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Excipient manufacturers pay attention to stability test

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A few days ago, the International Pharmaceutical Excipients Association (IPEC) claimed that excipient manufacturers have successively received inappropriate requests for stability data from some regulatory authorities and pharmaceutical companies. For this reason, these excipient manufacturers have threatened to interrupt the supply chain.

These requirements began last year. However, the number of requests made by regulatory agencies and pharmaceutical companies has accelerated in the first quarter of 2015, which prompted the trade organization International Pharmaceutical Excipients Association (IPEC-Americas) to publish a position Document to draw the attention of all parties concerned to this issue.

Jost Chemical Company is one of the excipient manufacturers, and they have all received letters requesting them to provide test data on “accelerated stability” or “stress”. Salt products such as potassium chloride produced by Jost are used as pharmaceutical excipients. A few weeks ago, it received the first request from the Ministry of Health of a South American country.

stability test
stability test

The guidelines are misunderstood

The IPEC-Americas position paper was written by a team led by Phil Merrell, Technical Marketing Manager of Jost. Merrell said that this problem occurred mainly because of the misunderstanding of the Q1A (R2) guidelines formulated by the International Coordination Conference (ICH) for the stability of new drugs and new products by regulatory agencies and pharmaceutical companies on the technical requirements for the registration of human drugs. The guide has been adopted since the early 1990s.

However, this position paper also pointed out that some excipient suppliers received issues regarding the inconsistencies between the storage instructions in the material safety data sheets (SDSs) and the product stability documents.

ICH Q1A applies to finished dosage forms and APIs, not bulk excipients. In fact, following this guideline will not give data under stress conditions.

Merrell said that the guidelines require stability testing to be carried out at room temperature and indoor humidity, which applies to finished products that are stored on pharmacy shelves or at home at room temperature. However, nine out of ten of the products used as excipients are transported and stored under uncontrolled conditions, because they have been generally considered stable for decades and have been used in pharmaceutical production. .

Merrell pointed out that providing the stability data of these products at room temperature does not really mean anything, it is a waste of time. In 2010, Merrell also joined a work team to help IPEC write a widely used excipient stability guide, which recommended that excipients should undergo stability testing in the warehouse where they are stored.


So, what prompted some regulatory authorities and pharmaceutical companies to put forward this series of requirements recently?

Merrell said: “I think some regulatory agencies have realized the reality that data at room temperature is not related to goods shipped under uncontrolled conditions around the world, and they have begun to request data under stress conditions. “

IPEC’s position is that manufacturers of excipients should provide data to show that the excipients are stable in marketing packaging under certain conditions, and such conditions may be encountered in uncontrolled warehouses.

As for those unstable excipients, the corresponding data should be generated on the basis of recognized scientific principles. If accelerated stability studies are carried out, these studies should be carried out under controlled storage conditions.

Merrell said that when the excipients arrive at their destinations, relevant parties require suppliers to provide stability data to show that the products are good. This approach is very meaningful. However, the use of ICH Q1A is inappropriate. It does not Any meaningful stability information will be added to these products.

He said that ICH Q1A should be rewritten to make it clear that it only applies to finished products stored under these conditions.

Call for non-retroactive clauses

Merrell pointed out that after the introduction of the guide, Jost had to spend millions of dollars, hire about 20 employees, and provide stability data for products that have been known to be completely stable for many years-even at temperatures In the case of great changes in humidity.

Merrell said that you can stick potassium chloride on your desk for many years and nothing will happen except for the accumulation of dust.

Merrell hopes to establish a non-tracing system for those excipients whose stability has long been known, and at the same time, put forward clear stability test requirements for new excipients, as stated in the IPEC stability guidelines. At the same time, this position paper also explains that storage conditions in SDSs should not be confused with real-time stability.

The document also pointed out that the information in the SDS is to meet the product labeling requirements related to the occupational safety and health of operators, and it is not linked to any pharmacopoeial terms, requirements or product stability test procedures.

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