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Quil-A® Specifications

Quil-A® Product Specification:

Quil-A® contains the water-extractable fraction of saponins from the South-American tree, Quillaja saponaria Molina.

These saponins belong to the group of triterpenoid saponins, that have the triterpenoid backbone structure in common.

Testing at final product level:

1) The dry matter content is tested.
2) The hemolyzing capacity is tested.
3) A High Performance Thin-layer Chromatography profile is prepared.
4) A HPLC chromatogram is prepared.

The dry matter content

The dry matter contentis tested to verify the efficiency of the lyophilization as a low water content in the final product is important for the shelf-life: 

Acceptance limit = 95%

The hemolyzing capacity

The ability of the saponin to hemolyse SRBC’s is an indirect read-out for the integrity of the saponin molecule, as degraded molecules loose their detergent activity:

Acceptance limit=<0.05%

High Performance Thin-layer Chromatography and HPLC

These tests are discussed below. In essence, both tests rely on a separation of the final product. Either in o a band pattern (HPTLC) on silica gel plates after selective migration in organic solvents or a peak pattern (HPLC) based one. g. elution times from a column after exposure to an acetonitril gradient.

Kindly note, that as neither of these two tests yield numerical read-outs, the final result evaluation relies on the overall pattern recognition by the experienced technician.

All Quil-A® batches are analyzed in HPTLC and an in-scanned copy of the chromatrogram is supplied to all customers, along with the Certificate of Analysis.

The HPTLC is carried out on MERCK silica gel plates, type 60 in a chloroform/methanol/CaCl2 medium. Running distance is 70 mm.

The Quil-A® sample is applied centrally on the plate and surrounded at both sides by a well-defined standard reference kit *, developed by Brenntag Biosector. See below for example. The HPTLC band pattern is deemed either acceptable or non acceptable.

* This standard reference kit is made commercially available to customers for potential use in their incoming control.

HPTLC (High Performance Thin-Layer Chromatography):

ReferenceKit ReferenceKit


Quil-A® sample

High Pressure Liquid Chromatography (HPLC):

Each batch of Quil-A® is analyzed by HPLC on a C-4 Vydaccolumn using an acetonitril gradient as eluent.

A copy of the chromatogram is enclosed with every delivery.

Below is an example * of such a chromatogram.

The HPLC peak pattern is deemed either acceptable or non acceptable.

* The example shown is from Quil-A® batch L-77-315.


Example of a HPLC chromatogram of Quil-A®

Regarding Ascorbic Acid:

Ascorbic acid (MW 176.12), also known as “Vitamin C”, is the enolic form of 3-oxo-L-gulofuranolactone. Quil-A® is available in two versions. One with 5 % ascorbic acid added as an antioxidant and one without. Ascorbic acid is a well-known antioxidant and fully tolerable, physiologically.

WAIVER:

Brenntag Biosector / E.M. SERGEANT guarantees the specifications above under the liability specified in the company’s "General Conditions of Sale and Delivery". However, individual customers may have internal specifications and/or acceptance limits or specifications which may include additional quality parameters reflecting their particular application of the product. Brenntag Biosector / E.M. SERGEANT does not accept to be held liable for any such additional parameter, nor guarantees any compliance with such, unless previously explicitly agreed in writing between the parties. It is the sole responsibility of the customer to test the product for any such parameter that goes beyond the standard specifications of Brenntag Biosector / E.M. SERGEANT
before adding the ADJUVANT to their vaccine.

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