Plan a trial for your application
Direct-compression granule evaluation
At the specified tablet design, machinery and target weight, record die filling, weight variation, hardness and disintegration. Retain the trial batch.
Qualifying a second supplier
Obtain active fraction, excipient composition and size distribution. Compare the proposed granules directly with the validated grade.
Purchase specifications and incoming inspection
Include the intended grade or current specification in the enquiry. Use the table to compare selection criteria and inspection conditions. The specification agreed by both parties defines the contractual limits. DailyMed · Granules India Compresso PAP 90 CPC original label ↗
| Property | Unit | Published or agreed specification | Test conditions and checks |
|---|---|---|---|
| Declared drug fraction | % | Granules Compresso PAP 90 CPC label example: 90%. | The value is for a third-party product series. Request composition and assay ranges for the specific grade offered. |
| Granule size | µm / % | Agree for the tableting equipment. | Record the sieve apertures and fractions to compare fines and coarse particles. |
| Tableting performance | Project-specific | Use the formulation validation plan. | Using the same equipment and target tablet weight, compare actual tablet weight, hardness, disintegration and dissolution. |
When approving a sample, record the grade, methods, limits and specification revision. On receipt, match the packing lot number to the lot-specific COA and record the measured values and release decision.
From samples to commercial delivery
Packaging and receiving
Outer and liner labels should identify direct-compression grade, manufacturing site and lot. Request composition and specification revision for pregranulated blends.
Storage and handling
State lab, validation and commercial batch quantities separately. Agree retention samples, lot consistency and change notification for each stage.
Sample and order lead times
State quantity and document-review milestones for R&D, validation and commercial batches. Confirm MOQ, quality release, dispatch and remaining time to retest at receipt.
Questions from the plant
Does passing a drug-substance monograph establish suitability for direct compression?
Have the formulation team evaluate fill, compression and dissolution on target equipment and review change control.
Will two direct-compression granules marked 90 reproduce tablet weight and dissolution?
The same percentage can involve different excipients and granulation. Match particle size, flow and compactability as well as assay, then test the actual formulation.
Report a delivery or batch issue
Include the order number, lot number from the package, label photos and inspection records for the affected lot. When retesting, check active fraction, excipient list, flow and compressibility.
Request documents for your application
TDS · Technical data sheet
For grade selection and sample approval, specify the grade and revision required.
SDS · Safety data sheet
Specify the country or region of use and the required language.
COA · Certificate of analysis
Request a sample COA during supplier review. For incoming inspection, provide the actual lot number.