Understanding the material
The 8.5% loading provides a lower active concentration per unit mass than a 22.5% grade. For the same active quantity it requires more pellet mass, before adjustment for the measured assay. This can influence capsule capacity and filling settings. Enteric coating performance is central to the product: active loading alone does not establish delayed-release performance.
Product Identity & Specifications
Chemical identity, physical characteristics and key specifications for Omeprazole Pellets 8.5% WW.
| Parameter | Description / value | Basis / application |
|---|---|---|
| Product identity | Omeprazole enteric-coated pellets | Multiparticulate intermediate |
| Nominal active loading | 8.5% | Product-line designation |
| Assay expression | Active-equivalent content on stated basis | Current specification and COA |
| Active form | Omeprazole; salt / hydration as specified | Especially relevant to esomeprazole grades |
| Physical form | Coated discrete pellets | Appearance is grade specific |
| Pellet size | Selected sieve distribution | Common manufacturer options include 14/20 and 20/30 mesh |
| Size method | Sieve standard and retained fractions | Mesh numbers require a defined sieve system |
| Bulk density | Grade-specific measured value | Capsule volume and filling behaviour |
| Acid-stage performance | Tested against the agreed release specification | Gastro-resistant coating assessment |
| Buffer-stage dissolution | Defined medium, time and acceptance criteria | Delayed-release performance |
| Water / moisture | Controlled in the pellet specification | Storage and coating stability |
| Related substances | Active-related impurity profile | Analytical and stability assessment |
Identity and published standard
Omeprazole enteric-coated pellets — manufacturer specification
Published manufacturer information lists omeprazole pellets at 8.5% and 22.5% loading with selectable sieve grades. These are formulated intermediates: active identity, loading, acid resistance and dissolution are defined by the selected pellet specification. A finished-dosage-form monograph does not by itself establish conformity of every pellet grade.
View published product informationThe selected pellet specification and current COA define the offered grade and its quality results.
For further information and current COA/specification, please contact us.
Request current COA & specificationApplications & functional benefits
Capsule filling
Omeprazole enteric-coated pellets can be evaluated for hard-capsule manufacture. Match pellet size, density and flow to the filling equipment and confirm performance after processing.
Multiparticulate development
The 8.5% loading offers a defined starting point for pellet-mass calculations. Assess segregation, filling variation and the required dosage-form volume during development.
Qualified MUPS processing
Tablet manufacture requires a pellet grade specifically qualified for compression. Cushioning excipients and compression conditions must preserve the functional coating.
Omeprazole pellet strengths and processing grades
| Grade / form | Main distinction | Selection consideration |
|---|---|---|
| 8.5% loading | Lower active loading per mass of pellets | Larger nominal pellet mass for the same active quantity. |
| 22.5% loading | Higher active loading per mass of pellets | Evaluate density and capsule fit alongside assay. |
| Compression-qualified grade | Coating designed and tested for the intended process | A capsule-filling grade is not automatically a MUPS grade. |
Formulation & processing
Use the measured pellet potency
Calculate the manufacturing input from the approved active-equivalent assay and its reporting basis. The nominal percentage is a product designation, not the measured potency of every batch.
Protect the coating during handling
Choose transfer, blending and filling conditions that minimise abrasion and pellet fracture. Reassess release performance after any process likely to damage the enteric layer.
Specify the complete release test
Acid resistance and subsequent buffer-stage dissolution answer different questions. Include the medium, apparatus, sampling times and acceptance criteria in the agreed product specification.
What to check in the specification
- Active form, nominal loading and assay calculation basis
- Sieve range, size distribution, bulk density and flow
- Acid resistance and subsequent dissolution performance
- Coating integrity, moisture and stability through processing
Current product documentation
Request current COA, pellet specification, assay basis, sieve analysis and release-test information. Include your filling or compression process so coating and stability requirements can be clarified.
Request documents for Omeprazole Pellets 8.5% WWPacking, storage & handling
Packing and quotation details
Discuss the required net weight, sample quantity and delivery schedule with SBS. Packaging should be compatible with the material and carry product, manufacturer and batch identification. Confirm the offered pack size and shelf-life or retest information in the quotation; these depend on the selected grade.
Storage and safe handling
Keep the pellets in the original sealed moisture-protective packaging under the manufacturer’s specified conditions. Minimise exposure during dispensing, avoid crushing or excessive abrasion, and follow the current SDS and retest instructions.
Frequently asked questions
Does 8.5% specify pellet size?
No. Active loading and sieve grade are independent characteristics; both are identified in the product specification.
Can these pellets be compressed into tablets?
Only a grade qualified for the intended MUPS process should be used. Coating integrity and release performance must be demonstrated after compression.
How do I obtain current quality information?
Contact SBS for the current COA, assay basis, sieve analysis, release-test information and available stability documentation.
Technical information sources
Need more information?
Contact SBS for further product details, current COA, specification, packing and a quotation for your requirement.
Contact SBS for details and documents