TCS Industries Limited (China-sourced API supplier) supplies Pregelatinized Starch -– Binder & Disintegrant for Direct Compression CAS 68412-29-3 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Pregelatinized Starch -– Binder & Disintegrant for Direct Compression |
|---|---|
| Structural Formula |  |
| CAS Number | 68412-29-3 |
| Molecular Formula | (C6H10O5)n |
| Molecular Weight | Grade-dependent (polydisperse) |
| InChIKey | Not applicable (polydisperse polymer) |
| SMILES | Available on request where applicable |
| Appearance | White to off-white, moderately fine powder |
| Purity / Grade | By agreed specification and batch COA |
| Storage | Keep tightly closed in a cool, dry, well-ventilated place |
Pregelatinized Starch (CAS 68412-29-3) is a physically modified starch that has been processed (cooked and dried) to rupture starch granules, making it partially cold-water-soluble. It serves as a multifunctional pharmaceutical excipient: tablet binder, disintegrant, filler, and flow aid. Pregelatinized starch combines binding and disintegrant properties in one excipient, simplifying tablet formulations.
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Pregelatinized Starch in pharmaceutical (NF/Ph.Eur.) grade from corn and potato sources for global procurement programs.
> Applications
Tablet binder and disintegrant
Pregelatinized starch (5–20%) is used in direct compression and wet granulation as a combined binder-disintegrant. The cold-water-soluble fraction acts as a binder; the insoluble fraction swells and disrupts the tablet matrix (disintegration). Fully pregelatinized grades (Starch 1500 equivalent) have optimized soluble/insoluble ratios for direct compression. Gohel et al. (Pharm Dev Technol, 2004, 9:267–276) characterized the co-processed starch as a multifunctional excipient for tablet formulation.
Capsule diluent and flow improver
Pregelatinized starch provides acceptable flow properties for capsule filling and can serve as the sole filler-binder in simple formulations. It absorbs moisture from the formulation environment, helping maintain consistent moisture content in hygroscopic formulations.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Pregelatinized Starch -– Binder & Disintegrant for Direct Compression with buyers in South America, Europe, the United Kingdom, Australia, New Zealand, Mexico and Canada.
- Evaluation and commercial quantities: 25 kg bags for qualification; pallet for production. Fully and partially pregelatinized grades from corn and potato starch sources available.
- Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.
> Quality & Documentation
Key specification parameters include loss on drying (≤14.0%), residue on ignition (≤0.5%), pH (4.5–7.0), protein (≤0.5%), iron, oxidizing substances, sulfur dioxide (≤50 ppm), heavy metals (Pb ≤10 ppm), particle size, cold-water-soluble fraction (10–20% for partially pregelatinized), and microbial limits. White to off-white powder. Source (corn, potato) must be specified. Meets NF and Ph.Eur. (Amylum pregelificatum). COA and MSDS are standard.
> Packaging
Pregelatinized starch is a white to off-white, free-flowing powder. Slightly hygroscopic. Standard packaging includes 25 kg multiply paper bags with PE liner, palletized. Store at room temperature in dry conditions (≤65% RH). Shelf life is typically 36 months. Labels and documents are checked before dispatch.
> Pricing & MOQ
Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.
> Regulatory & Compounding Context
Pregelatinized starch is monographed in NF (Pregelatinized Starch) and Ph.Eur. (Amylum pregelificatum). Listed in the FDA IID for oral dosage forms. Derived from native starch (corn, potato, wheat) — considered a food-grade material. GRAS in the US. No special import permits. Wheat-derived requires allergen declaration.
> Alias Index
- Chemical class: Physically modified starch (pregelatinized)
- CAS Number: 68412-29-3
- Pharmacopoeial name: Amylum pregelificatum (Ph.Eur.)
- Starch sources: Corn (maize), Potato
- Brand equivalents: Starch 1500 (Colorcon), Lycatab PGS (Roquette)
- Related excipients: Native starch, Sodium starch glycolate, Maltodextrin
- Commercial request terms: pregelatinized starch NF, Starch 1500 equivalent, direct compression starch, multifunctional binder-disintegrant, TCS Industries Limited
> FAQ
What is the difference between pregelatinized and native starch?
Native starch is insoluble in cold water and swells only in hot water. Pregelatinized starch has been physically processed (cooked and dried) to partially solubilize the starch granules, making it partially cold-water-soluble. This gives it binding properties in addition to the swelling disintegrant function of native starch.
What documents are available for Pregelatinized Starch -– Binder & Disintegrant for Direct Compression orders?
COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.
Can TCS Industries Limited support Pregelatinized Starch -– Binder & Disintegrant for Direct Compression supply to South America?
Yes. We support B2B buyers in Argentina, Colombia, Chile, Peru, Ecuador, Uruguay, Bolivia, Brazil, Paraguay, Venezuela, Guyana and Suriname, subject to route and document review.
Do you support Europe, the United Kingdom, Australia, New Zealand, Mexico and Canada?
Yes. These destinations can be reviewed for project supply, import documents, packaging and logistics planning before quotation.
Is pregelatinized starch suitable for direct compression?
Partially pregelatinized starch (Starch 1500 equivalent) is suitable for direct compression. Fully pregelatinized starch has better compressibility but poorer flow. Native starch is not suitable for DC. For direct compression, specify “partially pregelatinized, direct compression grade” at inquiry.
Does pregelatinized starch contain gluten?
Corn and potato-derived pregelatinized starch are gluten-free. Wheat-derived pregelatinized starch may contain trace gluten. Specify the starch source and gluten-free requirement at inquiry. Most pharmaceutical-grade pregelatinized starch is corn-derived.
Can you arrange samples before commercial purchasing?
Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.
How is Pregelatinized Starch -– Binder & Disintegrant for Direct Compression packaged for export?
Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.
Can buyer-defined specifications be reviewed?
Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.
What payment terms are normally used?
Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.
What lead time should buyers expect?
Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.
How does it compare to other binder-disintegrants?
Pregelatinized starch provides combined binding and disintegration at 5–20% concentration. MCC provides stronger binding; super-disintegrants (CCS, PVPP, SSG) provide faster disintegration at lower concentration (2–5%). Pregelatinized starch is chosen when formulation simplicity (one excipient for two functions) is prioritized.
Last reviewed: June 2026
Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.
> Request a Quote
If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.