What a softgel or tablet COA actually contains

The one-page sheet

Every batch leaves with a certificate of analysis. The parameter list is fixed by the dosage form; the results change with the batch. A COA that lists only the active marker is not enough for a softgel or a tablet, because the dosage form itself has to be tested: fill weight, shell integrity, hardness, disintegration and moisture are release parameters, not optional extras.

Batch results are recorded on the COA supplied with each shipment. A sample COA for the current batch of any product in this category is available on request.

What a softgel COA contains

A softgel has two parts: the fill and the shell. The COA has to describe both. The fill is assayed for its marker; the shell is checked for seam integrity, thickness and appearance. A softgel that passes the fill assay but leaks at the seam is still a failed batch.

The fill weight is the first number a buyer should check. Softgel tooling is built around a nominal fill; the batch result should sit close to that nominal, and the individual range should be stated rather than implied. If the fill weight drifts, the label claim drifts with it.

What a tablet COA contains

A tablet has a compaction history. Hardness, friability and disintegration are the three numbers that show whether the formulation was compressed sensibly. A tablet can pass the assay and still fail disintegration; that is why the pharmacopoeia tests the dosage form, not only the powder.

For coated tablets, the coating weight and the coating uniformity belong on the batch record. For enteric-coated tablets, the acid-resistance test is part of the release; a coating that dissolves in the stomach is not an enteric coating.

Marker assays by product family

“Assay” means different things for different products. The table below lists the marker and the method that are used for each family in this category. The release limit is written into the specification for the individual product; the method is what makes the number comparable between laboratories.

Two laboratories can differ by one or two percentage points on the same powder because of column, mobile phase, wavelength and standard. When you compare quotations, compare the method as well as the number.

Release limit vs batch result

The release limit is the window we promise for every batch. The batch result is what this specific batch measured. Both belong on the COA, and the difference between them is where most purchasing arguments start.

If your incoming inspection uses a tighter window than the release limit, send us that window before the order. It is easier to select or adjust a batch before packing than to argue about a deviation after arrival.

In-house COA vs third-party report

Most COAs, including ours by default, are issued by the manufacturer's own QC laboratory. That is normal: the batch is released against that result. When your customer or your importer needs an independent report, ask for SGS or Eurofins by name and specify the tests. Third-party testing is arranged per order; it is not a substitute for the release COA, it sits beside it.

What changes between batches

• Marker result — a 95% specification often lands at 96–97%; a 55% protein specification can land at 57%. That is normal, not a premium grade.
• Colour — oil colour, algae colour and shilajit colour move with the raw material. If colour is critical, specify a range and ask for a retention sample.
• Tablet hardness — a small change in granulation moisture moves hardness. The release range is set so that disintegration still passes.
• Fill weight — softgel shell thickness and fill weight move together; the individual range is agreed at tooling.

Product-specific notes

Each row maps one product in this range to the parameter this document controls. The product pages link back to their own row; when you compare two products, compare the method column before the number.