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Storage and Retention Considerations when Sampling Pharmaceutical Products and Related Materials

For companies that are in the business of manufacturing and distribution of pharmaceutical drugs or intermediates such as Bis (2-chloroethyl)amine hydrochloride and 3- Dimethylaminopropyl chloride hydrochloride find that WHO lays down some highly elaborate guidelines as to how the sampling products need to be stored and retained. Here are some of the highlights from those guidelines –

  • Make sure that the container that is used to store the sample at no point interacts with the already sampled material or leaves room for any contamination.
  • Necessary measures should be taken to protect the sample from moisture, air and light as specified.
  • The container in which the sample is stored should be tamper-evident and sealed.
  • Liquid samples are required to be transported in suitable bottles that are tightly closed with screw tops and inert liners that enable moisture-proof sealing.
  • Some solid and semi-solid pharmaceutical products may also require suitable screw-top jars.
  • Light and sensitive materials such as 2-Dimethylaminoisopropyl chloride hydrochloride needs to be protected through amber glass containers or by wrapping foil on transparent glass.
  • With the purpose of minimizing degradation, it is important that one maintains minimum headspace.
  • Make sure that granules, tablets and other solid dosages are protected at the time of transit. This can be done by completely filling up the container with the product or by filling the remaining space with other suitable materials.

The WHO also lays down guidelines on how the containers need to be sealed and labeled and how every package should be packed and marked for adequate protection and identification during and after transit.

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