges.
- Parenteral-grade specification
- Endotoxin and origin critical
- Full traceability documentation
Nutraceutical & food
Softgel supplements, gummies and confectionery, and collagen-type nutritional products, at food-grade specification.
- Food-grade specification available
- Halal and kosher certification
- Bulk and contract supply
How we supply Pharma Grade Gelatin
Chelora Chemicals is a supplier and sourcing partner, not a manufacturer. On an animal-derived excipient, owning no plant means we are not tied to one species or one slaughterhouse chain — we route your order to the producer whose origin, certification and TSE file actually match the market you are selling into.
We place your order with whichever qualified producer best matches your type, bloom, origin, certification requirement and your delivery window.
We keep a second qualified source on this line. Gelatin supply is tied to livestock processing and to veterinary trade rules, both of which can move without warning.
- Origin settled before anything else. Bovine, porcine or fish decides certification, labelling and TSE documentation, so it is the first question on every enquiry.
- TSE documentation verified, not forwarded. Geographical source, tissue type and processing conditions stated explicitly, with CEP availability confirmed per source.
- Halal and kosher certification checked at source. Certificates travel with the consignment and are checked against the certifying body your market recognises.
- Bloom and viscosity trended batch to batch. On a capsule line these two figures set your shell thickness and your machine speed, so the trend matters as much as the limit.
- Veterinary import position checked before quoting. Animal-derived material attracts health certificates and import permits at several destinations, and we establish that before you raise the PO.
- Change notification taken seriously. A change of species, country of origin or tissue type is a regulatory event, and you hear about it from us first.
Packed the way your plant receives it
Gelatin is hygroscopic and microbially sensitive, so the pack is a barrier before it is a container. Tell us the destination climate and we will quote the right format.
Multiwall bags, PE-lined
Kraft bags with a sealed inner liner on shrink-wrapped pallets — the standard pharmaceutical format.
Foil-laminate barrier bags
For humid destinations and long sea legs, where a PE liner alone will not hold moisture out for the transit time.
Lined fibre drums
Where your store handles drums rather than bags, or for parenteral-grade material transferred into a controlled area.
Trial / sample quantities
Small sealed packs for shell and blend trials, subject to destination import rules for animal-derived material.
Incoterms to suit you
Quoted on the Incoterm your purchasing team works to, with veterinary and export documentation filed before the booking.
Campaign despatch
We hold contracted tonnage and release it against your production calendar — worth doing on a material that ages in store.
Cross-linking is the failure mode to watch
Gelatin is a food protein and is not classified as hazardous. The risk on this product is not to the operator; it is that the material quietly changes in store and your capsules stop dissolving on stability. The summary below is orientation only — the safety data sheet supplied with your consignment is the authoritative document.
Hazard position
GHSNot classified as a hazardous substance or mixture.ANIMALAnimal-derived — TSE, allergen and dietary labelling considerations apply.MICROA protein substrate; microbial control in storage and in solution is essential.XLINKCross-links on exposure to heat, humidity, light and aldehydes.
Cross-linking is the issue that recalls capsule batches. It is invisible to the eye, it does not show on a standard identity test, and it presents as a dissolution failure months after release. Always read the SDS issued with your specific batch.
Practical handling notes
- Keep aldehydes away from gelatin, everywhere. Traces from packaging, adhesives, excipient degradation or even cleaning agents will cross-link a shell. This belongs in your packaging qualification, not just your warehouse rules.
- Never hold gelatin solution warm for long. A protein solution at 50–60 °C is an excellent growth medium and loses bloom as it stands; make it fresh and use it within the shift.
- Bloom falls with every reheat. Repeated melting hydrolyses the chains further, so a solution should not be cycled.
- Re-seal the liner immediately. Moisture pick-up affects both bloom and microbial stability.
- Do not let it dry onto equipment. Dried gelatin film is far harder to clean than wet, and it is a microbial harbourage.
Storage
- Cool, dry, dark, tightly closed store. All four matter: heat, humidity and light each accelerate cross-linking independently.
- Keep well away from aldehyde sources. Including from other materials in the same store — this is a segregation requirement, not a preference.
- Keep the liner intact. A damaged liner is a bloom risk and a microbial risk at the same time.
- Keep off the floor and away from external walls. Standard GMP warehousing practice; condensation reaches the bag before it reaches the room.
- Shelf life typically 36–60 months. In sealed original packing. Re-test bloom, viscosity and microbial limits after extended storage.
Handling & PPE
- Standard GMP powder handling. Local exhaust at tipping points, gloves, safety glasses and a dust mask where airborne powder is generated.
- Microbiological discipline throughout. Clean, dry equipment and short solution hold times; treat gelatin preparation as a hygiene-critical step.
- Control dissolution temperature. Swell cold, dissolve warm, and avoid local overheating that degrades the chains.
- Dedicated equipment where origin matters. On a line running both porcine and bovine material, cross-contamination is a certification problem as well as a GMP one.
- Dispose of as ordinary non-hazardous waste. Subject to your local rules for animal by-products, which can differ.
Transport
Gelatin is not a regulated dangerous good and ships as general cargo. It is, however, animal-derived material, and several destinations require veterinary health certification and an import permit. We confirm that position and arrange the certification before booking — ask us for the full document pack when you plan the shipment.
What travels with every consignment
On an animal-derived excipient the documentation reaches back to the species, the country and the tissue. Verifying that chain is most of what you are buying from a supplier.
Certificate of Analysis
Batch-specific bloom, viscosity, moisture, ash, pH, sulphur dioxide, peroxides and microbial limits against the monographs you cite.
TSE / BSE statement
Species, geographical origin, tissue type and processing conditions stated explicitly, addressing the relevant Ph. Eur. general chapter.
Halal & kosher certification
Certificates from the certifying body your market recognises, checked at source rather than taken from a producer's website.
Veterinary health certificate
Arranged where the destination applies animal by-product import controls, along with the import permit where one is required.
GHS Safety Data Sheet
Full 16-section SDS in GHS format, issued in the language your destination requires, confirming the unclassified status in writing.
Retained & pre-shipment samples
Pre-shipment samples carry the same COA as the commercial lot, so what your laboratory qualifies is exactly what arrives.
Collagen, taken partway apart
Gelatin is collagen with its triple helix broken up far enough to dissolve but not so far that it cannot re-form a network on cooling. The curing route is what produces Type A and Type B. The steps below are the general industrial pattern, not a process disclosure.
Select and clean the raw material
Hide, bone or skin from animals fit for human consumption is cleaned, degreased and, for bone, demineralised.
Cure with acid or alkali
Acid curing over days gives Type A; lime curing over weeks gives Type B. This step sets the isoelectric point.
Extract in hot water
Successive hot-water extractions release gelatin, with the earliest extracts giving the highest bloom.
Filter, concentrate, dry and mill
Filtration, ion exchange, sterilising filtration, concentration, chilling, drying and milling give the finished granule.
Why bloom, viscosity and origin all have to be specified
Gelatin is a natural product, and the specification is doing more work here than on a synthetic excipient:
- Bloom and viscosity are independent. Two lots at the same bloom can have different viscosities, and on a dipping line it is the viscosity that sets shell thickness.
- Extraction sequence shows up in the product. First-extract material behaves differently from later extracts even at matched bloom, which is why batch-to-batch trending matters.
- Isoelectric point drives interactions. A Type A shell and a Type B shell behave differently with an ionic active, and swapping them is a formulation change.
- Origin is a regulatory specification, not a technical one. It will not change how your capsule performs; it decides whether you can sell it in a given market.
That is why we settle origin and certification before bloom, and why the batch COA is shared for approval before dispatch rather than sent with the invoice.
| Material | Character / use |
|---|---|
| Gelatin CAS 9000-70-8 — this product | Animal protein · thermoreversible gel |
| Hypromellose CAS 9004-65-3 | Vegetarian capsule shells |
| Povidone K30 CAS 9003-39-8 | Synthetic solution binder |
| Polyethylene glycol CAS 25322-68-3 | Softgel fill vehicle |
We supply across the excipient range — see the full excipient range. Send your formulation and we will confirm the grades before quoting.
What actually moves the price of this product
Knowing what drives the quote helps you time a purchase and read whether an offer is realistic.
Raw hide and bone supply
Gelatin is a by-product of meat processing, so supply follows livestock slaughter volumes rather than pharmaceutical demand.
- Supply is not demand-responsive
- Herd cycles and feed costs feed through
- We flag raw-material moves in the quote
Origin & certification premium
Certified halal or kosher bovine gelatin costs more than uncertified, and fish gelatin costs considerably more than either.
- Specify certification at enquiry
- Fish gelatin is a premium product
- Certification is part of the price
Bloom grade yield
High-bloom material comes from the earliest extractions and is the scarcer fraction, so it carries a premium over lower blooms.
- High bloom is yield-limited
- Blending can hit a target more cheaply
- Ask us about blend options
Veterinary trade controls
Animal by-product import rules can close a corridor at short notice, which affects availability more sharply than price.
- Check the destination position early
- We confirm before quoting
- Alternate origins can keep supply moving
Source qualification lead time
Changing gelatin source means a new TSE file and usually new shell trials, so a supply gap is expensive in time as well as money.
- We hold a second qualified source on this line
- Qualify the alternate before you need it
- Ask us about dual-source contracts
Nutraceutical & collagen demand
Gummy supplements and collagen nutrition consume enormous volumes and compete directly with pharmaceutical grades.
- Ask us what adjacent demand is doing
- Long-term contracts lock in supply
- We hold inventory on common blooms
| Decide… | Before… |
|---|---|
| Origin (bovine / porcine / fish) | Anything else — it drives certification |
| Halal / kosher requirement | Selecting the source plant |
| Type A or Type B | Formulating with an ionic active |
| Bloom and viscosity | Setting your dipping line parameters |
| Microbial specification | Any parenteral or paediatric use |
| Destination veterinary rules | Raising the purchase order |
Work down this list in order and the quote process is straightforward. Start at bloom and you will usually have to start again once certification comes up.
Support that goes beyond shipping the pallet
What our technical desk will do
- Establish origin and certification first. Everything else on a gelatin enquiry depends on it, and getting it wrong wastes the whole qualification.
- Check the destination's veterinary position. Animal by-product import rules vary and change; we confirm before quoting rather than after the container is booked.
- Raise the cross-linking question. If you have had unexplained dissolution drift on capsules, the conversation should start with aldehyde sources and storage rather than with the gelatin grade.
- Match your existing bloom blend. Most capsule lines run a blend, and matching it is more useful than quoting a single nominal figure.
Regulatory & compliance notes
- TSE compliance is documented per source. Species, country, tissue and process conditions all form part of the file, and a change in any of them is notifiable.
- Dietary and religious labelling varies by market. Porcine origin is a labelling matter in several jurisdictions quite apart from certification.
- Compendial monographs differ in detail. USP-NF and Ph. Eur. are close but not identical on microbial and chemical limits; we confirm coverage.
- Excipient change control is yours to manage. Tell us which products this feeds and we will treat source changes as notifiable rather than routine.
None of the above is legal advice — your own regulatory affairs team owns the final compliance position for your import and your filing. What we commit to is accurate origin data, verified certification and complete documentation to work from.
From enquiry to delivered pallet
Send the specification
Origin, certification requirement, type, bloom and viscosity, the pharmacopoeias you cite, quantity and destination port.
Receive a firm quote
Pricing, lead time, packing and Incoterm confirmed in writing within 24 hours — our sourcing desk is staffed around the clock.
Qualify and approve
Sample dispatched with the TSE and certification pack for your shell trials. Batch COA shared for approval before release.
Ship and track
Veterinary certification arranged, freight booked, export documents issued, and the consignment tracked to your plant.
What buyers ask us about Pharma Grade Gelatin
What is the difference between Type A and Type B gelatin?
What does bloom strength mean and which should I specify?
What origins do you supply?
What TSE documentation comes with bovine gelatin?
Is halal or kosher gelatin available?
What if we need a vegetarian alternative?
What is the minimum order quantity?
How should we store it?
Do you manufacture this yourself?
Request pricing on Pharma Grade Gelatin
Send your origin and certification requirement, type, bloom, the pharmacopoeias you cite, quantity and destination port. Our sourcing desk is available 24 hours a day, 7 days a week, and comes back with pricing, lead time and packing options.